Principal Scientist Resume Samples

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H Ziemann

Herminia

Ziemann

957 O'Kon Shore

Detroit

+1 (555) 200 2746

957 O'Kon Shore

Detroit

Phone

p +1 (555) 200 2746

Experience Experience

Phoenix, AZ

Principal Scientist

Phoenix, AZ

Hauck Inc

Phoenix, AZ

Principal Scientist

Develop and execute laboratory workplans/schedules for self and team, using customer milestones and Division/site performance standards and metrics
Interacts with internal staff and management to identify assays requiring further improvements or development and oversees improvement of these assays
Supervises technical staff, including work assignments and performance and development management
Assist in the development of test methods for process improvements
Manage individuals that develop and implement regulatory strategy to support lifecycle management of In-line products
Assist in training junior level staff and guide the work of these individuals on the development team
Interpret, evaluate, communicate and properly document the results of development work and make recommendations for action

San Francisco, CA

Principal Scientist, Sequencing

San Francisco, CA

Feest-Steuber

San Francisco, CA

Principal Scientist, Sequencing

Creating insightful, simple graphics to represent complex trends
Operating genomics platforms and instruments
Working alongside research assistants and other groups to troubleshoot experiments and their associated analyses
Maintaining a detailed log of research results
Using command line tools to perform data conversion and analysis
Operating research automation devices
Quickly writing scripts to automate routine analysis tasks

present

Chicago, IL

Principal Scientist, Analytical Technology

Chicago, IL

Kilback, Stamm and Satterfield

present

Chicago, IL

Principal Scientist, Analytical Technology

present

Applies expert knowledge of scientific/technical principles & concepts
Lead and / or facilitate meetings and provide progress tracking and updates to leadership
Provide technical assessments for proposed changes to specifications and methods for raw materials, API, in-process intermediates, and drug products
Manage analytical activities and projects to meet the strategic and project goals
Represent Analytical on cross-functional project teams
Active member of tech transfer teams and take lead technical role for method transfers, qualifications and validations
Ensure training is current and compliant

Education Education

Bachelor’s Degree in Chemistry

Northern Illinois University

Bachelor’s Degree in Chemistry

Skills Skills

Base knowledge of the W3C’s Web Content Accessibility Guidelines v2.0
Exposure to current tools used by people with disabilities (screen readers and other assistive technologies)
Experience with accessibility evaluation and validation software
Understanding of input and output modes used by people with disabilities
Job title: Principal Scientist Asia Clinical Supplies, Pharma Development & Manufacturing Sciences (PDMS)
Sector: Pharmaceutical
Location: Seoul, Korea or China or India
Knowledge in large molecule drug substance process development and manufacturing
Specific expertise: Clinical Manufacturing, Process Engineering & Scale-up
Elementary technical background (mechanics, electrical, PLC, …)

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15 Principal Scientist resume templates

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Principal Scientist, Drug Product MS&T Resume Examples & Samples

Identify and manage product and manufacturing process improvement throughout the lifecycle of commercial biologics drug products - 30%
Provide technical support for deviations, change controls, and GMP investigations for global commercial drug product manufacturing and product complaints – 30%
Represent within cross functional project teams including commercial CMC teams – 10%
Minimum, M.S. degree in engineering, chemistry, or related science

Principal Scientist Immunoassay Analytical Development Resume Examples & Samples

Development, improvement, training, qualification and transfer of HCP and other ELISA methods
Leads the development and execution of standard and alternate platform immunoassay methods, specially the human host cell protein ELISAs for process development and release testing
Leads and performs method qualification and preferably validation as per USP and ICH guidelines
Writes protocols and technical reports, ensures adherence to high technical standards and compliance with applicable regulatory guidelines in the generation and interpretation of data
Provides process development support to internal and external manufacturing sites and leads technical initiatives
Ph.D. in Analytical, Chemistry, Biochemistry and Pharmaceutical or other biotechnology-related discipline with a minimum of 5 years relevant industry experience in product and process development with documented experience in the area of host cell protein characterization and method development
Demonstrated hands-on experience with standard and alternate platform immunoassay methods, specially the human host cell protein ELISAs for process development and release testing
Strong and effective interpersonal skills and demonstrated leadership to provide direction to multiple program teams in a fast paced, multi-product biotech company
Ability to communicate clearly and concisely verbally and in writing; preferably has demonstrated experience and skills in authoring regulatory submissions

Principal Scientist, Nail Resume Examples & Samples

Innovation process
Long and Mid-term NPD Project management
Technology platform development
Co-responsibility for Innovation pipeline and its execution
Significant record of achievement in the development of new products/technologies
Resource management efficiently and creatively
Responsible for managing innovation group including project and team management as well as bench formulation
Success records within an Innovation role and/or environment
Strong computer skills (MS Word, Excel, PowerPoint)
Strong leadership skills required, yet lead by example
Able to work in a fast paced environment

Principal Scientist Resume Examples & Samples

PhD in life science (preferentially immunology) with more than 10+ years of industry experience
Experience in leading biological molecule PK and biodistribution ,ADA, and biomarker studies in various matrices and tissues to support both non-clinical and clinical studies
Experience with departmental representation on cross functional project teams
Strong knowledge of the drug development phases and the associated bioanalytical requirements
Experience in placing and managing external work at CROs/CMOs is required

Basic Research Principal Scientist Resume Examples & Samples

Proven record of independently leading, creating and launching multiple Innovative Technical Platforms in Color Cosmetics (i.e., EYE/FACE/LIP products)
Skilled in Open Innovation (internal and external ideas and paths) to develop breakthrough technologies, including sharing of risks and rewards with partners
Ability to independently solve complex problems and technical challenges under pressure
Knowledge of Physical Chemistry of raw materials and ability to characterize raw material properties and makeup benefits using quantitative methods
Proven ability to create technology platforms and Innovation based on Consumer needs
Proven ability to transfer technology from different industries to the cosmetics arena
Proven ability of successful collaboration with Universities, Chemical suppliers to create or optimize breakthrough technologies/chemicals that are unique and proprietary and not available to the general market
Proficient in creating, evaluating and implementing targeted research programs with external and internal partners
Proficient in delivering innovative technologies, i.e. raw materials, from Concept to commercialization
Has knowledge of key intellectual properties in color cosmetics arena
Proven ability to compile and file patents in association with patent attorneys to protect breakthrough technologies
Proven ability to amend and optimize patents collaborating with the government patent examiners and company patent lawyers to help accelerate the process to achieve granted status
Proven ability to effectively interact and collaborate with Development lab personnel (Management and Chemists to bring breakthrough technologies quickly to the market place), Support Groups such as Product Safety, Analytical laboratory, Regulatory, Pilot teams, etc
Capability and ability to act as a technical/scientific advisor
Ability to promote and characterize innovation in a visual and impactful manner for presentation to management, technical and non-technical partners/audiences
Familiarity and expertise in pigmented makeup formulation, i.e. Aqueous and anhydrous systems, emulsions, loose and pressed powders; different forms such as hot pours, creams, lotions, liquids, sticks, etc
Ability to meticulously and methodically conduct various required product stabilities to effectively evaluate and understand viability of technologies for the market
Significant record of achievement in the delivery of new products/technologies within the industry
Skilled professional with proven ability to manage and organize multiple projects and ability to effectively communicate with diverse group of collaborators/teams
Strong presentation skills to communicate project background, technologies utilized milestones, progress, consumer benefits, etc
Minimum M.S. and/or Ph.D. degree(s) in Chemistry, Polymer Science, Chemical Engineering, or Materials Science
8+ years relevant industry experience for M.S. Degreed candidates
5+ years relevant industry experience for Ph.D. Degree candidates
Strong fundamental Scientific background
Ability to prepare concise, clearly written memos/documentation
Ability to utilize Microsoft Office (Outlook, Word, Excel, Power Point, Lync, etc

Principal Scientist Resume Examples & Samples

Be accountable for developing solutions to complex problems linked to short and long term business needs
Research and develop innovative and sensitive methodologies to evaluate various aspects skin/ hair appearance and physiology and analyze differences / changes in these parameters
Be able to work independently in cross functional teams and be capable of presenting scientific testing results and technical insights to both technical and non-technical audiences
Establish collaborations with research partners and external research laboratories to develop new technologies/methodologies
Lead in-house and external research projects to develop novel non-invasive methods to evaluate efficacy and substantiate claims
Provide clinical study design expertise and support to innovation and product development teams
PhD scientist/engineer with experience in biomedical optics, spectroscopy, image analyses, photobiology and material science
3-5 years in dermatological research, skin models or clinical testing experience
Computer programming skills in Labview, Matlab or IDL
Experience developing innovative/ingenious solutions for complex technical problems that may include the design of new systems, protocols, or methods or the development of solutions to problems having few or no precedents. Problems are often complex, and solutions are often highly innovative and ingenious
Must be able to demonstrate understanding of statistics in clinical study design / interpretation of data, draw meaningful conclusions and recommend appropriate next steps
Must maintain a high degree of flexibility to accommodate fluctuating priorities in a fast paced environment
Must function as a team player working in a highly matrixed environment

Principal Scientist, Analytical Technology Resume Examples & Samples

30% Commercial CMC Team Lead, Product Technical Team Lead, and Product Technical Team Facilitator
Normally requires an advanced degree in Chemistry, Engineering or equivalent scientific/technical discipline with 8-12 years related experience or a BS with 12-15 years
Applies expert knowledge in methods development, optimization, validation and technology transfer
Knowledge of relevant cGMP, ICH and global Regulatory CMC guidance documents
Previous experience in preparing and submitting regulatory filings and/or briefing packages and/or as a regulatory inspections technical SME
Experience in problem-solving methodologies
Ability to evaluate potential CROs and CMOs from all aspects of methods development and analytical technology

Principal Scientist, Adobe Document Cloud Resume Examples & Samples

Enterprise products
Web Development; including SOA-based Java Web Services
JavaScript frameworks, such as AngularJS, Backbone, Node.js
Java/Spring/RESTful API/JMS
Lean Startup methodologies
Data Analytics / Business Intelligence
Demonstrating Strong EQ (Be Aware) – Having a keen sense of self awareness is the foundation of leadership at Adobe. As a leader, we look to you to inspire teams to greatness with empathy and mindfulness of your impact on others from interns to the Board of Directors. And whether you’re in headquarters, New York, London, Tokyo or Bangalore, you’re attuned to emotional, situational and cultural surroundings and adapt your approach accordingly
Scaling the Business (Be an Owner) – You’re someone who sees and understands the vision of the company. You’re able to articulate business strategy and develop business processes, systems and structures to make performance sustainable. Your mission is to deliver an exceptional customer experience by promoting shared goals and driving accountability

Principal Scientist Resume Examples & Samples

Liaise with discovery biologists, bioanalytical scientists, non-clinical and clinical teams, as well as external collaborators to set biomarker goals/expectations and implement innovative techniques to identify and validate biomarkers (e.g., target engagement, mechanism of drug action, pharmacodynamics, proof of concept, etc)
Responsible for designing, implementing and managing a wide range of biomarker discovery, assay development, validation, sample analysis, and reporting in accordance with appropriate regulatory compliances
Broad experience in biomarker discovery and development utilizing nanoLC-MS/MS based proteomic profiling, as well as ligand-binding assays
Effectively manage outsourcing in CRO to deliver high quality results in a timely manner (method transfer, validation, troubleshooting, and data analysis, etc)
Establish new bioanalytical capabilities and introduce new assay technologies to address challenging technical issues
Write and review assay validation and bioanalytical reports and provide training and mentorship to internal staff. Contribute to clinical study report and other regulatory documents. Write scientific manuscripts for publication
50% - Design biomarker strategy and implement high complexity bioanalytical assays
20% - Manage external vendors/CROs to meet sample testing timelines
10% - Performs high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards
10% - Represent Biomarker group in various project team meetings
10% - Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication
Ph.D. degree in biology or chemistry with a minimum of 7-10 years of industry experience in biomarker research and assay development

Principal Scientist Resume Examples & Samples

Lead and conduct work on analytical-based projects supporting all areas of the business involving beauty, cosmetic, and personal care products
Work independently, utilizing a broad range of analytical techniques and scientific knowledge, to arrive at conclusions that guide business decisions
The candidate is expected to be active in work on the lab bench
Be a technical expert for the Analytical group, having a thorough understanding the capabilities and applications of a wide range of analytical technique
Explore and evaluate new analytical technology and methodology for potential application to innovative researc
BA/BS or MS degree in chemistry or equivalent scientific discipline with a minimum of 8 years experience or a Ph.D. with at least 5 years experience
Broad and in-depth knowledge of analytical chemistry techniques, including chromatography (HPLC, GC), spectroscopy (IR, UV/VIS), DSC, wet chemistry techniques (experience with scanning electron microscopes is a plus)
Strong problem solving skills and the ability to develop creative, innovative, and scientifically sound solutions
Highly flexible, adaptive to changing business priorities and completing projects in a fast-paced work environment

Principal Scientist Resume Examples & Samples

) Taste Biology (Neuro Sensory, Sweetness Discovery, Ingredient Discovery) Required
) Health & Wellness for Ingredients & Products Required
) Consumer Segmentation (Genetics, Bio Markers)
) Sustainable Sourcing (Fermentation, Bio Conversion, Agricultural Sciences)
Bring new and best technologies to achieve the Global R&D strategy
Develop new strategies and augment existing strategies
Educate, communicate and influence strategy and tactics
Set and influence strategic courses
Drive towards best positioning long term for the Company around innovation, capturing consumer-preferred, future innovation
Be a global thought leader, subject matter expert and influencer internally and externally
Be a pipeline builder in Ingredients & Ingredients Technology
Communicate strategic agenda and tactics effectively to internal and external stakeholders
Demonstrate the ability to interface with various stakeholder and audiences. Communicating with leaders, peers, vendors, etc
Demonstrate the ability to build internal and external credibility with integrity
PhD in molecular biology, genetic biology
A minimum of 10 – 15 years of related experience in relevant industries (i.e.: Ingredient Sciences & Discovery, Bio Technology- based Agricultural Sciences, Bio Medicine, Pharmaceutical Sciences, etc.)

Principal Scientist Resume Examples & Samples

Has experience developing native applications for the iOS platform
Gets excited about solving big problems
Understanding of input and output modes used by people with disabilities

Principal Scientist Resume Examples & Samples

30% - Technical Leadership – Supports development of and owns execution against NA Oils & Shortening R&D Customer Focused Innovation (CFI) portfolio ensuring full alignment with global business strategy. Translates CFI strategy into action plans through identification and implementation of technical solutions to drive product differentiation. Responsible for all technical aspects of the product development life cycle from ideation/concept, bench & pilot scale testing, commercialization and validation along with development and coordination of the intellectual property strategy. Drives search & reapply activities across the globe
25% - Technology Partnerships - Ensures foundational R&D in place to support CFI initiatives. Identifies technical knowledge gaps and leverages internal and external technology partnerships to ensure successful execution against projects. Manages foundational research projects with our Global Food Research team (GFR) and other technology partners ensuring scope, progress and relevancy is tracking. Drives technology scanning activities, actively seeking/exploring external distruptive and enabling technologies that can drive differentiation in the portfolio. Responsibilities include leadership role on the Discovery Team which connects/align Product Group and GFR activities. Supports work as needed through hands on experimentation. Ensures appropriate protection of Cargill intellectual property
25% - Business Development & Customer Interface – Levers technical expertise to identify and drive new business opportunities. R&D tag for strategic customers, as assigned. Responsibilities include leveraging technical expertise & Trusted Advisor approach to foster deep R&D partnerships to achieve customer’s volume/margin/growth goals. Partners to develop deep understanding of customer’s strategy to deliver differentiated solutions. Proactively provides troubleshooting and technical support and service
20% - Technical Development/Mentorship – Technical go-to person for internal stakeholders for trouble shooting and creative problem solving against technical/formulation challenges. Represents Cargill at industry meetings/conferences through technical presentations. Provides technical thought leadership for ideation and development of CFI and HPI pipelines. Responsible for team technical growth through strong mentorships
Bachelor's degree in Food Science, Chemistry, Chemical Engineering or closely related field
10+ years food industry experience in Product Development, Technical Service or Process Engineering role
Deep industry experience/expertise in food oils formulations, processing and applications
Ability to pull together diverse, cross functional teams to solve problems and pursue opportunities
Estimated 25% travel
Ph.D. in Food Science, Chemistry, Chemical Engineering or closely related field
15+ years R&D Food Industry experience
5+ years R&D food industry experience in product development focused on oils formulations, processing and applications

Carbohydrate Principal Scientist Resume Examples & Samples

50% Technical Leadership
You independently conduct highly complex research using traditional and non-traditional data sources to study discovery and development of carbohydrates with new/improved functional benefits
You contribute to and lead activities to build capabilities in functionalities in carbohydrates, e.g. from the knowledge of different sources of carbohydrates (including simple sugars, fibers, bulking agents, hydrocolloids and other polysaccharides), chemistry, use of carbohydrates for functionality, health and wellness, and processing technologies ( extraction, fractionation, extrusion, encapsulation)
Your creativity helps you to formulate new ingredients and ingredient systems to impart unique functional, nutritional and quality characteristics in foods and feeds, and functional and quality characteristics in bioindustrial areas
You bring expertise to the project teams working on carbohydrate chemistry and its interactions with other ingredients in food and feed matrices. Your expertise allows you to interpret interactions with other ingredients in product formulations
20% Connectivity and Collaboration
You contribute to and/or lead client-driven projects related to carbohydrates with colleagues from research, applications and business technology specialists
Develops strong business/customer understanding to ultimately influence/drive and create business opportunities. Anticipates emerging technology needs for Enterprises/Businesses and proposes solutions within the area of carbohydrate and complex carbohydrates focus
You build and maintain a knowledge base in the area of expertise, you connect with colleagues in the field within Cargill, within academia and with our customers. You are able and willing to represent Cargill at technical conferences
15% IP Leadership
You lead/contribute to inventions and for intellectual property protection in your area of expertise
Provides technical expertise to support Intellectual property and intellectual asset application process and to secure innovation property rights
15% Project Management
Assure proper execution of complex, multidisciplinary projects through planning, resource allocation, milestone definition and budget management
Develops and documents plan for complex long-term projects, including high level equipment and capabilities required inside and/or outside of Cargill. Identify project success measures. Designs high complex experiments, establishes the trials protocols for a new/complex carbohydrate technology
Assure adequate resources are engaged to deliver technical success. Prepare or review detailed technical reports for the project team, the BU client, Internal Applications or PPD teams. May delegate specification documentation to more junior team members
You are accountable for project timeline and good laboratory practices, for experimental planning. You report results in written and in oral presentations to cross-functional audiences
Travel approximately 15%
M.Sc. in Chemistry, Biochemistry, Food Chemistry, Food Technology or related fields
7+ years of Industry experience in carbohydrates
Deep knowledge in Carbohydrate and Cereal Chemistry and Biochemistry; understanding the underlying mechanism of chemical and biochemical conversion routes, with strong focus on separations, enzymatic and organic chemistry
Demonstrated track record of developing and cultivating relationships within a global organization
Demonstrate excellence in expertise area, work with limited direct supervision and ability to innovate, transform knowledge into value
Demonstrated leadership skills- integrity, conviction, courage, execution capacity and behaviors knowledge, business acumen
Demonstrated collaboration skills
Ability to communicate effectively to different audiences- R&D, businesses, sales and marketing, customers, and consumers
Ph.D. in Chemistry, Biochemistry, Food Chemistry, Food Technology or related fields
10 years of Food industry experience in carbohydrates
Complex carbohydrates experience
Multi-disciplinary skills: polymer chemistry, carbohydrate physical properties and interactions with other ingredients , Chemical processing and analytical methodology as related to carbohydrates
Demonstrated good technical writing skills and presentation skills in professional journals and organizations

Principal Scientist Resume Examples & Samples

Provide leadership and strategic direction to Cargill businesses by developing and executing global regulatory strategies aligned with commercial objectives.(20%)
Develop scientific assessments and secure regulatory approvals to support commercial uses for new Cargill products. Manage internal and external experts, CRSs, and other resources, develop project plan and prepare scientific support documentation for regulatory compliance and science-based regulatory submissions, in the US and globally, e.g., GRAS notifications, novel food petitions. Liaise with customers and governmental officials regarding submissions. (40%)
Actively engage business and technology counterparts, internal and external experts, government authorities, and industry partners and customers to ensure application of best practices in areas of nutrition, safety and human health risk assessment, regulations and policy developments, and other scientific issues in alignment with Cargill policies and commercial business objectives. Develop techniques and standards that can be utilized by SRA peers for scientific substantiation of safety, efficacy, claims, and regulatory compliance. (20%)
Participate in external trade and science-based initiatives (e.g. ILSI, IFIC, GMA ) and proactively assess regulatory and policy developments in the field nutrition, safety, regulatory and their impact to Cargill Business. (10%)
Leverage expertise to exercise informal leadership to develop SRA employees and resources to ensure a critical mass of engaged scientific experts with required support to achieve the growth objectives of Cargill's Food and Feed Ingredients. (10%)
Strong desire to work in food industry
Willingness to travel (up to 30%)
M.S. degree or equivalent in Nutrition, Food Science or related life sciences
5 + years of work experience in regulatory affairs and Nutrition research including pre-clinical studies, clinical trials and other methodologies to conduct human and/or animal health assessments
Strong knowledge of food and/or feed regulations, specifically pertinent to food safety and human health
Experience in the conduct of toxicology and/or clinical studies
Knowledge of the nature and type of scientific and technical data necessary to support the safety and regulatory approval of food ingredients in jurisdictions worldwide
Experience in preparing regulatory and scientific submissions
Effective project management skills to manage multiple projects, cross-functional project teams, external resources and customer interactions
Clear leadership and organizational skills
Ability to review and summarize scientific literature and data pertaining to nutrition science, chemical food safety assessments, and other sciences pertaining to food regulations
Ability to bridge scientific and business objectives

Principal Scientist R&D Resume Examples & Samples

Develop and articulate to key internal and external customers Honeywell’s future flight deck architecture strategies and designs
Apply an understanding of the needs of Next Gen ATM, UAS in NAS, future vertical lift, and fixed wing aircraft advances as they apply to development of advanced flight deck architectures
Work with Marketing and Product Management to engage customers toward enhancing understanding of key user needs for future flight decks with an emphasis on visualization and user interaction through application of VOC and OVOC principles and techniques
Work with our Flight Test organization to develop advanced crew interface technologies to apply to our future flight deck offerings
Apply advanced systems engineering techniques to enhance flight deck offerings through in-depth understanding of emerging system design and validation techniques
Develop and deploy linkage to overall aircraft architecture advances for future platforms by active participation in platform development efforts supporting general aviation, business aviation, air transport, and military flight deck needs
Develop and deploy strategies for aligning future flight deck designs with environmental drivers such as connectivity, autonomy, and software tool design
Participate in the broader research community, for instance through publications, and collaboration with other internal and external research organizations
Understand new technology trends and apply them for future Honeywell products
Support development of research proposals for funding by external and internal sponsors
The preferred location for this role is Phoenix, AZ **
MS degree in a Engineering/Scientific discipline
8 years of experience aircraft systems design
6 years experience in an academic, research, or industrial organization focused on aerospace systems flight deck design
A PhD degree in a relevant Engineering/Scientific discipline with 6+ years of experience in aerospace/flight deck design
Originality and creativity
Ability to lead research teams and to contribute to teams led by others
Strong bias for action
Passion for new learning
Ability to proactively work in a dynamic research environment
Background in industrial design a plus
Experience with rapid prototyping, flight operations, and display technology preferred
Ability to communicate well and influence both internal and external stakeholders
Commercial pilot rating
US Citizen or Permanent Resident preferred

Principal Scientist, Data Sciences Resume Examples & Samples

Address complex problems with broad implications for research data, balancing the often competing needs of privacy and utility
Ensure solutions are consistent with business objectives or business strategy
Make decisions regarding resource alignment/dedication and prioritization (people resources, dollars/funding, project criticality) and communicate rationale back to the business and project management
Contribute to the strategic planning process and long-term direction for the Privacy and De-identification team and aligns plans between stakeholders
Deep understanding of statistics relating to de-identification and privacy, serving as a resource to others
Strong understanding of technology trends and the potential impact on the security of clinical data
Strong understanding of the business and its operating environment (e.g., trends, competitors, compliance landscape, and regulatory environment)
Strong expertise in health informatics, including familiarity with health outcomes databases, clinical trial registries Understanding of IT resource and cost drivers for a franchise or business unit
Knowledge of medical, legal, and ethical issues regarding management of the privacy for medical data sets
Participate/lead critical projects that may be matrixed, cross-functional, and/or global in nature
Anticipate business needs to influence the development of solutions
Lead the formulation of innovative ideas and solutions on products, processes, and systems
Manage vendors necessary to complete a project
Partner with scientists and clinicians to assist in the design and interpretation of new experiments and studies as needed
A Bachelor’s degree in Statistics or related discipline with a minimum of 10 years of relevant experience OR an advanced degree (Master’s or PhD) in Statistics or related discipline with a minimum of 5 years of relevant experience is required
Familiarity with tools and methods to calculate re-identification risk in clinical data is preferred
Experience building population statistics to compare to the prevalence of elements in the analysis dataset is preferred
Candidate must possess the ability to document findings and applied methods with both detail and accuracy. Experience working with complex, multidisciplinary teams in a matrix environment is required
Strong data modelling and schema design experience and working knowledge of relational database modeling concepts and SQL is required
Experience using data profiling / quality tools, experience with ETL activities, knowledge of common data models (e.g. OMOP, i2b2) is preferred
Understanding of clinical data model/standards/vocabularies such as MEDRA, SNOMED, CDISC, CDM and RxNORM is preferred
Experience working in a data warehouse environment with exposure to INFORMATICA, Redshift and Teradata, and knowledge of health outcomes databases (claim, EMR/EHR, survey, observation studies) is preferred
Experience working with contractors is preferred
Excellent interpersonal skills and able to drive tasks in a diverse team is required.Info Technology

Principal Scientist, SAS Programming, R&D Resume Examples & Samples

Contribute to the development of solutions for support across therapeutic areas, in the Asia/Pacific region, and across geographic regions
Support programming activities for clinical trials, including activities related to data management, statistical analysis, and reporting activities. Provide oversight of programming activities at the project level
Ensure all SAS Programming activities are conducted in accordance with high ethical and quality standards, all applicable GCP regulations, and company procedures
Effective collaboration in cross-functional teamsR&D

Principal Scientist Resume Examples & Samples

M.S. degree in analytical chemistry, biochemistry, biotechnology, or a related field with at least 10 years of relevant experience OR a Ph.D in analytical chemistry, biochemistry, biotechnology, or a related field with at least 5 years of relevant experience is required
In-depth experience with analytical method development for cell and/or gene therapy product is preferred
Experience in CAR-T cells, embryonic or induced pluripotent stem cells, umbilical vein endothelial cells characterization are preferred
High Content Imaging Platform that offers cellular imaging capability including, but not limited to, development and optimization of applications related to gene or cell therapy products is preferred
Direct experiences with operation of flow cytometry systems and/or nucleic acid assays are required
Project management skill is preferred
Experience working in a GLP/GMP environment is required
Experience maintaining laboratory notebooks and prepare written protocols and reports in a GMP compliant manner is required
Experience writing analytical sections of regulatory submissions and supporting regulatory filings including INDs and BLAs are preferredR&D

Principal Scientist Ad-smmd Resume Examples & Samples

You hold an advanced scientific degree (PhD) with at least 5 years of relevant experience (post graduate education and post graduate research experience will count towards the years of experience) or at the minimum a Masters’ degree in Chemistry or Biochemistry or related scientific field, with at least 10 years of relevant experience
In-depth knowledge of analytical method development/validation/transfer in support of API process research, in-process controls and GMP testing of chemical raw materials, intermediates and API is required
In-depth technical knowledge and high level of technical proficiency of different (instrumental) analytical techniques (e.g. separation science -LC, GC, IC, wet chemistry –titrations, specific optical rotation, UV spectroscopy- and spectrometric characterization techniques LC-MS(/MS), GC-MS/MS)) is required
Previous experience in working in a global and/or matrix organization and collaboration with external partners (e.g. contract research organizations, academics) is a plus

Principal Scientist Resume Examples & Samples

Effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/ or teams and work effectively with internal and external stakeholders
Plan, conduct and direct research and development
Prioritize tasks and manage a varied workload, exhibit strong written and verbal communication skills and interface effectively with project teams, management and surgeons
Develop creative solutions to solve problems
Demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively
Work independently solving technical problems with creative solutions, identifying all critical aspects of a design is required
Present opportunities to senior management, gain alignment on funding and deliverables
Establish, execute, and report on funded product development deliverables, taking project from concept, clinical program to commercialization either through internal team or external partners
Present and participate in portfolio strategy discussions
Develop a strong understanding of competitive, technology and IP landscape
A minimum of a Bachelor’s degree with 10 years experience (leading projects from concept to launch) OR a Master’s Degree in Engineering with a minimum of 6 years experience OR PhD with a minimum of 3 years experience is required
A focused degree in Polymers, Biology, Biomedical, Chemical Engineering, Biomaterials Engineering or Materials Science is preferred
Experience in medical device or pharmaceutical industry is preferred
Experience in a regulated industry is required
Knowledge of vitro tissue culture, biomechanics, cGMP or in vivo/preclinical musculoskeletal models is strongly preferred
Familiar with disease states as well as have direct experience in evaluating cell- scaffold (polymeric or biologic based) interactions, drug formulations, and/or design of preclinical studies is strongly preferred
Experience with advanced technologies, cell based therapies, bioactives, drugs, and/or scaffold based technologies for use in musculoskeletal tissue repair is required
Experience with process development and validation activities leading to manufacturing scale-up of pre-clinical toxicology supplies and pilot phase clinical manufacturing scale up is strongly preferred
Ability to look beyond conventional solutions and familiarity with technologies extending beyond traditional orthopedic therapies and products is strongly preferred
Excellent verbal, written and presentation skills, with experience presenting before a management board, are required
Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required.R&D

Principal Scientist, Process Development Lead Resume Examples & Samples

A minimum of a Bachelors degree with 6 years or a Masters degree with 4 years of industrial experience in a cGMP environment
A degree in Chemical Engineering or related field of study is preferred
Technical writing experience required

Principal Scientist Resume Examples & Samples

A minimum of bachelors degree in Psychology, Statistics, Food Science, Market Research, Biology, Chemistry, or related field is required
Minimum of 4 years relevant industry experience is required
Strong communication and leadership skills required
Experience partnering with and influencing cross-functional teams is required
Ability to function independently and problem solve required
Strong knowledge of statistical analysis methods for sensory/consumer research is required
Experience with variety of consumer research methods is required along with good knowledge of appropriate application of descriptive analysis and difference/discrimination methodsR&D

Principal Scientist / Scientific Integrator Resume Examples & Samples

Keeps abreast of current scientific developments and new techniques by reading the current scientific literature broadly, and by interacting with outside scientists. Pro-actively applies literature searches to current projects and to the development of new ideas. Consults on technical and conceptual planes with colleagues in PDMS
Trains and directs laboratory personnel. Delegates work assignments effectively. Evaluates performance of personnel. Plans developmental opportunities for personnel to increase efficiency, encourage job satisfaction and personal growth, and enhance professionalism. Strives with supervisee(s) to achieve: performance management; a fair framework of recognition and reward; fairness and a mature sense of discipline; open communication; and mutual respect
Takes an active role in discussions at research meetings, thereby sharing information, knowledge, ideas, and judgement to help establish valid scientific directions
Assumes a scientific leadership role in PDMS; applies this to scientific endeavours and to the advancement of projects
Endeavours to establish a scientific reputation through scientific accomplishments directed toward the development of therapeutic agents for PDMS, including publishing work in journals, participating in patent preparation, oral presentations, and participating in professional societies
Ensures that new inventions and discoveries are properly documented as evidence of invention and reduction to practice
Ensures that work adheres to established operating procedures and safety regulations adhering to company work standards
Performs in multiple roles, e.g. leading at Technical Integrator and/or Chemistry Lead (role description attached) in more than one project at more than one stage of development. May be called upon performing the roles of Single Point of Contact and/or Group Leader (role description attached)

Principal Scientist Resume Examples & Samples

Candidates should have a PhD in Neuroscience or related discipline and at least 10-15 years of research experience, preferably on Alzheimer’s disease
The candidate will have state-of-the-art knowledge in histological, histochemical, autoradiographical and other imaging techniques (e.g. multiplex immunofluorescence, PET, etc.) and will be the point of contact in these disciplines
Have demonstrated experience of directing research independently and an excellent publication record
The successful applicant should possess proven skills in laboratory staff management and be a team player
Experience within the pharmaceutical industry and of leading drug discovery projects is considered a major advantage
Have the ability to operate within a multidisciplinary team
Excellent communication and organizational skillsBiology

Principal Scientist, Separation Sciences Resume Examples & Samples

Lead separation method development and validation activities for assigned projects in Separation Sciences
Lead a cross-functional analytical team consisting of members from each of the analytical sub-functions for an assigned project
Interact with various stakeholders including Commercial Manufacturing, Regulatory, Quality, Discovery, and external partners
Additional responsibilities include method transfers to commercial sites, analytical control strategy, justification of specifications, and criticality analysis
Ph.D. in Biochemistry, Analytical Chemistry, or related discipline with at least 5 years of experience in biopharmaceutical development OR a M.S. degree with at least 10 years of experience in biopharmaceutical development is required
At least 3 years of experience working on cross-functional CMC teams is required
In-depth large molecule Analytical Development experience with focus on Separation methods such as HPLC and capillary electrophoresis techniques is required
Previous experience writing regulatory filings is preferred

Principal Scientist Resume Examples & Samples

Job title: Principal Scientist Asia Clinical Supplies, Pharma Development & Manufacturing Sciences (PDMS)
Sector: Pharmaceutical
Location: Seoul, Korea or China or India
Process- and SHE-integrated approach (V-model, IQ, OQ, PQ, Cleaning Validation, Safety analysis…)
Setup of the required cross-linked information platforms (QA, Manufacturing, Prevention, PDMS/JSC…)
Review Master Service Agreement and define Scope of Work at CMO
Define and follow-up on project, FTE and budget planning
Follow-up on orders and invoicing according to project plan
Periodic review and score card monitoring of CMO’s
He/she has strong responsibility with respect to the dedicated operational and project budget. He will have full control of budget and cost during project realization in order to fulfill the financial restrictions
He/she will draw from a (global) project team with members out of different disciplines and with different functions that have their contribution to the project realization. The management of this team must lead to the required performances in order to realize the project objectives
Must be able to work with Contract Manufacturing Organizations to perform capability assessments and provide technical expertise to influence and bridge gap analysis to meet Clinical Trial Material requirements
For small as well as for large projects, extensive contacts with different suppliers/contractors can be necessary in order to achieve the required project results. This means mutual exchange of information e.g. managing confidentiality agreements, applicable internal standards, user & process specifications, functional specifications and product information
Benchmarking and updating internal knowledge means contact with and information exchanges with other pharmaceutical companies during workshops, seminars…
Knowledge in sterilization technology and parenteral processes including fill/finish is required, 차-부장급
Knowledge in large molecule drug substance process development and manufacturing
Specific expertise: Clinical Manufacturing, Process Engineering & Scale-up
Elementary technical background (mechanics, electrical, PLC, …)
Preferably Chemical, Mechanical or Pharmaceutical Process Engineering degree or equivalent with at least 10 years in pharmaceutical area
GXP, Regulatory requirements, J&J / JPh-standards & guidelines, applicable Standard Operating Procedures, Engineering Technical Standards, Technical Safety Standards, Industrial Hygiene Standards, MS office applications …
Excellent knowledge of English (spoken and written)
Willing to travel (up to 50%)

Principal Scientist, Data Sciences Resume Examples & Samples

M.D. or Ph.D. degree in Computer Sciences, Statistics, Machine Learning & Artificial Intelligence, Molecular Biology, Bioinformatics, Computational Informatics, Medical Informatics, Computational Biology or a related discipline is required
A minimum of 7 years of industry or postdoctoral experience is required
Strong understanding of drug discovery and development processes is preferred
Experience with informatics, analysis and visualization software/tools such as R/Bioconductor, Knime, Pipeline Pilot, Spotfire, GenePattern, MatLab, SAS or other analytical tools is required

Principal Scientist, Thrombosis Resume Examples & Samples

He/she will be handling various in vivo experiments, including dosing and performing surgical procedures
This person will be designing, conducting and critically evaluating antithrombotic activity of novel agents in various models including the AV-shunt and ferric chloride models of thrombosis
The Scientist will have the ability to perform acute and chronic bleeding assessments in various models including gastrointestinal bleeding is essential
The incumbent will supervise and mentor scientists in the lab. He she will participate and present data at project and departmental meetings
This person will interact with colleagues from chemistry, discovery sciences, toxicology and clinical groups. He/she will initiate and manage collaborations/studies with academic groups and CRO’s
This person will write study reports for internal documents and for regulatory submissions. This person will write manuscripts for publication in scientific journals, abstracts for scientific meetings, participate and present data at external scientific meetings
BS/MS degree in life sciences or related field with at least 12 years of experience in pharmaceutical, biotechnology, or academic experience OR PhD/MD degree in life sciences or related field with at least 8 years of experience in pharmaceutical, biotechnology or related industry is required
Expertise in thrombosis research is required
Previous industry experience is required
Experience in handling various in vivo models is required
Experience working in a multi-disciplinary, highly matrix environment is required
Experience as a team leader within a matrix team, both as a team member and a team leader is required
In-depth experience and knowledge of the drug discovery and early development process is required.R&D

Principal Scientist, Thrombosis Resume Examples & Samples

Expertise and hands on experience in blood coagulation (aPTT, PT, TT) and platelet function tests (p-selectin expression, platelet aggregation) is critical
This individual will perform thrombin generation assay and thromboelastography assay
The role will establish and critically evaluate target engagement assays and novel biomarkers for antithrombotic efficacy and bleeding
Supervise and mentor scientists in the lab
Participate and present data at project and departmental meetings
Interact with colleagues from chemistry, discovery sciences, toxicology and clinical groups
Initiate and manage collaborations/studies with academic groups and CRO’s
Write study reports for internal documents and for regulatory submissions
Write manuscripts for publication in scientific journals, abstracts for scientific meetings, participate and present data at external scientific meetings
Extensive interactions discovery sciences group
Interactions with biologists and chemists in CVM
BS/MS degree in life sciences or related field with at least 12 years of experience in pharmaceutical, biotechnology, or academic experience OR a PhD/MD degree in life sciences or related field with at least 8 years of experience in pharmaceutical, biotechnology or related industry is required
Background in biochemistry and enzymology of the blood clotting (intrinsic and extrinsic coagulation cascade) is required
In-depth experience and knowledge of the drug discovery and early development process is required
This role requires individual to be in the lab up to 70%R&D

Principal Scientist Beverage Ingredient Discovery Resume Examples & Samples

PhD./Masters in Chemistry, Food Science or a related field (preferred) with 5-year experience in flavor chemistry and reaction flavors
Knowledge of sensory and analytical chemistry is a plus. Must possess strong interpersonal and communication skills demonstrated by the ability to positively influence others. Demonstrated ability to manage priorities and multi-task
Excellent communication skills (verbal and written)
Excellent data management, lab notebook maintenance and organizational skills
Technical background in flavor chemistry, soft chemistry, reaction flavors
Working knowledge of flavor regulation and natural labeling
Effective team player

R&D Principal Scientist Resume Examples & Samples

Identify and validate new ingredients and technologies
Develop ingredient delivery systems to address solubility, taste and stability concerns
Leverage experimental designs to develop robust sensory and analytical test protocols for new ingredients or compounds
Effectively communicate technical findings through presentations, publications, or patents
Effectively protect intellectual property
Ph.D degree in Chemistry, Biochemistry or Food Science with 5+ years experience in Academia or Industry
Experience working effectively as a member and contributor in cross functional teams
Experience and track record in patents and IP strategy
Ready to Drink Beverage experience a plus

R&D Fsra Principal Scientist Resume Examples & Samples

Minimum 6 years' of regulatory experience with a strong preference for 4 years in the Food Industry
Demonstrated influencing skills coupled with the ability to understand project needs and translate them into regulatory roadmaps / advise
Broad knowledge of Global Food Regulations with a desired in-depth knowledge in US and EU and beverages
Ability to review available data sources and distill information to meet business asks

Principal Scientist Resume Examples & Samples

Lead in New Product/ Technology Transfer, Cost Improvement projects & Reformulation Project. Ensure all project are well defined and planned, documented and ensure execution in manner meeting GMP, health, Safety and Environmental and corporate quality standards
To render technical support to R&D team on New Product Development (NPD) project by involving in formulation review and process design for manufacturing scale up at IHI
To collaborate effectively with NPD cross-functional teams within AP region
Execute product technology transfer and new product launches as per NPD Road Map and project timeline. Ensure completeness of documentation as per APR requirements on timely basis
Execute process development and qualification activities in mixing process, cleaning process, new process technologies. Provide technical training and transfer of knowledge on processes to users
Conduct technical trouble shooting for product formulation, mixing and cleaning processes which include product first pass yield, mixing and cleaning improvement program, non-conformance investigation and root cause analysis, with the use of PE tools
To review and coordinate product stability for product, raw material and process qualification as well as formulation under technology transfer
To identify areas for improvement and drive flawless execution in project assignment by using Process Excellent tools e.g. Design of experiment, Lean thinking and Six-sigma process and FPX (Flawless Project Execution) methodology
Take initiative to continuously enhance technical expertise in formulation, mixing process and raw materials knowledge through self-initiative & -learning, networking with cross-functional team / cross-country teams, on-the-job exposures and interactive sharing of knowledge among team members
To identify and apply the LEAN opportunities in project deployment and work approach
2-5 years experience in the field of pharmaceutical or related industry
Experience in NPD, Tech Transfer and RM qualification of OTC products
Good communication skills for effective liaison and teamwork in a dynamic/highly collaborative environment. English proficiency is required
Knowledge of BPOM guidelines with some working experience in GMP environment
Proactive, has sense of urgency and able to work effectively in a team as well as independently with minimum supervision
Strong leadership Skills
Good problem solving skills and analytical skills
Computer literate, proficient with Microsoft Office applications

Principal Scientist Resume Examples & Samples

Provide scientific leadership to a team that (1) develops assays in cell based formats that are suitable for automated high-throughput screening in 384 or 1536-well formats (2) executes high-throughput screens (3) analyzes screening data including presentation at program team meetings. A level of hands-on laboratory work is expected
Provide mentoring and career development leadership to direct reports and to others within the department as appropriate
Collaborate across multiple therapeutic and functional areas in the US, Europe and Asia
Develop innovative approaches to screening and hit triage
Manage external collaborations
Publish research in high-quality journals as appropriate
PhD and postdoctoral experience in biochemistry, cell biology or molecular pharmacology or related areas with at least 8 years of industry experience in cell-based assay development for pharmacology and high-throughput screening is required
Demonstrated ability to lead and develop a team is required
Expertise with cell-based assays is required
Expertise with 3D cell culture is desired
Experience working with and guiding external collaborators in industry or academia is desiredR&D

Principal Scientist Resume Examples & Samples

Perform studies using cellular (e.g., podocytes) models related to kidney function
Optimize preclinical kidney-disease models for reproducibility, robustness and signal to noise ratio
Lead biology efforts supporting target identification and optimization for drug discovery programs in chronic and diabetic kidney diseases
A PhD or MD/PhD with at least 7 years of combined industrial/postdoctoral experience is required
Working knowledge of chronic and diabetic kidney diseases and processes and mechanisms leading to kidney failure is required
Knowledge in renal physiology and etiology of chronic kidney disease is required
Demonstrated understanding and established level of expertise evaluating preclinical models of kidney disease is required
Demonstrated ability to work in the lab with kidney derived cells and tissue is required
Established expertise working with in vivo models of chronic kidney disease is required

Principal Scientist / Engineer Resume Examples & Samples

Bachelor’s degree in Science/ Engineering or equivalent is required
8-10+ years’ experience in multi-disciplined science/engineering environment with experience in manufacturing commercialization is required
Complete understanding and application of principles, concepts and practices of processes and manufacturing equipment is required
Strong statistical basis such as Process & Design Excellence skills is required
Hands-on Project Management leadership style with strong interpersonal and organizational skills is required
Experience in a Cross Functional Team Environment taking new products from concept to launch is preferred

Principal Scientist Resume Examples & Samples

Work with Analytical Scientific Integrators to develop project workflow and timelines and ensure project deliverables are met with high quality and on time
Extensive interactions with multidisciplinary and multi-site groups, which may include external vendors and/or strategic suppliers
Support Analytical projects within the CMC Organization and will interface with key stakeholders for critical analytical projects for small molecules
Ensure participation and focused progress of Analytical development groups/projects and other involved CMC functions and facilities
Support strategy in a flexible global organization to meet regional customer requirements in EMEA, Asia Pac and US
Ensure products, processes, and supporting methods are aligned with strategic technical platforms for analytical methodologies
Ensure design alignment with customer needs, early to late development and manufacturing for small molecules
Core member of analytical development team, with key interactions with Scientific Integrators and other department leaders, technical groups, regulatory organizations, quality, & external partners
Serve on development teams supporting major and/or minor filings for new products
Able to support writing of lab events, amendments, investigations, agency responses, and other submissions
MS Degree in Chemistry, Pharmacy, or equivalent life sciences degree with at least 10 years pharmaceutical industry experience OR a PhD with at least 8 years pharmaceutical industry experience is required
Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development/commercialization process is required
Demonstrated knowledge of analytical or biochemistry in a R&D and cGMP environment is required
Demonstrated leadership/supervisory skills including working in a matrixed environment is required
Extensive knowledge and background in chromatographic techniques and HPLC is required; UHPLC is preferred
Experience with method development and method validation are preferred
Small molecule experience is required; Biologics is preferredR&D

Principal Scientist Resume Examples & Samples

Serve as technical expert in the microbial pathogenesis and related virulence factors in animal or clinical trial protocols
Serve as technical expert in the development of nucleic acid and immunoassay diagnostic tests
Serve as technical expert in the research and development of novel medical countermeasures to detect; diagnose; and mitigate wound infections. c. Minimum qualifications; a Ph.D. in Microbiology; Immunology; Molecular Biology; Biochemistry or other related scientific field; or an M.D. d. Minimum experience: experience beyond Ph.D. Preclinical (i.e. animal) research experience in wound infections is required. e. Draft research protocols and grant proposals for scientific review and conduct the approved research. f. Observe; instruct and validate technician performance. g. Keep accurate and complete records of research done in accordance with QASP and contract requirements to include modifications. h. Submit reports and data summaries as requested and prepare research results for presentation and publication in the scientific literature. i. Comply with occupational health and safety standards and other applicable regulations and guidelines which may include medical surveillance. j. Attend and participate in seminars; scientific conferences; and meetings; as required. k. Alternative Bacterial Disease Branch collateral duty officer in accordance with Safety Office and other applicable guidelines; as required

Principal Scientist Resume Examples & Samples

Possession of a Doctoral degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) appropriate to biomedical research
A minimum of eight (8) years of post-graduate experience including five (5) years of independent, competent, and innovative research in a field of specialty. Three (3) or more years of managerial experience
Demonstrated experience in: flow cytometry, including use of Diva and FlowJo software, molecular biology, T-cell immunology, performing experiments with mice and murine models
PhD in immunology
Experience with CRISPR technology

Sediment Transport Principal Scientist Resume Examples & Samples

M.S. or Ph.D. in Civil or Environmental Engineering, Earth Sciences, Hydrodynamics, Marine Geology, Oceanography, or similar discipline
Fifteen (or more) years of experience in environmental consulting or part-time consulting from an academic position
An outstanding reputation among clients for integrity, responsiveness, and technical expertise
Experience as an expert witness

Principal Scientist Resume Examples & Samples

In-depth knowledge of measurement principles and benefit/limitation of common material characterization techniques for nanoparticles and surface properties
Proven capability to develop new concept into validated testing methods, experienced in designing/building new or improving existing measurement tools is preferred
A track record of scientific productivity and innovation as evidenced by high quality publications, patents, or commercialized products
Experience in project management principles and practice is a plus
Experience with statistical data analysis is a plus
Comprehensive knowledge in physical chemistry and material interactions at nano-scale
Srong written and oral communication skills
Highly creative and self-motivated
Ph.D. in polymer physics, or physical chemistry, or material science, or analytical chemistry, or chemical engineering
5+ years of experience working in an industrial environment
3+ years of extensive hands-on laboratory experience encompassing characterizing physical/structural/chemical properties of materials, such as nanoparticles, surface adsorption, porous material, etc. using common material characterization techniques (microscopy, spectroscopy, performance testing, etc.)

Principal Scientist / Engineer Resume Examples & Samples

Integrate purification technologies with single-use technologies to create process solutions
Conduct feasibility assessments utilizing SUT and continuous processing systems coupled with Pall’s purification technologies including chromatography, tangential flow filtration (TFF), depth filtration, and direct flow filtration (DFF) for unit operations from cell harvest through fill / finish
Maintain close customer contact during all projects. This will involve travel to customer sites (majority domestic) for technical meetings or to perform test work, giving technical presentations, and updating customers on project status
Technical consultation involving scale up/scale down testing plans and data review, sizing and compatibility recommendations, and troubleshooting customer technical issues and field investigations
Provide “voice of customer” feedback through regular communication with other Pall groups (Marketing, Applications R&D, other SLS teams)
Maintain an up-to-date knowledge of current regulatory trends, issues and guidelines relating to the products being supported
Chemical engineering degree or an MS degree with an engineering discipline
Good interpersonal, relationship-building and technical presentation skills
Ability to work with and communicate effectively with process development scientists (based at our Strategic Accounts)
Experience to include chromatographic separations, protein purification, continuous processing, single-use technology (SUT) systems operations, hands-on equipment knowledge and the ability to create recipes for systems
Working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel)

Principal Scientist Resume Examples & Samples

Develop, validate and implement new methods by providing technical leadership Translate problems into R&D objectives; specify requirements; investigate options (based on technical complexity and cost); solve problems, meet deliverables
Work with cross-functional team to deliver breakthrough technologies
Design and development of methods of inclusion of new surface modification into membranes and filters
Optimize and scale-up of successful candidates
Maintain thorough knowledge of state-of-the-art in polymer chemistries, surface modification and coating techniques
Work closely with manufacturing and development groups in technology transfer and components change
Ph.D. in chemistry, physical/chemistry, polymer chemistry, polymer science, materials science or in chemical engineering
3+ years’ experience in analytical chemistry
3+ years’ knowledge of various resin chemistries (modification with specific functionality) and waterborne polymers
3+ years’ scientific productivity as evidenced by high quality publications and/or patents and/or commercialized products
5+ years’ experience in polymer science/chemistry
5+ years’ experience in polymers modification and characterization. 5+ years’ experience in the polymer industry
5+ years’ experience with all common characterization techniques (NMR, UV-VIS, SEM, TEM, Rheometer, FT-IR, GPC, DMA, DSC, TGA, LS/DLS, Small Angle Scattering, etc.)
Knowledge in surface modification (coating and grafting) of thin films
Broad expertise in polymeric materials characterization (solid and solution phase)
Experience with surface modification of nano- / micro-inorganic and organic particles are a plus
Knowledge of polymerization techniques is a plus
Experience with D.O.E. and scale-up a plus

Principal Scientist Resume Examples & Samples

Project Management: drive projects forward, effectively communicate status and results
Technical expertise: use current knowledge to advise on, design, and execute project plans. When necessary actively acquire additional knowledge to accomplish these tasks
Presentations: internal and external presentations, including results summaries and training of others
Industry experience required
Experience optimizing cell cultures utilizing bioreactors, (preferably in the area of mammalian cell culture process development)
Ability to manage complex project with minimal supervision
Master's Degree in Biological Science, Chemical Engineering or related field with seven years experience or a Ph.D. in related field with five or more years of experience

Principal Scientist Resume Examples & Samples

Leads/oversees technical development activities of an assay development team, maintains detailed project development schedule, and is accountable for timely delivery of technical milestones for a diagnostic/assay development project
Oversees studies and assigns specific projects to subordinates; establishes target dates and priorities. Coordinates study activities with intra- and interdisciplinary departmental groups
Effectively impacts collaborations by leading activities across functional sites/areas; manages and resolve issues with external collaborations and vendors if needed
Accountable for identifying and completion of all technical documents required for various stages of product development and for regulatory submissions
Manages lab/assigned area and assures quality of raw data according to the appropriate SOP, GLP, GMP guidelines in compliance with Novartis guidelines
Extensive and in‐depth knowledge of scientific discipline

Principal Scientist Resume Examples & Samples

Bachelor's Degree in either Electrical Engineering or Computer Engineering
7+ years' experience in applied research or advanced development with Bachelor's degree
5+ years' experience in applied research or advanced development with Master’s degree
Advanced degree (PhD) and 5 years of experience strongly preferred
Educational focus in electrosurgery and electrosurgical systems, or related field
Extensive hands-on research and/or product development experience with complex devices and systems, and their electrical, thermal and mechanical characterization
Excellent research and reasoning skills that encompass originality (to develop creative ways to solve a problem), deductive reasoning skills (to apply general rules to specific problems to produce answers that make sense), and fluency of ideas (to express multiple solutions)
Competence with typical electronic measurement equipment such as oscilloscopes, spectrum analyzers, function generators, etc
Familiar with basic electrosurgical system design, relevant safety standards, and algorithms and techniques used to regulate RF output
Strong written and oral communication skills with the ability to communicate information and ideas in writing so that others will understand
Understanding of plasma physics (preferably as applied to electrosurgical devices and generators)
Medical device industry experience
Experience with Matlab and Labview
Must be capable of working without appreciable direction and will have considerable latitude in determining technical objectives of assignment(s)
Ability to provide leadership and guidance to others in the group
Ability to handle multiple tasks/projects and manage priorities accordingly

Principal Scientist Resume Examples & Samples

Experience in managing nonclinical safety studies at external facilities
Strong computer and general software skills; familiarity with Documentum preferred
Strong oral/written communication skills

Principal Scientist Antibody Drug Conjugates Preformulation Resume Examples & Samples

Conceive, execute and communicate novel multi-disciplinary strategies to drive development of innovative ADC drug candidates with fit for purpose drug like properties
Design, execute and document scientific experiments for the preformulation assessment of ADCs to facilitate formulation development activities
Lead and execute scientific projects, generating original technical ideas for formulation and analytical technologies
Interact and influence cross-functional teams to establish productive collaborations within and outside of AbbVie
Provide effective leadership to scientists in a matrix structure generating technically innovative delivery concepts

Principal Scientist, Dmpk Resume Examples & Samples

Work closely with project leaders, Research & Development, Toxicology, Regulatory, and Clinical in order to develop an overall ADME/DMPK development plan that supports appropriate selection and efficient transition of candidate molecules into Phase I-II-III clinical trials
Responsible for ADME & DMPK studies for all products under nonclinical development. This includes direct interface with the contract research organizations (CROs) to provide input during protocol development phase, derive cost estimates, timelines, study protocols and reports, as well as monitoring study activities
Maintain a robust network of ADME/DMPK CRO and consultant relationships to ensure scalable and flexible support capacity to respond to program needs at all stages of development
Review nonclinical study proposals and ensure that they fulfill all requirements of the program development plan
Develop appropriate strategies for risk assessment of lead molecules including PK/PD, metabolism, and drug-drug interactions
Develop submissions for INDs and/or NCOs, IBs, and NDAs
Critically assess the analysis and interpretation of study outcomes and review and edit study reports
Maintain a current understanding of DMPK literature, methodology and regulatory requirements
Support ongoing toxicology activities across Akebia portfolio (investigative efforts, impurity assessments, CRO selection, protocol development, study monitoring and data interpretation) expanding and deepening Akebia capabilities within the nonclinical space
Ph.D. in Pharmacology, Pharmacokinetics, Toxicology or closely related discipline
At least 5 years of DMPK experience in the Biotech-Pharma industry, proficient in small molecule drug development
Experience in designing, monitoring, and interpreting ADME/DMPK studies with familiarity/desire to expand into a supporting toxicology role
Record in developing submissions for INDs and/or NCOs, IBs, and NDAs, and with experience interfacing directly with regulatory teams and agencies

Principal Scientist, Bioanalysis Resume Examples & Samples

Contract and monitor new pharmacodynamics/ PGx and other assay methods under limited supervision
Advising R&D functions (eg. Clinical, regulatory, legal, commercial, business development) as an expert in all PD related aspects
Collaborate with clinical development teams, responsible to deliver PD/ Exploratory biomarker sections of clinical trial protocols, informed consent forms, lab manuals and any additional communications to regulatory bodies, IRBs or others stakeholders
Monitor bioanalytical method validation work following the protocol, SOPs and FDA guidance
Select appropriate service labs to support PD activities, as well as monitor PGx sample collection, handling and storage in collaboration with Clinical Development Operations and the CROs
Perform bioanalytical sample analysis for clinical trials in a regulated environment
Project management with CROs and clinical development core teams
Evaluate/ assist in preparation of method validation and sample assay reports
Experience with NGS Bioinformatic analysis software a plus
Other relevant responsibilities as assigned
Ph.D. in Molecular biology or biological sciences or equivalent with 2+ years of related experience; M.S. with 8+ years of related experience
Knowledge and experience with advanced methods in pharmacogenomics, such as arrays and NGS
Knowledge and experience in the performance and validation of ligand binding assays (ELISA)
Knowledge of FDA guideline for bioanalytical method validation
Working knowledge of SOPs and GLP regulatory guidance
Knowledge of computer software for laboratory data management
Skills in conducting bioanalytical research especially for running clinical samples, documenting data, and assisting report writing following the regulatory requirements
Self-motivated, excellent team player with good communication skills
LI-BR

Principal Scientist Resume Examples & Samples

Independently develops pre-clinical PK/PD and quantitative systems pharmacology models that enhance decision making and inform translational research strategy for NBEs
Uses modeling and simulation to predict human efficacious dose/dose regimen, and influences selection of first-in-human starting dose
Designs, analyzes and interprets data and communicates results to teams and management
Leverages literature data or proposes new experiments to validate models or test model-generated hypotheses
Develops new methodologies, protocols or procedures that contribute to core group/research goals and reflect expert knowledge
PK/PD modeling representative on multiple cross-functional project teams
Effectively collaborates with scientists within and outside functional area
Prepares clear technical reports, publications and oral presentations
Develops broad knowledge in field of expertise and enhances internal capabilities of group
Presents work at internal/external scientific meetings and publishes work in scientific journals

Principal Scientist / Associate Director Resume Examples & Samples

MD , PhD, or equivalent advanced biology degree
Experienced scientist with 6+ years of experience in the drug development process
Significant understanding of the role of translational research/medicine and clinical biomarkers in drug development
Demonstrated knowledge of oncology and/or tumor-immunology disease biology
Demonstrated working knowledge of the concepts of flow cytometry, various genomic profiling technologies, systems biology, immuno-assays, qRT-PCR, cell culture, and other basic molecular and cell biology methods
Significant understanding of all functional areas of drug development, including, biology, toxicology, clinical development, diagnostic development, etc
Demonstrated ability to work in a matrix environment
Ability to multitask across multiple development assets
1600785

Principal Scientist Resume Examples & Samples

Develop and execute laboratory workplans/schedules for self and team, using customer milestones and Division/site performance standards and metrics
Review technical documents for accuracy, thoroughness and compliance
Responsible as project director on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business
Identifies and independently drives department level improvements
Support development of business strategies for multiple customers across multiple company sites
Bachelor's degree with 12 - 15 +years related experience
Master's degree with 9 - 15 years related experience
Doctorate Degree 5 – 12 years related experience
Advanced project management skills are routinely practiced for multiple concurrent projects of moderate to high complexity
Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones
Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings
Provides reliable/defendable interpretations of regulatory guidances for the customer and is capable of defending these positions to regulatory agencies
Mathematical and scientific reasoning ability
Capable of rapidly learning multiple unfamiliar principles or techniques with minimum training
Well organized with ability to handle and direct multiple activities simultaneously
Ability to communicate complex technical information to non-technical audiences
Able to lead difficult discussions with customers and drive the to an acceptable resolution
May be accountable to meet business unit revenue targets
Leadership development skills are expected
Proactively identifies and implements new technologies and understands their impact on Catalent offerings
Recognized by internal/external customers as subject matter expert with high credibility
Excellent motivator, well versed in team development
Work with Business Development to win new business (conference calls, customer meetings, travel)
Understand the details of regulatory CMC filing package and analytical and formulation documentation required. Has the ability to write and review documents for regualtory filings

Principal Scientist, Computational Biology Resume Examples & Samples

Computational mapping between chemical and protein structure, biochemical effects mediated via perturbation of the ubiquitin proteosome system, and meaningful therapeutic outcomes in key indications
Pursuit and supervision of leading computational biology research towards key Celgene scientific objectives, including line management of junior staff
Active participation as a core team member in the Protein Homeostasis Thematic Center of Excellence (TCoE)
Coordinated application of novel computational analysis and biological interpretation approaches to leverage internal, public and partner datasets and empower data-driven decisions across therapeutic programs
Multi-disciplinary collaboration to investigate compound and disease properties and influence decisions from target prioritization through to translational development
Data integration across assay platforms and knowledge transfer between pre-clinical experiments and clinical trials
Participation in and oversight of scientific report writing. Presentation of methods, results and conclusions to a publishable standard
LI-JW1
7+ years post-doctoral experience of inter-disciplinary computational and molecular/chemical biology research in university, hospital or biotechnology environments
Strong knowledge of post-translational modification, wider proteasomal and immune mechanisms preferable
Good knowledge of cheminformatics and/or structural biology approaches desirable. Familiarity with proteome-wide mass-spectrometry studies prerequisite, alongside ability to design and apply methods to mine public structural and genetic databases
Previous experience of research supervision and track record of peer-reviewed publication in relevant scientific journals

Principal Scientist, Exploratory Toxicology Resume Examples & Samples

Design and conduct in vitro and molecular toxicology experiments focused on identification of mechanistic basis of toxicity
Evaluate and implement novel in vitro toxicology models and assays
Conduct and manage in vitro toxicology screening assays
Supervise and mentor scientific staff
Contribute to identification of early target safety risk based on projected mechanism of pharmaceutical action, literature knowledge on pathways and/or toxicological profile of competitor drugs
Maintain in vitro and molecular toxicology expertise through organizational associations, literature review, continuing education, and publications
Establish and maintain working relationship with key opinion leaders in the toxicology community, academicians, and key Celgene staff
Opportunity to serve as toxicology representative on Discovery Project Teams
LI-PRIORITY
PhD degree in toxicology or related field and 8+ years of work experience, with a focus on cellular, molecular and biochemical toxicology
Experience in drug development required
Management experience highly desirable
Advanced knowledge of general, cellular and molecular toxicology principles
Experience conducting mechanistic investigative studies involving signal transduction pathways, proteomics and genomics
Strong written and verbal communication skills and computer proficiency
Ability to work collaboratively with colleagues in other departments and project teams
American Board of Toxicology (DABT) certification preferred

Principal Scientist, Cellular Therapeutics Resume Examples & Samples

Provides leadership capability to project/project team, creates and tracks achievable goals for the team that are aligned with Corporate and Divisional Objectives, designs and carries out laboratory experiments for discovery, research and early development of immune-oncology projects
Develops scientific strategies, and accountable for project success and deliverables
Has direct impact on the performance of multiple departments through leading project teams and contributing to cross-functional teams
Provides in-depth analysis & interpretations of diverse experimental results
Serves as subject matter expert and functional group advisor on science, technology and methods
Independently designs and implements long-term project plans and appropriate experiments that define efficacy and mechanism of action of the cellular product via gene, protein and function-based in vitro assessments
Improves current functional assessment approaches by designing pertinent novel cell-based assays and/or cellular immune-based assays
Provide recommendations for, and implement studies and strategies to define the phenotypic and functional characteristics of the cellular product in pertinent in vivo studies
Supervise contract research organizations to achieve high standards of productivity and quality
Present work at project team/franchise team meetings, internal forums, and external meetings
Provide scientific progress reports to the Senior Director and/or Senior Management as required
Author and oversee writing of study reports, patents, and peer-reviewed publications. Presentation of methods, results and conclusions to publishable standards
Develops research staff through instruction, coaching and guidance

Principal Scientist Resume Examples & Samples

Design and execute experiments, using internal or outsourced resources as appropriate, to define and test hypotheses for selection of tumor type and patient characteristics for particular drugs, and drug combinations, including small molecules and biologics
Develop and/or characterize pre-clinical and clinical methods for measuring pharmacodynamic effects and surrogate markers for efficacy to guide determination of dose, schedule, and priority indications in clinical trials
Design and execute biomarker and correlative components of clinical trials, including participation on trial teams, management of vendors, analysis of data, and communication with study investigators and other stakeholders
Independently identify and manage collaboration relationships with leading academic investigators including both clinical trials and preclinical studies
Provide strategic and disease biology leadership to set science-driven, patient-focused priorities for development of the Celgene pipeline
Ph.D. with at least 8 years of relevant work experience, preferred
The ideal candidate will have a Ph.D. with up to 15 years of relevant pharmaceutical industry experience
Experience in industry and translational, biomarker work is preferred
Advanced, current knowledge of oncology including disease biology, treatment approaches, agents in development, and competitive landscape
Expert in molecular and cellular biology including concepts and pathways, and experimental methods such as cell culture and cell-based assays, FACS, ELISAs, Westerns, gene expression, si/shRNA/CRISPR, analyses of splice variants, and/or ex vivo immune cell assays
Exceptional interpersonal and communication skills
Ability to independently represent the science in interactions with clinical and thought leaders across multiple areas of oncology and ability to present to high-level audiences

Principal Scientist Resume Examples & Samples

Key contributor to translational science in the context of early-phase clinical trials
Lead the selection, validation, and deployment of novel clinical-stage assay methods and analysis of data to accelerate development and provide insight into disease biology and drug mechanisms
Design, execute and interpret experiments to define dose-schedules, patient selection markers and other biomarker readouts, combination strategies and pathways of drug resistance for oncology programs
Design and conduct experiments to test hypotheses from clinical observations in preclinical model systems
Present work at group meetings, internal forums and scientific conferences
Provide scientific leadership on cross-site and cross-functional teams
Contribute to the planning and execution of collaborative projects with leading academic and commercial research groups worldwide
Mentor other research staff through instruction, coaching and guidance
Expert in the development and application of NGS, omic, and other analysis methods that generate high-dimensional data
Experienced leader
Knowledge of cancer biology
Strong understanding, derived from direct participation, in the design and execution of clinical trials incorporating translational science and correlative endpoints
Expertise in biomarker discovery and development

Principal Scientist Resume Examples & Samples

Accountable for evaluation and execution of clinical biomarker assays in his/her field of expertise (e.g. Clinical Genomics, RNAseq, Nanostring, NGS, mass spectrometry, protein arrays, FACS, and ligand binding assay, etc.) with specific focus on “fit for purpose” regulated biomarker assay development, validation, transfer, implementation, sample testing
Contribute to biomarker & CDx testing and complex data analysis: closely collaborate with colleagues from multiple departments including clinical operations, translational medicine, biostatistics and bioinformatics etc. to design data analysis plans, interpret BM and CDx results for clinical decision-making
Act as subject matter expert (SME) and provide support in exploratory biomarker hypothesis testing & generation according to biomarker development plan(s). He/she will oversee the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers)
Proactively works across project teams and partner lines to perform scientific & technical review of novel biomarker technologies to build-up cutting edge biomarker/CDx capabilities with clinical application potential in supporting clinical BM and CDx efforts
Participate in preparation of dedicated biomarker study plan linked to a specific trial in close collaboration with CBD colleagues and other relevant functions
Contribute to preparation and update of biomarker prioritization lists in alignment with other relevant functions. Contribute to relevant biomarker/ CDx content in submission documents
Contribute to review of documents from his/her area of expertise for each specific trial (including but not limited to LSD, LES, CTP, CTP amendments)
Prepare requests for information (RFI), requests for proposal (RFP), scope of work (SOW) and other relevant necessary documents to support clinical outsourcing activities across project teams
Provide scientific and operational oversight of CROs and other ancillary vendors as appropriate to supervise CROs to achieve high standards of productivity and quality in supporting clinical BM/CDx outsourcing
Assist in development of CBD outsourcing strategies. Contribute to establish & standardize outsourcing practices/tools to support clinical studies and ensure adherence to company’s strategy, policies, goals and procedures
Collaborate with project lead and quality management etc. to ensure projects are conducted in accordance with SOPs, CLIA/CAP, GCP, GLP, and/or other regulatory guidance as appropriate
Be the key stakeholder in assigned internal and external collaborations
Contribute to outsourcing process, vendor management best practices and process improvements
Manage and/or oversee of budget, timelines and inter/outsourcing partners to achieve required standards
A minimum of approximately 8 years of experience in clinical biomarkers/ CDx, and/or translational researches in a global pharmaceutical company
Demonstrated “hands-on” experience in “fit for purpose” biomarker assay development under regulated environment for clinical implementation using varieties of technologies (e.g. Clinical Genomics, RNAseq, NGS, FACS, and ligand binding assay, etc.)
Expertise in clinical biomarker discovery and development, with advanced skills in biomarker assay design, development, troubleshooting, transfer, validation and sample analyze
Strong understanding of scientific and operational requirement (considerations) in executing biomarker and/or CDx strategies in clinical development is required. In depth understanding of clinical drug development strategies
Proven experience with reviewing of clinical trial related documents from his/her area of expertise for (e.g. LSD, LES, CTP, CTP amendments)
Proven abilities in managing outsourced clinical biomarker projects within quality, timeline, and budget expectations
Strong track record of publications in clinical/translational biomarker study as well as contribution/authorship of documents for regulatory submission
Must have experience in oncology
Broad knowledge of the clinical development process (Pharma R&D and Clinical)
Strong knowledge of national & international regulatory requirements and compliance. Experience facing inspections by regulatory agencies, a plus
Strong project management
Able to assess risk & develop contingency plans
Good presentation and excellent communication skills
Demonstrated ability to work effectively both independently and collaboratively in a dynamic, team-oriented matrix environment
Proven time management skills and ability to be flexible to meet job demands

Principal Scientist, Microbiology Resume Examples & Samples

A minimum of a Bachelor's degree in Biology, Biochemistry, Medical Technology, Microbiology, or related field with at least 10 years of R&D experience in a drug, device or biologics manufacturing environment OR a Master's degree with at least 7 years of R&D experience in a drug, device or biologics manufacturing environment OR a PhD with at least 4 years of R&D experience in a drug, device or biologics manufacturing environment is required
Knowledge of cGMPs is required
Knowledge of Industrial Microbiology, Formulation, Preservatives, and Compendia particularly USP chapters 61,62,1227,1111, and 51 are required
Experience with regulatory inspections, regulatory submissions and auditing is preferred
Excellent verbal, oral presentation, and written communication skills are required
Strong Microsoft Office proficiency, including Outlook, Word, Excel, and PowerPoint is required
This position is located in Fort Washington, PA and will require up to 10% domestic travelR&D

Principal Scientist Resume Examples & Samples

Responsibility for the development, qualification and validation of cell based neutralizing antibody assays and responsible for oversight of all cell based neutralizing assay performance both internally and at CRO partner laboratories in support of the BMS portfolio
Knowledge of the mechanism of action of therapeutics in BMS pipeline to aid in development of appropriate cell based functional assays
Leads a team of approximately three scientists in the development of bioanalytical functional (cell-based) assays
Understanding of immunogenicity risk assessment for biotherapeutics
Contributes to the preparation of technical reports, Health Authority filings and queries
Contributes to the preparation and presentation of scientific material at internal and external meetings
Ensures compliance with departmental SOPs, safety guidelines, and other applicable regulations
Ensures that notebooks and other documents are reviewed and compliant as per departmental SOPs and health authority regulations
Employ the most current scientific techniques and methodologies by keeping abreast of literature, presentations and health authority guidelines
Achieve objectives in a manner consistent with the BMS Biopharma Behaviors
Incumbent will be encouraged to publish in peer reviewed journals as part of project publication plans
Interaction with multiple teams in pre-clinical and clinical development as subject matter expert on immunogenicity and on neutralizing antibody assays
PhD in relevant scientific discipline (biology, immunology, biochemistry, chemistry, cell biology etc.) with 10+ years of relevant industry experience
Should have proven technical expertise and hands-on experience with development, execution, and troubleshooting of cell based functional cell based assays, mammalian cell culture, technologies such as ELISA (Direct and Indirect sandwich formats), Luminescence, Colorimetric, LC/MS/MS detection platforms
Extensive experience with development of cell based functional assays in GMP (potency assay) or GLP laboratory (NAb assay) required
Basic understanding of immunology, oncology, and other therapeutic areas in order to develop functional assays that reflect mechanism of action
Experience with developing automated sample handling and assay processes is desirable
Knowledge of GLPs, 21 CFR Part 58, Bioanalytical Guidance (FDA, EMA), Immunogenicity Guidance (FDA, EMA) is desirable
A working knowledge of protein biochemistry and characterization is beneficial
1603655

Principal Scientist Resume Examples & Samples

Responsible for development and characterization of late stage protein purification processes suitable for PPQ, licensure, and commercial manufacturing
Responsible for managing outsourced process development and characterization activities at CMO/ TPO
Identifies new technologies and works to implement new platforms with cross-functional early and late stage development teams
Managing biotechnological development projects
Relevant downstream purification experience and experience with monoclonal antibody process development
Demonstrated initiative, and innovative process-oriented thinking within a team environment
Experience with supporting regulatory filings for US and worldwide markets preferred

Principal Scientist Resume Examples & Samples

Provide senior technical leadership for drug substance development and characterization teams including
Eight (8) years relevant experience in leading and managing biotechnological development projects
Recognized scientific leader in upstream cell culture bioprocess development
Strong track record of excellence in cell culture process development, and development of commercial scale upstream processes
Experience with technology transfer across sites and geographies
Experience with supporting regulatory filings for US and worldwide markets
Experience in manufacturing sciences preferred

Principal Scientist Biologics & Vaccines Resume Examples & Samples

Highly developed communication, team building and interpersonal skills
Ability to function well in ambiguity
Track record of achievement in the Biopharmaceutical industry particularly in the areas of biologics or vaccines analytics
Exemplary scientific record, plus clear knowledge of compliance and regulatory landscape in large molecule analytics especially with respect to assay validation
Experience with the following techniques: Bioassay, ELISA, Glycan analysis, Chromatography, Electrophoresis, Peptide mapping, LC/MS
Lead design and execution of method transfers to national and global network of biologics and vaccines nodes. Participate locally as required (up to 30%)

Principal Scientist Protein Purification Resume Examples & Samples

Solid, proven hands on experience in column chromatography, protein purification method development and optimization
Deep and broad knowledge of protein analytical assays including chromatographic and biophysical characterization methods such as HPLC (SEC, IEX, RP), capillary electrophoresis, IEF, dynamic and static light scattering,
Previous experience managing direct reports with a proven track record of developing careers

Principal Scientist Process Development & Engineering Resume Examples & Samples

Cell culture media and feed optimization and development
Cell characterization and cell culture process development
Implementation of new proprietary media and feeds for GMP use
The candidate will also be involved in developing new technologies in a team environment
Experience in proprietary chemically-defined cell culture medium development. Experience in developing highly concentrated stable media formulations
Experience in GMP implementation of proprietary media and feed components
Experience with the operation of small scale bioreactors
Solid understanding of the impact of cell culture medium components on mammalian systems, and under different cell culture process conditions
Ability to apply statistical designs and analyses to develop new proprietary media and feeds to improve mammalian cell culture processes
Strong skills in critical thinking, laboratory experimentation and data analysis
Track record of scientific contributions
Strong communication and interpersonal skills to work in a team environment

Principal Scientist Resume Examples & Samples

Extensive experience in the concepts and methods of large molecule bioanalytics (monoclonal antibodies, therapeutic proteins, related modalities) including deep knowledge of current industry standards and developments across platforms (immunoassays, mass-spectrometry based)
Detailed and specific understanding of drug quantitation and anti-drug antibody assessment approaches and methods, and proven track record of successful implementation in the area of preclinical drug development
Ability to develop target-, program- and stage-specific bioanalytical strategies to optimally support programs and teams
Excellent communication and interpersonal skills are critical due to unique position as key liaison for customers and stakeholders into the bioanalytics groups and networks within the larger organization (across Merck sites)
Excellent organizational skills and keen interest in applying database solutions to optimize operational flow

Principal Scientist, Biologics Discovery Resume Examples & Samples

The central core modeling and quantitative expertise for the Department. The modeling efforts will be in support of projects related to
Minimum of 8 years of combined industry and/or postdoctoral experience in relevant field with strong focus on application of quantitative sciences in drug and biologics development
Strong experience in PK-PD modeling, simulations and application of biostatistics and PK-PD approaches
Strong communication, managerial experience, writing skills and ability to function in a highly team-oriented environment
Background and familiarity with the fundamentals of pharmacology, physiology and basic principles of drug actions, and the drug development process

Principal Scientist, Epidemiology Resume Examples & Samples

Has overall responsibility for worldwide pharmacoepidemiologic planning and study recommendations for assigned Merck products in the Infectious Disease Therapy Area. The Pharmacoepidemiology Department supports all drugs, vaccines, and biologics in all therapeutic areas. Although staff are expected to develop primary subject matter expertise in one or more therapeutic areas, staff may receive assignments in any therapeutic area depending on need
Has lead responsibility for interaction with risk management subteams, value evidence subteams, clinical/regulatory subteams, and other areas of Merck Research Laboratories on epidemiologic matters related to product safety and risk management, post-marketing safety studies, regulatory activities, clinical study design and biomarkers/molecular epidemiology/genetic epidemiology
Has responsibility for the design, conduct, and analysis of epidemiologic research studies on assigned Merck products worldwide
Provides scientific oversight and mentorship to more junior Epidemiology staff
May present epidemiologic research plans and results to internal review and governance committees; to external agencies such as FDA (including advisory committees), EMA, CDC, AHRQ, and WHO; and at scientific conferences
Maintains close working relationships with colleagues in Clinical Safety and Risk Management, Clinical Research, Regulatory, Outcomes Research, Health Economics and Commercial. Assists them in areas where knowledge of epidemiology is relevant
May hold academic appointments, teach graduate courses, and supervise Ph.D. dissertations and post-doctoral fellows
Experience in the successful direction of large epidemiologic projects
Knowledge and experience in the application of epidemiologic approaches to problems in the Pharmaceutical or Biotechnology industry
Excellent communication skills (oral and written)

Principal Scientist Resume Examples & Samples

QP2 Principal Scientists apply PK/PD and M&S approaches to design and evaluate clinical and preclinical study data, characterize the kinetics of drug absorption and disposition, assess the dynamics of drug effect, and inform dose selection and go/no-go decisions
Principal Scientists also maintain a comprehensive understanding of global regulatory expectations for small molecules and biologics, including authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
The QP2 scientist is a quantitative drug developer, with a strong, integrated understanding of the strategic elements of drug development (early through late), and leads the combined efforts of QP2 & the wider Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM)
A minimum of 7 years of experience in a similar role in pharmaceutical drug development, with an exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches
Strong skills in experimental design, mathematical problem solving, critical data analysis/interpretation, statistics, and hands-on computer modeling skills are highly desirable (including proficiency with one or more of the following software packages, such as, but not limited to: NONMEM, Matlab, sPlus, R, WinNonlin)
Solid proficiencies in written and verbal communication, interpersonal skills, problem scoping and planning, and the ability to participate in and lead interdisciplinary teams, are critical

Principal Scientist Resume Examples & Samples

Manage individuals who are responsible for product development stages including Clinical Trial Applications (CTAs) in Phase I-III, Product Registration and Launch (PR&L) filings, and post filing activities
Manage individuals that develop and implement regulatory strategy to support lifecycle management of In-line products
Create and drive implementation of the ROW regulatory strategy for their own assigned products
Review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues
Provide regulatory review of product labeling. Responsible for the strategy and release of supplementary safety and efficacy supplements to update the label
Collaborate with Regional Liaisons and Country Regulatory Leads and with other functional areas within Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories, and across divisions (Global Human Health and Merck Manufacturing Division) to ensure that a common set of priorities and objectives are developed for ROW filings and for lifecycle management activities
Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products
Conduct all appropriate HR activities including managing performance, development planning; staffing and related people-management responsibilities for liaisons within areas of responsibility
Mentor team members and provide guidance on various aspects of Regulatory Affairs and their projects
Lead and drive organizational initiatives on behalf of the RAI-HQ Leadership Team and represent RAI-HQ on cross-functional/cross-divisional teams
A minimum of 8 years of relevant experience in the pharmaceutical industry
The ability to work effectively both independently and in a team environment, good organizational skills, proven ability to balance diverse activities for multiple projects

Principal Scientist Resume Examples & Samples

Lead and resolve complex quality and compliance issues
Collaborate and be the point of contact regarding pre-qualification of World Health Organization filings for certain products
Ability to travel internationally when needed

Research & Development Principal Scientist Resume Examples & Samples

Develops platform processes and controls that can support manufacture of different types of sterile products e.g. Potent products, Aseptic liquids/lyophiles, Suspensions and sustained release products
Minimum of a third level Degree in Engineering or Science related discipline
Minimum of 8 years’ relevant experience with preferred experience in development, scale up and manufacture of sterile products
Knowledge/ experience of development and scale up of sterile/aseptic manufacturing processes for a variety of parenteral dosage forms
Experience with process development and successful scale up from laboratory/pilot to commercial scale
Knowledge of sterile processing unit operations and controls, scientific and engineering principles of scale up, QbD, GMP requirements for sterile product manufacture

Principal Scientist Resume Examples & Samples

Communicate with clarity the results of modeling in presentations to key stakeholders
Contribute to translational plans and assessments and study conduct
PhD with a track record of productivity in the areas of systems pharmacology, computational biology or related field, as manifested in publications and presentations
A minimum of 3 years of experience in biomedical research post-education. Extensive knowledge of biological pathways relevant to disease
Superb skill in communicating both highly technical material as well as the distilled take-home messages
Modeling and computational experience, Excellent scientific computing and programming skills in a variety of computational tools such as MATLAB, Monolix, NONMEM, Mathematica, R and excellent working knowledge of Linux and Windows environments
Extensive knowledge of biological pathways relevant to disease
Superb skill in communicating both highly technical material as well as the distilled take-home messages. Modeling and computational experience
Experience in disease modeling. Expert knowledge in at least one area (e.g. immunology, cardiovascular) highly desirable
Experience in drug discovery/development a plus, especially quantitative aspects such as PK-PD, basic experience in Pharmacometrics or Clinical Pharmacology
Level of the Scientist dependent upon years experience

Principal Scientist Resume Examples & Samples

Responsible for the defining and managing the necessary programs and academic collaborations to understand the fundamental science that underpins container closure Platforms developed by the Primary Container Center of Excellence
Responsible for monitoring of emerging and exploratory technology offerings in areas associated with Primary Container Platform portfolio
Responsible for conducting technology assessments, leveraging the central CoE capabilities (Material Science, Analytical Chemistry and Functional testing labs) and other assets in the network (MED Early Stage portfolio resources, external vendors, …), to identify potential weaknesses, as well as novel solutions, materials and suppliers
Responsible for establishing and maintaining a network of Primary Container expert, within the global Sanofi group (including Genzyme, Pasteur and Merial) for best practice dissemination, providing support in methodology and problem solving related to primary container development and industrialization
Support the Head of CoE in the definition of the strategic technology roadmap for PC assets, in liaison with relevant stakeholders (Sanofi GBU, MED Platform Directors, DP Development centers, IA Manufacturing Units SFI, SFP, SFD …)
Act as a global SME in Primary Container field, supporting commercial and marketing teams
Masters of Science degree (or equivalent/higher degree) in Engineering, Chemistry, Physics or Material Science
7+ years of experience in primary packaging of biologics
20-30% travel both domestic and international
Previous experience in development programs requiring exposure to multiple functions across R&D and Industrial Operations
Experience in collaborative programs (academic, private research labs) aimed at development of innovative products with high technology content
Demonstrated technical background in Drug Delivery system of injectables, including expertise in the design, development and manufacturing processes for container closure components
Systems engineering understanding and application experience in a regulated environment. Additional required technical competencies or understanding include medical device development and design, risk assessment and FMEA
Ability to operate in an international, cross-company and cross-functional environment. - Professionalism and demonstrates solidarity with organization and team members. - Communication and inter-personal skills necessary to build trust, confidence and collaboration toward shared objectives. - Creativity and common sense. - Issue and conflict analysis and resolution across all levels of an organization, as well as external partners
Project management competencies in areas such as resource planning and management, project planning and management, and risk planning and management are a significant plus
Language - Good communication skills (written and oral) - Written and oral fluency in English is required. - Written and oral proficiency in German and/or French is a significant plus. #LI-SA

Principal Scientist, Gene Therapy Resume Examples & Samples

Design and execution of experiments supporting improvement of upstream processes and vector production technologies. Evaluate new technologies and develop strategies for their implementation into Gene Therapy vector manufacturing
Incumbent will document and communicate scientific data to line management and functional sub-teams through technical and monthly reports, and internal/external presentations
May provide technical oversight and have managerial obligations for junior staff
Apply scientific principles and experiential knowledge to solve complex problems in creative and practical ways

Principal Scientist Discovery Toxicology Resume Examples & Samples

As part of the Global Discovery Toxicology Team work in interdisciplinary teams within and across Global Safety Assessment to provide safety support to early discovery drug hunting teams and engage in core activities within the Discovery Toxicology group
Work as part of a team of safety assessment scientists and more broadly DMPK, pathology, pharmacology, and medicinal chemistry experts to implement discovery toxicology strategy to enable the selection and progression of optimized drug candidates
Provide target safety review and proactive risk mitigation plan for early drug discovery project teams based on literature, bioinformatic, and other predictive tools
Lead the development of early hypothesis-driven investigation into mechanisms of toxicity for the proactive management of potential safety liabilities and communication of impact to teams
Develop novel toxicity mechanism-based assays and integrated models to support early target safety and chemistry evaluation
Creative scientist with experience in the development and application of novel cell based screens for early safety assessment to explore on and off target toxicity using advanced cell/tissue culture approaches, systems biology, integrative bioinformatics, and in silico prediction tools. Facility with bioinformatics and the ability to integrate and interpret data across multiple disciplines including toxicology, pharmacology, DMPK, and pathology
Deep understanding of drug development process and the field of predictive/discovery toxicology and its application through use of novel approaches and technologies
Prefer PhD with postdoctoral experience with additional industry experience; 8+ years. Will consider Masters with 18+ years experience to provide intellectual and investigational leadership for discovery/predictive toxicology efforts. PhD and experience in molecular toxicology, pharmacology, cell biology, and similar disciplines. Work with immune, liver, renal, CNS, or cardiovascular toxicity models a plus. Strong data analysis skills
Problem solver with strong organizational and interpersonal skills with an ability to develop strong working relationships across interdisciplinary lines
Excellent communication skills, both oral and written, are required

Principal Scientist Resume Examples & Samples

Lab based scientist with science leadership skills taking a lead role in the planning, design and delivery of recombinant proteins
A key aspect of this position will be communication both within the protein group and across multiple disciplines (project teams, enzymologists, crystallographers and CADD groups) ensuring that information on work progress is relayed in a clear manner, highlighting any technical issues and providing potential solutions
A major component of the role involves understanding the structure of target proteins and how this relates to their biological function and applying that knowledge to help progress projects
Familiar with E.coli, insect and mammalian cell expression systems
Fully independent in purification techniques (affinity chromatography, ion exchange, SEC and HIC)
Extensive working knowledge of AKTA purification platforms and associated software
Excellent biochemistry knowledge with hands on experience of protein labelling and characterisation
Comprehensive knowledge and experience with software used in manipulating protein and DNA sequences (VNTI) and molecular visualisation of proteins (PyMOL or similar)
Experienced in the full process of x-ray crystallography; setting up crystallisation experiments, x-ray data collection, data processing, structure solution and refinement
In addition, all applicants must possess excellent written and verbal communication skills, a good publication record and evidence of a being well connected within the scientific community

Principal Scientist, Bone Research Resume Examples & Samples

Support the science of clinical candidates in development through late stage clinical trials, regulatory filing and market launch
Build in vitro models and assays to support drug discovery in the musculoskeletal disease area
Identify and validate drug targets by establishing or utilizing complex cell culture models to test therapeutic hypotheses and drug candidate selection
Work as a team with other colleagues and execute complex, multistep studies. Responsible for delivering reproducible and well-controlled datasets according to project timelines for project advancement decisions
Develop good understanding of musculoskeletal biology and its relevance to musculoskeletal diseases in the context of ongoing projects within the Bone Therapeutic Area
PhD or equivalents in a biology-related field with extensive experience working in an academic research or drug discovery environment
Hand-on experience in bone cell biology research using bone cell in vitro model systems
Preferred experience in osteocyte biology, complex cell co-culture, genetic manipulation approaches, stem cell differentiation, cell signalling endpoints, imaging techniques
Excellent scientific publication and presentation records
Design the experiments and perform assays using in vitro models to generate high quality data to provide mechanistic insights
Establish novel in vitro models using complex cell co-culture approaches
Experienced in the use of cell biology analytical techniques including flow cytometry, and molecular/proteomic technologies
Proficiency in written study protocols, study reports, regulatory documents, and peer-review publications
Excellent presentation skills with the ability to convey ideas and information clearly in internal and external presentations
Excellent attention to detail with the ability to maintain meticulous documentation of experiments and data

Principal Scientist, Discovery Analytics Resume Examples & Samples

The individual should have demonstrable experience and passion for mathematics, statistics, signal processing, image analysis, machine learning, data mining, and data visualization
Deep knowledge of scripting and analytics software, including R, Python, Pipeline Pilot or KNIME, Tableau,or Spotfire
Fluent in big data management tools, Hadoop, NoSQL datastores as well more traditional relational databases
Demonstrable expertise in Machine Learning toolkits and major programming frameworks
Good understanding of Deep Learning and Natural Language Processing is desirable
Knowledge of Life Sciences software such as Vortex, Definiens, CellProfiler, FlowJo, ForeCyt etc.would be an advantage
Good understanding of Biology, Chemistry, and Drug Discovery is required
Strong communication skills to ensure alignment between scientists, management and Informatics experts

Principal Scientist Resume Examples & Samples

Supervise standard and advanced laboratory activities including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Teva, FDA and other governing bodies
Design, develop and supervise the execution of approved method transfer protocols, development and validation of all analytical methods
Write protocols, reports, methods and standard operation procedures
Write regulatory submission modules and any other documents to support submission and product approval
Develop statistical design of experiments with minimal supervision
Independently design and develop manufacturing processes and conduct manufacturing activities for MDI/DPI/Nasal drug products
Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design
Provide expert support for analytical and/or manufacturing related technical issues
Develop and implement appropriate training programs for analytical or manufacturing activities across all respiratory development sites
Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicate effectively with team members and internal or external customers
Work and communicate effectively with other functional groups and across global respiratory R&D sites
Independently lead major project tasks
Establish and maintain effective relationships with team members
Conduct lab work in accordance with SOPs; follow Teva safety rules and procedures
Comply with all Teva Corporate guidelines and policies
PhD in analytical chemistry or related discipline with 5-8 years analytical research experience, MS in Chemistry with 10-12 years analytical research experience in pharmaceutical or related field
Broad knowledge of analytical techniques including HPLC, GC, UV, FTIR and/or broad knowledge of development and manufacturing activities for MDI/DPI/Nasal products
Knowledge and detailed understanding of global regulatory requirements as applied to Respiratory or Nasal delivery. Good understanding of USP methodologies and ICH Deep knowledge of the FDA cGMP requirements as they apply to the Pharmaceutical industry
Strong communication skills-both verbal and written

Principal Scientist Resume Examples & Samples

Be a champion of innovation to ensure Zoetis leadership in biopharmaceutical and vaccine characterization. Apply broad skills and knowledge in the discipline gained through experience in characterization of new biopharmaceuticals and development of antigen assays in vaccines
Lead through example by working hands-on at the bench to develop and execute analytical methods
Coordinate and oversee transfer of analytical methods to manufacturing QC laboratories
Assist regulatory colleagues in preparing, editing, and refining regulatory submissions for biopharmaceuticals and vaccines
Author study reports that describe method development and qualification
Represent the biopharmaceutical analytical function on global project teams for development of new veterinary biopharmaceuticals. Contribute at the functional level to the direction of project teams and facilitate decision making in the realm of analytical issues that affect project direction and progress
Strive for continuous improvement by identifying new technologies that shorten analysis time or provide new information
Develop constructive working relationships in both internal and external networks for the purpose of strengthening the biopharma analytical function and to align team goals with organizational objectives
Coach and mentor Zoetis colleagues in the analytical team and provide direction to contingent workers and contractors providing support to the function
PhD or MS in Analytical Chemistry, Biochemistry, or a related discipline with at least 5 years hands-on industry experience in protein characterization and methods development
First-hand knowledge of the regulatory requirements (FDA, EMA) that apply to the development of physical/chemical methods for GMP control and release of biopharmaceuticals
Demonstrated track record as a leader of both projects and people
Strong theoretical knowledge in the scientific disciplines that support physical/chemical protein characterization and method development, such as protein chemistry, analytical chemistry, physical chemistry, and organic chemistry
Comprehensive understanding of the tools used in protein characterization: capillary and slab electrophoresis, RP and IEX HPLC, mass spectrometry, protein sequence analysis, amino acid analysis, peptide mapping, circular dichroism, differential scanning calorimetry, ligand binding assays
Practical, hands-on experience with instrumentation and software used in three or more of the techniques listed above
Demonstrated track record in developing efficient and robust methods for control of GMP manufacture
First-hand knowledge of the regulatory expectations for critical aspects of biopharmaceutical filings, including product release, product characterization, and stability

Senior Scientist / Principal Scientist Resume Examples & Samples

PhD in veterinary parasitology
Excellent oral and written communication and interpersonal skills. Fluency in English is mandatory
Able to work both as a member of a team and independently, in a self-directed manner
Veterinary degree (DVM)
Previous experience in the Animal Health pharmaceutical/vaccine industry or of parasitology. research in an academic or commercial environment
Able to work efficiently under pressure to meet multiple project timelines
Ability to understand, influence and motivate colleagues in a matrix organization

Principal Scientist Resume Examples & Samples

BS, MS or Ph.D. in Food Science, Food Engineering, or Chemical Engineering with 7+ years of food industry R&D experience
Minimum 5 years of frozen appetizer product development experience with knowledge of and technical achievements in multiple production technologies preferred such as battering, breading, forming, rolling, filling, mixing, blending, cutting, frying, freezing, coating
Strong knowledge in ingredient functionality & formulation chemistry, and demonstrated of product innovation from idea to commercialization
Possess strong work ethic and ability to be a self-starter
Outstanding teamwork and communication skills with proven ability to influence internal & external partners in challenging business situations
Strong organization, documentation, and formula management skills
Ability to function effectively in a dynamic and fast-paced environment as well as manage multiple projects simultaneously
Must be willing and able to travel 10-25% of the time

Principal Scientist Resume Examples & Samples

Independently designing and executing MS and MS/MS product characterization studies
Conducting detailed peptide mapping and PTM analysis using advanced software
Authoring technical reports, procedures and guidance documents
Contributing to IND/BLA regulatory filings and responses to Health Authority questions
Presenting at scientific conferences and providing educational seminars internally or externally
Working with managers to standardize/improve phase-appropriate characterization activities to improve efficiency
Managing HCP characterization by MS as appropriate
Evaluation of new and emerging analytical MS technologies

Principal Scientist Late Phase Downstream Process Development Resume Examples & Samples

Successfully demonstrated several years (mini-mum of 3 years) of directly related experience as principal scientist or equivalent
Recognized expertise in a specific area
Proven track record in utilization of special tools/equipment, lab automation tools and spe-cialized facilities e.g., containment/sterile labs
Thorough knowledge of state-of-art instrumentation/equipment for broad field of applications
Thorough understanding of development processes in a specific function
Strong knowledge of relevant SOP, GLP, DQP, GMP and Novartis regulations and policies
Strong presentation skills and scientific/technical writing skills
Advanced coaching skills

Principal Scientist Resume Examples & Samples

Lead a team of 4-5 scientists in developing a diagnostic immunoassay from biological test design through participating in regulatory submission (510k); the product is a medical device that tests for the Zika virus
Materials process development and developing reagents
Lead a cross functional team, representing assay development’s interest to other departments
Preform assay plate design for immunological assays or assays with a biological target; lateral flow immunoassays

Principal Scientist, Analytical Technology Resume Examples & Samples

Serve on cross-functional project teams to represent Analytical supporting Oncology products
Represent Analytical on cross-functional project teams
Active member of tech transfer teams and take lead technical role for method transfers, qualifications and validations
Provide technical assessments for proposed changes to specifications and methods for raw materials, API, in-process intermediates, and drug products
As needed, partner with Shire’s R&D function (Product Development, Regulatory Affairs) regarding testing and methodology
30% Departmental Responsibilities (30%)
Manage analytical activities and projects to meet the strategic and project goals
Ensure the timeline for technical tasks are met and facilitate corrective action to get the timeline back on track when adverse events cause a task to slip
Provide input for planning, budgeting, and staffing requirements to support Small Molecule Operating Unit projects and initiatives
20% Compliance Documentation (20%)
Serve as the Analytical lead author and subject matter expert for CMC sections of Post-Approval Supplements
Serve as global change control reviewer for analytical and ensure appropriate compliance on changes to methods and specifications
Author / Review / Approve validation, qualification, or transfer protocols
Ensure training is current and compliant
Proactively communicate across Analytical and Sm OpU
Normally requires an advanced degree in a scientific/technical discipline with 8-12 years related experience or a BS with 12-15 years
Has strong understanding of quality and regulatory requirements
Experience with European (or other ex-US) regulatory requirements is a plus

Principal Scientist, Body Platform R&D Resume Examples & Samples

Establish and conduct independent and innovative research programs within a multifunctional environment
Identify and develop new technical insights, technology targets, and technologies to deliver consumer and clinical benefits for body, including compromised skin, aligned with current strategies
Develop a pipeline of projects for Body Platform
Document research results for internal reporting and invention disclosures to enable patent application. Develop and execute appropriate strategies for protecting the resulting intellectual property
Design and execute clinical proof-of-principle studies, for fundamental clinical understanding of how products function, to understand consumer perception and acceptance of technologies and products, and to demonstrate benefits of technologies for body, including compromised skin, applications
Design and execute in vitro studies to screen and evaluate technologies
Partner closely across R&D and business functions (ie. Marketing, Global Strategic Insights, Consumer Science), to develop and align on strategic business and pipeline plans to guide platform development
Conduct competitive technical intelligence related to scientific research, technology, and applications
A minimum of a Bachelor’s degree in biological, pharmaceutical, chemical science, engineering or related science with a minimum of 6 years of experience OR a Master’s degree, with 4 years, OR a Ph.D. with 2 years of experience is required
Experience in the design and execution of in vivo studies of cosmetic and/or OTC products on human subjects is required
Experience in statistical analysis of experimental and/or clinical data is required
Knowledge of cosmetic formulation is highly preferred
Track record of conceiving new technical leads/insights and championing them to execution is required
Prior experience working in a GMP/GCP environment with completion of GMP/GCP documentation is preferred
Experience with measurement science techniques for in vivo characterization of skin, and design and execution of consumer-use studies of consumer products, is preferred
Experience conducting patent and/or literature searches is required
The ability to partner with cross functional teams within a research and development environment is required. Leading and managing technical projects is required
The ability to create and deliver technical presentations to both technical and nontechnical business audiences is required. Good written and verbal communication skills are required
This position is based in Skillman, NJ and may require up to 10% travel

Principal Scientist Technical Support Resume Examples & Samples

Design Control & Risk Management - Effectively balances compliance risk and business risk and utilizes expertise in Risk Management in evaluating design changes and product field issues
Complaint and Internal Investigations - Leads investigations and global activities and may facilitate the resolution of multiple investigations. Subject Matter Expert (SME) in statistical; experimental design; investigation techniques and tools (e.g. Six sigma DMAIC); and in all product processes for audit support
Technical Support - As SME; participates in multiple teams to investigate system issues that span multiple functions and ADD Sites. Lead in the resolution of complex product and process problems. Helps to ensure CFTs maintain focus on root cause for Global Investigations and encourages excellent cross-Site communications. Obtains data and performs intensive analysis in support of investigations and resolutions. Keeps documentation up to date and reports to the Investigation CFT
Sharing Knowledge - Represents ADD at external conferences and advances the level of technical expertise within ADD. Makes connections and draws synergies across ADD Sites by facilitating good communication practices and participating as a SME for investigations; data mining and analysis. Liaison with centers of excellence; Commercial organization; customers and external opinion leaders
Strategic and Results Orientation - Demonstrates fiscal responsibility through actionable recommendations and accomplishments. Maintains product availability and improvements in product sustainability. Translates business needs of management and respective top-level goals into specific project level goals for individual team members and aligns activities with respective strategic business priorities. Resolve identified resource limitations and; if appropriate; drafts funding requests
6 or more years related work experience. Advanced degree preferred. (Advanced degree(s) may offset required years of experience)

Principal Scientist Resume Examples & Samples

Coordinates all aspects of managing/method development, validation, and specialty service within division. Prepares, reviews and approves bids and proposals
Supervises senior technical staff in lab operations (scheduling, resource management, technical and compliance), and directs lab activities of direct reports
Leads client communications regarding scientific issues, study design and project technical requirements
Plans, directs and implements improvements in systems, processes and procedures to increase lab efficiency, productivity, quality and technical expertise
Independently leads and oversees programs for analytical method development for pharmaceutical and biotech products
Requires: MS, Chemistry (any area), with 6 years’ regulatory lab experience as chemist; PhD with 4 years’ experience; or BS with 8 years’ experience. Experience must include 2 years of management responsibility
Must have excellent technical capabilities with analytical expertise in method development and/or specialty technology
Proven ability to implement change based on analysis of root causes, need, and experience and drive cross-function SOP changes
Demonstrated understanding of the bid process
Knowledge of budgeting, forecasting and fiscal management
Proven ability to identify and implement common efficiencies across multiple programs/projects
Fulltime. Resume to: Christine Stoikes, PPD Development, LP, 8551 Research Way, Ste 90, Middleton, WI 53562-4664 (job location); or fax: 608-827-8807. Reference #SN082616

Principal, Scientist, Senior Resume Examples & Samples

Carries out project team management and other responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws
Method Development and validation in ICP/MS for elemental analysis
May supervise, coordinate, prioritize and lead the daily activities of a group of intra- and inter-departmental team members including Analytical Scientists and schedule their workloads
Develops project goals and timelines in compliance with Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines
Maintains appropriate documentation of records, report sheets and laboratory notebooks; prepares and executes complex protocols and final reports to ensure compliance
Performs test formulations for new projects; designs and plans experiments and protocols; critically analyzes data and research information; performs physical, chemical and functional evaluation of materials, components, intermediates and finished products
Prepares method development, method validation, analytical strategy reports and other relevant scientific information packages for internal and external use by the Company
Assists operational departments and Company management with pre- and post- approval inspections, and Regulatory Affairs filings
Ensures compliance with all Company policies and procedures, including safety rules and regulations
Performs and may oversee the development and validation of methods for testing raw materials, drug substances and drug dosage forms. Also may be responsible to oversee the performance of accelerated and room temperature stability studies for new products (experimental and site qualification lots) as well as the evaluation of stability data and the submission of stability data required for ANDA submission
Oversees the analysis of competitor products, drug substances, excipients, and experimental products to provide information for Product Development, the dissolution testing of competitor products, the physical characterization of drug substances, excipients, and dosage forms
Provides scientific and technical leadership to junior staff members in support of Product Development meeting its project deadlines and performance standards. Collaborates closely with Pharmaceutics to set priorities and reach Product Development objectives
Prepares and presents written and oral reports on research findings, project status, literature reviews, and technical issues that affect the business
Provides formal and informal training to research staff on technical subjects, administrative procedures, and regulatory requirements
Selects, justifies, and implements appropriate instrumentation, computer programs, and procedures to achieve product development support objectives
Pertinent SOP laws related to pharmaceutical laboratory testing, analyses and documentation
FDA, DEA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines
Project management, leadership, team building and training practices and methods
Working with a high degree of independence and conceiving of and achieving technical goals with little or no technical supervision. Training of junior staff
Directing the activities of technical personnel, making decisions, and satisfying the needs of a research program
Technical Writing
Responding to complex inquiries from management, employees and regulatory agencies
Communicating clearly and concisely, both orally and in writing
Leading, coordinating and reviewing the work of assigned Project team members

Principal Scientist Resume Examples & Samples

Designs, implements, and conducts experiments aimed at evaluating and differentiating assets and enhancing the value of assets from early discovery to early clinical trials
Plans, designs, and coordinates studies at contract laboratories
Initiates and manages interactions and collaborations with key academic collaborators in the field of gastrointestinal diseases
Collaborates with program leaders to ensure timely progress of drug discovery programs
Generates ideas/research strategies, implements them and produces results that are of importance to the company
Prepares Research Reports for IND/NDA submission
Assists in preparation of reports and other documents for submission to domestic and international regulatory such as the DEA
Plans, designs and initiates studies, and analyzes the data in preparation for final reports
Ensures compliance with good laboratory practices and other regulatory guidelines
Leads efforts to differentiate Takeda compounds from competitors by applying cutting-edge biology
Interfaces with internal research groups and clinical groups and assures laboratory productivity and technical research flexibility
Designs complex experimental strategies to discover probable drug targets or candidates that address project goals; provides technical advice to others; has appreciable latitude for unsupervised action or decision
Executes discovery process; frequently determines research project deadlines within department
Identifies complex obstacles to progress; recommends and implements solutions using a diverse set of resources; solves problems in creative and effective ways; challenges current processes and recommends novel approaches
Manages Research Associates and lower level Scientists
Manages more than one project of broad scope and complexity
Represents own research to senior leadership, or for scientific collaborations, or at national scientific conferences recognized in the therapeutic disciplines
Ph.D. in cell biology, biochemistry or related field with thesis, publication(s) and minimum 8 years of relevant experience, OR
MS/MA in life science with 14+ years of relevant experience and distinguished publication record, OR
BS/BA in life science with 17+ years of relevant experience and distinguished publication record
Expertise in the application of cutting-edge biology to discovery projects
Highly knowledgeable of GI pathophysiology, and leverages this knowledge to study target biology and evaluate molecular leads using relevant in vivo and ex vivo experimental models
Working knowledge of the use of structural biology as a tool for drug discovery
Demonstrates fundamental understanding of physiology and drug discovery within gastrointestinal diseases
Demonstrates inter-disciplinary knowledge of drug discovery and is able to use this knowledge to influence project strategy
Fluent in best practices and applications for the development and use of animal disease models and ex vivo studies to understand target biology and identify molecular drug leads
Track record of leadership in drug discovery as reflected by advancement of drug targets to clinical candidates
Has demonstrated independent thought/creativity in science
Demonstrates effective decision-making to guide and prioritize activities to support drug discovery programs
Excellent communication and multitasking skills and ability to work in a team setting
Possesses high degree of scientific discretion/intuition

Principal Scientist Resume Examples & Samples

Provides mentorship to Immunology staffs by providing scientific guidance and positive insight
Provides leadership of GI programs and mentoring of PTLs
Contributes to translational research activities, including biomarker discovery and validation, in partnership with the Translational Research & Early Clinical (TREC) team and expert external groups
Advances and ensures the success of innovative programs and external partnerships for immunology, in close collaboration with the GI DDU
Establishes rapport & collaborates with scientific leaders, KOLs, academic partners, CROs and biotech companies and is seen as an international subject matter expert in Immunology research and therapeutics
Manages teams in a matrix environment
Leverages external resources (vendors/CROs) and in building and supporting partnerships with academic institutions and/or companies
Supports biomarker discovery and validation for clinical translation of GI-Immunology programs
Works independently to generate and interpret data, troubleshoots, and suggests next steps
Keeps up with the up-to-date scientific advancement (e.g. competitive landscape, new technologies, emerging opportunities)
Spends up to 80% of time in the lab, developing new assays and mentoring staff
May allocate ~20% of the time to helping to identify, advance, and ensure the success of innovative external partnerships for GI-Immunology, in close collaboration with CEI and the GI DDU
May manage a nimble team of Immunology researchers
Ph.D. in Immunology or Biology with minimum 8 years of experience, OR MS/MA in Immunology or Biology with 18+ years of relevant experience OR BS/BA with 20+ years of relevant experience
Successful postdoctoral training in world-renowned laboratory, and have strong publications in high-impact peer-reviewed journals
Minimum 5 years of industry experience including leadership of projects in GI area
Well-versed in field of GI-Immunology, with good knowledge of competitive environment
Experience authoring study reports supporting IND filings

Principal Scientist Resume Examples & Samples

Partner with Immunology and Immunomodulation teams to understand and track biological and clinical questions, identify relevant genomics, genetics, epi-genetics, and proteomics datasets, and employ bioinformatics tools to provide comprehensive answers in a timely manner
Analyze omic scale data, including RNA-seq, DNA-seq, and ChIP-Seq, to integrate and mine external data sets to gain insights into disease pathophysiology
Summarize the results comprehensively to biologists and clinicians, communicate/interpret the findings to project teams, and document if and how the bioinformatics results impacted team decisions, project advancements, or governance reviews
Contribute to the global Computational Biology working groups, focused on developing best practices, and lead at least one area of global computational biology platform development
Identify, evaluate, and apply new methodologies and emerging technologies for improving bioinformatics capabilities
Independently performs scientific experiments, but also utilizes broad thinking with regard to achieving goals that can require developing new methodologies, protocols and/or test procedures
Seen as an established leader in specific discipline. Demonstrates understanding of research or development team goals and works effectively toward achieving them; Participate as representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals
Prepares clear technical reports, publications and oral presentations. Independently communicate results in the form of reports and or presentations; Presents responsibly and defends own work at scientific meetings; May deliver updates to senior level management in context of overall project goals
Demonstrates expertise in a specific scientific area or technology; Evaluate and propose new technologies and concepts, including recommending specific capital purchases of instrumentation, hardware and software; Demonstrates independent thinking, e.g., by proposing and implementing new experimental designs and concepts that contribute to research goals and reflect expert knowledge; Identifies potential patentable inventions
Assumes responsibility for direct reports as needed including recruiting, managing, mentoring and developing scientific staff; May direct and oversee experimental design and results of technicians and junior level scientists

Principal Scientist, Renal Biology Resume Examples & Samples

Utilize multiple preclinical models to evaluate novel therapies to treat chronic kidney disease, diabetic kidney disease, and renal fibrosis
Perform studies using ex vivo models related to kidney function
Perform in vivo studies with rodent models of chronic and diabetic kidney disease
Contribute to strategic planning of drug discovery programs in kidney disease
Established expertise working with in vivo models of diabetic kidney disease is required
Understanding of competitive landscape and current therapies for treating chronic and diabetic kidney disease is preferred
Understanding of the overall process of drug discovery and development is required
Ability to interpret results, accurately prepare presentations, and clearly communicate findings is required
Previous leadership experience is preferredR&D

Principal Scientist Resume Examples & Samples

Is responsible for ensuring strong alignment and interfaces with DMPK groups across US affiliates and Japan Discovery and Development
Collaborates with safety assessment group on study design, provides toxicokinetic data analysis and interpretation, and ensures strong alignment with Takeda development partners (Millennium, Japan, TPUS)
May serve as co-leader on TCAL cross-functional drug discovery programs as required
Manages other PhDs and/or Research Associates; typically a combination of direct and indirect reports; provides mentoring career development to scientific staff
Scientific strategic thinking; decisions will result in critical effect on the Company's long-term success
PhD in Pharmaceutical Sciences/Chemistry/Biochemistry or related coursework and 4-8+ years of relevant experience, or MS/MA with 14-18+ or BS/BA with 16-20+ years experience. Supervisory experience is highly preferred
Experience in serving on project teams in early discovery is critical. Managing the ADME and PK screening paradigm in early lead optimization, as well as early phase 1 design and human PK predictions are minimum requirements
Clear track record of accomplishment (e.g. publications, patents, presentations) including evidence of leadership in managing DMPK core activities one or more internally discovered compounds into preclinical and/or clinical development
Recognized in the field of DMPK by both the pharmaceutical industry and the academic community
Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues in other scientific disciplines
In-depth knowledge of the overall drug discovery process and demonstrated ability to successfully direct efforts on multiple projects simultaneously
Experience in compiling and writing IND modules is desired

Principal Scientist Resume Examples & Samples

Work with biologists to design studies that will optimize NGS technologies and bioinformatics analyses
Develop and/or modify bioinformatics methods to analyze NGS data, including cutting edge NGS technologies. Demonstrate validity of methods through prototypes
Validate and benchmark algorithms
Devise and run computational tests to validate pipeline performance
Collaborate across functional areas to develop custom solutions and customer-facing reports

100

Principal Scientist, Sequencing Resume Examples & Samples

The successful candidate should have strong background in molecular biology and microbiology related fields, with hands-on experience in next-generation sequencing assays. IVD assay development experience is highly desirable including working under design control regulations and GMP laboratory conditions
In-depth knowledge of NGS based workflows including nucleic acid extraction, target enrichment, library preparation, and data analysis is preferred
Basic microbiology and infectious disease knowledge and research experience are preferred
The individual will conceive, plan and conduct experiments independently, applying advanced scientific knowledge to complete projects, and may supervise junior scientists
Demonstration of strong writing skills is desired
Recommends innovative approaches, and/or expansion or curtailment of investigations based on experimental data or new scientific information arising from area of responsibility. Participates in project planning, process updates, and experimental design. Assumes responsibility for timely completion of projects, ensuring activities that are consistent with project critical path and responding appropriately to changing priorities
Ensures technical activities under delegated supervision are conducted within internal and external guidelines and regulations. Interacts with other departments to further project goals
Accurately and consistently records experimental methods, materials and results in electronic laboratory notebooks. Analyzes data, evaluates results, forms conclusions, and determines future experiments
Presents findings or comprehensive project status reviews at internal seminars/meetings. Applies advanced technical writing skills to produce reports and documents. Prepares summaries, internal reports, presentations, manuscripts, etc
Serves as an expert resource in a cross-functional team setting (e.g., Manufacturing/Operations, Quality, Marketing, Regulatory Affairs, Clinical Studies, and International Technical Services), provides timely response and follow-ups. Participates in the expeditious transfer of products and technologies by providing scientific knowledge and assistance. Provides technical advice/guidance and serves as a role model for junior scientific staff

101

Principal Scientist, Discovery Immunology Resume Examples & Samples

Working independently, manage and mentor scientists doing cutting edge research, design experiments, interpret data, troubleshoot and suggest next steps, detail-oriented with strong organizational skills
Collaboratively work in a matrix environment, present ideas, both verbally and in writing to diverse audiences including scientific colleagues and senior leadership
Drive collaborations, internally and externally, with scientists from different disciplines to drive value
Work in a collaborative environment where ideas can be respectfully challenged to drive excellence and innovation
A PhD in Immunology/pharmacology or related scientific discipline with at least 5 years of pharmaceutical industry or academic experience is required
Experience in either IBD and/or running discovery projects is required
Solid background in Immunology/Pharmacology is preferred
Strong understanding of IBD disease pathophysiology is preferred
Ability to manage people and projects (softer leadership is required)
Small molecule drug discovery is preferred
Experience in intestinal epithelial and immune cell homeostasis and the microbiome is preferred
Experience with development of complex cellular systems to mimic aspects of human disease and uncovering novel biology relevant to human immune-mediated diseases particularly IBD is preferred
Experience leading and advancing drug discovery programs, particularly small molecules, in immune-mediated diseases is preferred
Up to 10% travel is requiredBiology

102

Principal Scientist Resume Examples & Samples

Identify and lead new technology development projects within microbiology and environmental monitoring to ensure a state of global excellence is maintained to ensure long term commercial success
Identify gaps within our regulatory packages and work with management to identify resource requirements and project manage the studies to remediate
Global harmonisation representative for Microbiology and environmental monitoring
Review of Study Protocols and Reports for Assay Qualification and Validation studies and ensure that studies are delivered to the appropriate scientific and technical quality
Ensure development of technical and scientific skills of junior staff to maintain quality of analytical activities delivered to internal and external Customers
Presentation of scientific activities to Customers and at conferences to promote Lonza scientific integrity as required
Representing the Department to Customers as part of a Multi-disciplinary Project Team
Microbiological method development, optimisation and validation to support product QC testing packages
To provide scientific mentoring and training in all aspects of microbiology and to provide scientific oversight and guidance to scientists for troubleshooting of analytical issues
To evaluate, develop and introduce new technologies
Extensive experience in the field of microbiology and environmental monitoring within the pharmaceutical industry
Demonstrated experience of the development and validation of microbial techniques for testing of in-process and final product samples
Report writing, review and management sign off experience to maintain scientific integrity within the department
Proven ability in working with and presenting to customers on a variety of scientific subjects
Proven ability to deliver projects to agreed timelines and resource plans
Experience of working for a contract research or manufacturing organisation
Experience in Quality by design and risk based analysis

103

Principal Scientist Dmpk Resume Examples & Samples

Provides strategic and hands-on leadership relating to DMPK (including PK and in vitro ADME), to address absorption, metabolism and pharmacokinetic issues for small molecules and biologics
Independently conducts PK and PK/PD analysis during late stage lead optimization through early pre-clinical development, and collaborates in PK/PD and efficacy study design to support clinical dose setting
Ensures strong alignment and interfaces with DMPK groups across US affiliates and Japan Discovery and Development
Provides leadership to enable project teams to make maximally informative decisions regarding selection and stage up of discovery compounds for pre-clinical development in , Immunology and CNS areas
Formulates and executes research goals; recommends, designs, and/or executes experiments, utilizing a wide variety of scientific principles and novel methods to solve challenging scientific problems across multiple projects
May serve as co-leader on TCAL cross-functional drug discovery programs or on global working groups as required
Protects TCALs intellectual property and grows its external presence through an ongoing commitment to the production of high quality patents, presentations, and publications
Deep expertise in DMPK of both small molecules and biologics, knowledge in PK/PD/E modeling and application to clinical dose setting and predicting human efficacious dose
Software proficiency in Phoenix and/or Watson, GastroPlus is desired
Possesses scientific strategic thinking; decisions will result in critical effect on the Company's long-term success

104

R&D Principal Scientist Resume Examples & Samples

Leads and co-ordinates activities on scale up, in preparation for registration or process validation at Galway site or other nominated internal or third party site
Minimum of a scientific Bachelor's degree (Engineering/Physics/Chemistry/pharmaceutical sciences) with 8+ years’ experience in the development or manufacturing of sterile products. Additional postgraduate qualifications are advantageous
Must possess process and manufacturing knowledge of Injectable processes (Aseptic and TS) for a wide range of products (Solutions, lyophiles, suspension’s, controlled release injectable dosage forms) with experience of having multiple complex products approved with successful scale up for launch. In addition, expertise is required in application of QbD principles to process development activities

105

Principal Scientist Resume Examples & Samples

Directs overall pharmacometric project strategy and coordinates modeling activities across projects. Designs, performs, and oversees pharmacometric analyses using a variety of tools and approaches and in collaboration with internal and external partners
Creates, advocates, and implements innovative program strategies while maintaining and enhancing technical and drug development expertise
Interacts with project teams and therapeutic areas to proactively contribute expert input into model development, assuring rapid and effective communication of results
Possesses in-depth understanding of biology relevant to model development
Selects and collaborates with external partners/CROs
Maintains state-of-the art knowledge of relevant modeling approaches and techniques
May mentor junior associates
PhD with a track record of productivity in the areas of pharmacometrics, disease progression modeling, computational biology, or related field, as demonstrated by publications and presentations
Superb skills in collaboration and communicating both verbal and written technical and non-technical information, as appropriate
Modeling and computational experience, with excellent hands-on scientific computing and programming skills in a variety of computational tools such as MATLAB, Monolix, NONMEM, Mathematica, R, PFIM, STAN, and excellent working knowledge of Linux and Windows environments
Modeling, pharmacometrics, and computational experience
Solid understanding of PK and quantitative pharmacology principles
Knowledge of biological pathways relevant to disease and application to model development in different therapeutic areas
Excellent team work and superb skill in communicating information in both technical and non-technical terms in a multidisciplinary environment
Expert knowledge of biological pathways relevant to disease
Experience in drug discovery/development, especially in quantitative aspects such as PK-PD, pharmacometrics, or clinical pharmacology
Experience in working with internal and external teams to develop projects
Experience in working with rare diseases and/or oncology

106

Principal Scientist Resume Examples & Samples

Perform analytical method development, validation and transfer according to cGMP and ICH guidelines
Perform routine process support tasks
Maintain and troubleshoot analytical instruments
Understands and works in compliance with all cGMP, OSHA and safety regulations, BOPs and SOPs
Establishes and maintains priorities for work in support of project objectives
Clearly communicates timely reports of experimental work as needed to meet project objectives
Recommends and implements creative approaches to processes supporting project objectives
Accurately records and reports experiments and scientific findings
Participates in discussions and exercises good chemical judgment to help establish valid scientific direction on projects
Maintains work environment and technical communications within the framework of OSHA, cGMP, and safety regulations

107

Senior Scientist / Principal Scientist Resume Examples & Samples

PhD degree in Animal Science, Quantitative Genetics, Statistics, Bioinformatics, or similar field
Strong understanding of statistical methods and tools used in estimation of breeding values, especially single step methodologies, and genome-wide association studies for production, reproduction, health, and other economically relevant traits in livestock species
Excellent programming skills and experience in Fortran90, Perl, C, C++, C#, and/or Java in a Unix/Linux environment
Experience in working with databases and large data sets
Experience in using DNA markers for genetic evaluation
Strong communication skills- both verbal and written
Ability to work collaboratively with diverse personalities
Comfortable working in a rapidly changing environment
Self-motivated and ability to work independently

108

Principal Scientist Resume Examples & Samples

Serve on cross-functional project teams to represent Analytical supporting Small Molecule products
40% Analytical Subject Matter Expert (40%)
Serve as technical lead for laboratory-related investigations and provide support for process investigations as needed
In-house technical expert for drug product testing and methodology
Ensure that new or existing functional projects are implemented in a timely manner, and meet requirements for quality, cost and customer service
Directly support other Analytical staff members to assure technical aspects of all projects, initiatives, and activities as needed
Coordinate technical documentation, ensuring accuracy, clarity, and quality. This includes protocols, test reports, stability reports, technical reports, SOPs, etc
Maintain knowledge of current analytical and laboratory practices including a current understanding of USP/EP, cGMP regulations, ICH and FDA Guidance Documents
Maintain a current understanding of FDA guidance documents pertaining to laboratory operations, specifications, stability and analytical method validation
10% Communication (10%)
Lead and / or facilitate meetings and provide progress tracking and updates to leadership
Applies expert knowledge of scientific/technical principles & concepts
Must have method development experience and extensive troubleshooting skills and experience
Has broad and extensive understanding of analytical techniques and testing methodologies
Experience working with 3rd party contract manufacturing and laboratory sites
Lean six sigma, DOE, and statistical skills and experience desirable

109

Principal Scientist Resume Examples & Samples

To ensure the plant meets its customer quality, service, regulatory, financial and safety goals through effective leadership, support and management improvement projects across the Longford Site and at Division level
Maintain ETMS TO DO LIST
Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well at the Abbott Global and Technical standards
Lead and manage product improvement team(s) at the Longford site from a Technical perspective
Support and lead the technical aspect of design transfer activities and new product launches as required. Understand the design transfer process and be knowledgeable on all transfer products under your remit
Identify and communicate any project related technical issues to line manager and Senior Management Team and develop contingencies as applicable
Effectively balances compliance risk and business risk to create and approve risk management files as required
Optimize the use of human resources by encouraging an atmosphere of knowledge sharing, open communication and effective teamwork
Demonstrate an understanding of the application of the Quality Policy through daily activities. Bring to the attention of the Technical, Quality and Operations Managers in areas of risk in the production or Quality Systems operations which might have an adverse effect on product safety or quality
Ensure that the plant meets the quality requirements of its customers, internal quality systems, internal & external auditors and other external agencies
Ensure applicable GMP and GLP requirements are maintained
Supervisor Responsibility
A Bachelors of Science degree or higher in a relevant Chemistry or Life Science discipline as this will provide an understanding of the scientific principles required to understand the manufacturing processes and the skills required to record and analyse data from process testing or laboratory experiments
Two years’ experience in the development, design transfer or manufacturing support of diagnostic assays
The Principal Scientist is responsible for supporting strategic projects and base business activities from a technical perspective
Decision making within confines of annual performance goals
Review and feedback occurs via periodic goal reviews, annual performance and career development reviews

110

Principal Scientist Resume Examples & Samples

Works on highly complex problems where analysis requires evaluation of factors of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria. Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. Considered an internal leader in his/her technical field
Conducts AR&D activities required for the timely completion of feasibility studies for new pharmaceutical products including: solubility and suspension studies, particles size and sedimentation studies, temperature cycling studies, excipient and gel compatibility studies, accelerated kinetic studies/
Carry out AR&D studies resulting in successful timely pilot scale manufacture of new pharmaceutical products including: accompany customers in monitoring their pilot batches, prepare pilot batch documentation, ensure availability of raw materials, supervise pilot batch manufacture, ensure that pilot batch is manufactured under cGMP's, carry out and monitor in-process controls and drying studies, complete batch documentation
Oversee and assure the successful timely scale-up and transfer of Analytical Methods, in to and out of AR&D Somerset
Serve as primary scientific liaison with the customer on assigned projects
Be an effective Project Leader for designated projects
Together with supervision, determine general development approaches to be utilized for assigned projects, then plans and executes development work independently with minimal supervision
Coordinate with AR&D, Pilot Plant, QC, QA, and other groups, activities necessary to ensure project requirements are met
Prepare CMC sections, technical and verbal reports and presentations on project progress as well as specifications, procedures, and SOPs
Keep abreast of scientific literature which may have relevance to PTSC technologies
Performs other miscellaneous technical and administrative duties are required to meet company objectives
Comply with Health, Safety, and Environmental responsibilities for the position
Other tasks as assigned
10-12 years experience in AR&D focused on Drug Products and Drug Substances
Expert knowledge in scientific principles and concepts. Experience in Analytical Research and Development, on pharmaceutical compositions preferred. Exposure to computer software associated with word processing and spreadsheets desirable

111

Principal Scientist Resume Examples & Samples

Champion the use of translational imaging (mainly PET, SPECT) in drug programs and align imaging activities between discovery and clinical development
Work closely with clinical project teams and discovery teams by providing high quality scientific inputs into imaging methodology of relevance for cancer immunotherapeutics
Design innovative imaging studies that can provide unique pharmacokinetic and pharmacodynamic information and contribute to decision-making
Work with project and study teams to support the implementation of imaging endpoints in clinical studies, ensuring establishment and sharing of best practices and processes
Function as an integrated member of the imaging sciences group, align with the strategy, provide guidance on imaging tools and ensure good communication and collaboration with imaging expert peers
Contribute to the team’s effort to increase awareness of the potential of imaging within Oncology, by presenting at internal seminars and scientific forums
Participate in selecting imaging centers of excellence for the establishment of collaboration agreements on methodology development/innovation and exploratory imaging studies

112

Principal Scientist Resume Examples & Samples

Functionally reports to the Global Head of Immuno-Oncology Biomarker diagnostic Center of Excellence (IO-CoE). Operationally reports to the OPM IO Director
Responsible for identifying, prioritizing, and recommending key IO biomarkers and diagnostics applicable to Novartis IO assets
Responsible for executing feasibility biomarker and diagnostic studies to support Novartis IO assets
Identifying critical signaling pathways and mechanisms of actions associated with IO therapy response and resistance that are common and unique across indications
Lead the harmonization of IO biomarker testing across indications
Support Precision Medicine Directors and Associate directors in the development of biomarker plans
Support the creation of biomarker/CDx portions of key IO clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs)
Supports regulatory submissions by acting as subject matter expert within the team. Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents (including NDAs, IDEs & PMAs). Coordinates data requirements with reference labs to support submission
5+ years multi/cross functional experience within an Oncology business unit
Expert management and communication skills to coordinate cross-functional projects
Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration
Outstanding verbal and written communications
IVD development experience is an advantage

113

Principal Scientist Resume Examples & Samples

Publishing and presenting study findings
Providing strategic consulting and expert witness work
M.S., M.P.H., or Ph.D. in Public Health, Epidemiology, Toxicology, Industrial Hygiene, Environmental Science or related field
Minimum 15 years of related experience
Minimum 5-10 years of consulting experience
Strong writing and verbal communication skills
Demonstrated project management experience
Ability to work independently and as a member of a team

114

Principal Scientist Resume Examples & Samples

Map, contribute to and implement an overall nonclinical program strategy to support clinical candidates of all stages of drug development
Design, implement, report and interpret nonclinical study data to support small molecules and biologics in late-stage research and all stages of nonclinical/clinical development
Prepare study proposals, protocols, study reports and regulatory documents to support nonclinical development of BioMarin drug candidates
Interact with regulatory regions (i.e. FDA, EMEA, MHRA, ROW)
Managerial responsibilities include supervision of Pharm/Tox scientific staff and team development
Interact with CROs, university laboratories, analytical laboratories, collaborators, both internal and external to BioMarin, as necessary to ensure appropriate/timely progression of BioMarin nonclinical projects
Collaborate with various BioMarin departments to ensure efficient cooperation with outside laboratories and regulatory agencies
Participate in multi-disciplinary drug development teams and lead sub-teams
Ability to build and foster productive cross-functional collaborations both within and external to BioMarin
Nonclinical pharmacology/toxicology background and 10+ years of experience in the pharmaceutical, CRO, and/or biotechnology field
Strong understanding of drug development and regulatory process, as well as a strong understanding of Good Laboratory Practices (GLPs)
Experience supporting the development of small molecules, biologics and/or other therapies, including determining non-clinical program strategy and design
Experience in the design, conduct, and interpretation of GLP and non-GLP nonclinical toxicology studies

115

Principal Scientist Resume Examples & Samples

Utilize integrative approaches including literature search, data-mining, system biology and translational medicine research to identify and nominate immune modulation-based new therapeutic concepts (NTCs)
Formulate and execute on research plans to enable the validation of such NTCs, including independently designing and performing scientific experiments towards such goals, as well as leading project teams
Assumes responsibility for direct reports as needed including recruiting, managing, mentoring and developing scientific staff. Direct, oversee and mentor experimental design, data generation and interpretation of junior level research scientists
Prepare and review clear and accurate technical and research reports for internal and external use. Prepare and deliver scientific presentations for internal/external use, including providing project status updates to senior research leadership team
Collaborate extensively with other members of the Immune Modulation Group in Ridgefield and globally, the larger BI’s Global Immune Modulation Biotherapeutics Discovery (IMBD) Division. as well as with members of other BI research entities such as the Inflammation & Respiratory therapeutic area. Will be responsible for establishing and managing productive collaborations with outside experts
Contribute to the greater good, including departmental administration, scientific culture, and technical evaluation of in-licensing opportunities

116

Principal Scientist Resume Examples & Samples

This position is responsible for validation activities in a cGMP / CBER regulated medical device manufacturing environment. As a member of the Design Transfer and Technical Support Team, this position will participate in Process Validation activities for new product transfers prior to commercialization and process improvements for on-market products
This candidate will be responsible for preparing, reviewing and/or approving validation documents to support new product launches and any changes to existing validated processes for regulated on-market products. These validations may include the manufacturing and filling processes for bulk reagents (large and small scale) and for production intermediates such as Oligonucleotides, Control Stocks and Enzymes as well as the manufacturing equipment cleaning processes
Duties include the preparation and technical review and approval of validation documents such as plans, protocols and reports, analysis of data, and developing validation strategies in accordance with industry guidelines and SOPs. This position must be able to lead validation deliverables / projects, manage multiple competing timelines and priorities and work in a cross-functional team

117

Principal Scientist Resume Examples & Samples

Coordinates all aspects of managing / method development and validation and specialty service areas within the division
Supervises and assists senior technical staff in laboratory operations such as scheduling, resource management, technical and compliance related issues
Interfaces with clients on scientific issues, study design and project technical requirements
Plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity, quality and technical expertise in the laboratory
Assists division director in strategic planning, business development and new technology implementation
Min. requirements need to read: Education and Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years’) or equivalent combination of education, training, & experience. OR
Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 10+ year)
Excellent technical capabilities with analytical expertise in method development and/or specialty technology
Ability to drive implementation of new systems or enhance existing ones
Strong organizational agility and demonstrated drive for results

118

Principal Scientist Resume Examples & Samples

Provide technical leadership on developing materials scale up and optimization for new product development
Expertise in surface modification scale up process
Provide technical leadership on material scale up and process development with quality control
Ability to work with material toll manufacturer to transfer material scale up with process control, validation
Technical knowledge about polymers and materials and methods of incorporating and applying novel materials on membrane
Interacting directly with developing team to understand true needs, performance specifications and product performance evaluation, and needed QC methods
Ensuring successful transfer of developed processes to developing teams
Proficiently apply design of experiment (DoE) on process development
Driving key aspects of complex new product development through the R&D funnel
Provide technical training and development to cross functional developing team in areas of technical operations to transfer technology from research phase to development phase
Ability to work on multiple concurrent projects
Performing root-cause analysis and problem solving of complex problems
Championing effective project practices, documentation and reviews and provide process quality controls
The candidate will be expected to work independently, manage projects, and Working and influencing amongst a cross-functional team
Strong verbal and written communication skills are integral to this position
Deep understanding of materials characterization techniques
Experienced in managing multiple projects and working with multifunctional teams
Strong planning and organization skills
Strong leadership experience is preferred
Knowledge of creating and using project management tools is a plus
PhD in (material science, polymer science, chemistry or chemical engineering) with 3+ years of industrial R&D experience
5+ years of hands-on experience in process development
5+ years of experience with understanding of materials characterization techniques
5+ years of experienced in managing multiple projects and working with multifunctional teams

119

Principal Scientist Resume Examples & Samples

Lead a team of senior research associates and scientists responsible for high throughput and automated methods development for in-process analytical support testing
Work with the team to develop new in-process analytical assays; improve existing methods; transfer current low throughput assays onto high throughput platforms
Provide technical support and hands-on training for new assay development in LC-MS/MS analysis, HPLC/UPLC, CE-SDS and cIEF and immunology-based assays
Develop a high level of employee engagement; mentor and train direct reports at varying levels of experience. Sets clear priorities for achieving results and empower the team to develop independent thinking skills
Coordinate with management to plan workload and resources to meet project timelines and customers’ expectations
Functions in a leadership role within Bioprocess Analytics; assists in planning and project activities for Bioprocess Analytics. Manage priorities, and maintain timelines for multiple projects
Contribute to documentation and preparation of reports and scientific presentations; participate in delivering scientific presentations at internal and external meetings
PhD in Analytical Chemistry, Biochemistry or related field with 6+ years relevant experience in Bioprocess Analytics environment. Previous management experience is required with a minimum of 3 years managing teams
In-depth and broad knowledge in bio-analytical/analytical methods and immunology-based assay development platform technologies for protein characterization. Hands-on experience with mass spectrometry, HPLC/UPLC, CE-SDS and cIEF. Familiarity with qRT-PCR and biomolecular interaction assays, e.g. automated immunoassays, such as Octet and Gyros platforms
Proven track record as a leader with experience managing highly technical teams and building high performance teams
Experience in analytical methods development and qualification of therapeutic proteins, following ICH guidelines for the characterization
Knowledge of Process Analytical Technology (PAT) and development of at-line, on-line and in-line methods for process monitoring for downstream process monitoring is highly desirable
Highly independent, driven, self-motivated and innovative thinker. Ability to work successfully in both a team/matrix environment as well as independently is essential
Excellent written, verbal communication and presentation skills

120

Principal Scientist, Sequencing Resume Examples & Samples

Conceptualize and lead the definition of novel assays and clinically-focused applications for the Genia Sequencing Platform
Provide technical direction and guidance to optimize platform performance in terms of yield and sensitivity across a broad range of sample inputs and sample types
Lead the development of reagents and workflows under GMP and regulatory environments

121

Principal Scientist Resume Examples & Samples

Develop and manage a group of associate scientists with expertise in assays measuring bacterial/fungal phenotypic changes or growth inhibition, inhibition of viral replication and virus neutralization
Provide functional expertise in the areas of anti-infective assay development and execution
Identify, validate and integrate new technologies or methodologies, as needed, to address questions related to drug discovery programs and projects
Set goals and objectives (e.g.,program/project goals and development of new capabilities) in collaboration with supervisor and key stakeholders
Align and manage team members and reports to execute on departmental priorities
Optimize efficiency and productivity (e.g., cycle time, innovation, financial stewardship, communication and collaboration) through effective management of work flow
Evaluate outsourcing options and design work plans as appropriate
Represent Pharmacology on program teams and provide input on the design of the program’s research operating plan and strategy
Ensure timely communication and delivery of high-quality in vitro data to Therapeutic Area program teams
Collaborate with other Pharmacology groups to provide the required support for drug discovery programs
Experience in antibacterial, antifungal drug discovery; experience managing associate scientists
Ability to understand and implement applicable regulations regarding the use of pathogens (e.g. virus, bacteria, fungi), human cell and tissue use, laboratory safety, health physics and chemical hazards in research
Experience in the design, development and execution of in vitro assays for anti-infective drug development programs targetting antivirals, antibacterials, antifungals, and/or vaccines
Experience in the drug discovery and development process from screening through clinical candidate identification
Strong collaborative skills
Experience in the management of associate research scientists
Skill in troubleshooting experimental design, assay development and data analysis
Knowledge of anti-infective drug targets and the context of pharmacologic intervention

122

Principal Scientist Resume Examples & Samples

Minimum of 8 years of experience post-PhD including significant industry experience in the Discovery of Biologics Therapeutics and a strong record of peer reviewed publications/patents
Hands-on experience of mAb generation and Protein Engineering using display technologies including phage display
Experience with the de novo generation of recombinant antibody libraries
Experience in managing and mentoring non-PhD scientists

123

Principal Scientist Resume Examples & Samples

Provide technical expertise to External Manufacturing in ensuring consistent production of J&J marketed pharmaceutical products manufactured by third party manufacturer
Act as a technical co-coordinator and consultant to the external manufacturing group for the technical scouting and due diligence for the current product portfolio existing in external manufacturing
To lead the Technology transfer activity of drug products in Asia Pacific Region as per regional Guidelines & J&J Quality Standards according to approved budget and timeline
At least two years’ experience in Third Party Technology Transfers and project management is desirable
Profound understanding of

124

Principal Scientist Resume Examples & Samples

In-depth knowledge of fundamentals of immunology, immuno oncology, and tumor biology in solid and hematological malignancies
Utilization of translational based approaches to develop new concepts and mechanism of action hypotheses identifying distinguishing characteristic of Celgene compounds alone and in combination with other therapies
Design and execution of primary immune cell based assays
Manage internal projects in immune oncology drug development
Ph.D. degree in immunology, tumor biology or cellular biology, or pharmacology with at least 3 years of successful post-doctoral experience, evidenced by a strong publication record, plus a minimum of 10 years of successful experience as a scientist preferably in the biotechnology or pharmaceutical industry setting
Effective team building and teamwork skills and ability to interact with and manage research scientists, project teams, outside collaborators and commercial vendors

125

Principal Scientist Resume Examples & Samples

Drive development of cell culture media area within the organization
Representing the department and the cell culture domain in strategic processes within GEHC, working closely with Marketing and Product marketing to provide scientific, technical and business input
Build and maintain an external network covering customers, technology and science
Build and maintain good knowledge of competitors and competing products/technologies
External visibility by oral and poster presentations at external conferences and/or by publishing papers in scientific journals
Actively work to network and contribute with know-how across the Life Sciences R&D organization
Driving elements of the multi-generational product plan as well as product specific development plans
Multi-generation segment technology planning and rationalization experience with an excellent understanding of product system architecture(s), platforms and core technologies
Influencing strategic development of global product roadmaps with a focus on technical differentiation that addresses key customer needs
Influencing segment leadership and segment direction through action-oriented recommendations based upon market, competition, and technology
Serving as a technical readiness focal point for all pertinent personnel and/or customers
Coaching and mentoring in order to develop the engineering community in process, career growth and technical excellence
PhD or similar competence in Biotechnology or related area
12 years progressive experience as an engineer or scientist within the appropriate field of study
Extensive experience from Industry work in Upstream area, and with focus on Cell culture media development and cell culture optimization
Demonstrated experience driving technology and segment planning processes with a focus on differentiation and financial return
Demonstrated ability to influence and drive segment direction utilizing internal and external resources on segment initiatives
Demonstrated strategic planning with experience in driving technical changes across a segment of products
PhD Degree in Engineering or equivalent (defined as 12 years progressive experience within engineering, science, or related field, including 5 years project leadership experience within manufacturing, development, or research development)
7 years project leadership experience within manufacturing, development or research environment
Strategic planner and thinker with ability to drive change across the segment products
Sound technical and domain experience in at least one functional technology area
Demonstrated experience on global product releases throughout the entire NPI cycle
Demonstrated LEAN skills

126

Principal Scientist Resume Examples & Samples

Develops strategy and research plans; designs, executes and interprets experiments to determine mechanisms of drug efficacy, mechanisms of resistance, rational combinations, new indications, and product differentiation
Supervises research scientists in the lab
Responsible for the development and delivery of biomarker components of Celgene clinical trials, including protocol development, translational plans, and regulatory documents
Analyzes biomarkers for Celgene clinical studies by working with relevant functions and CROs; responsible for creating SOWs and interfacing with CRO for execution of services
Authors study reports, biomarker components of clinical protocols, patent applications, regulatory submissions and peer-reviewed publications
Reviews external preclinical proposals and correlative study components of investigator initiated trials
Represents Translational Development at project/franchise teams
Contributes to the development of yearly budget
Communicates regularly; prepares and delivers presentations within the department and externally
Ph.D. in life sciences or medical sciences, and a minimum of 8+ years of directly relevant biotechnology or pharmaceutical industry experience
Broad understanding of oncology drug discovery and development, especially late stage development
Comprehensive knowledge of tumor cell biology; experience with hematological malignancies a plus
Knowledge of clinical biomarker discovery, development and analysis, including drug mechanism research, assay development/validation, and extensive knowledge of platforms
Working knowledge of cell-based, molecular and in vivo pharmacology models used in cancer biology
Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
Accurate and detailed record keeping
Coordination of external collaborations and contracted research
Effective people manager, with team building and teamwork skills

127

Principal Scientist Resume Examples & Samples

Manages, records, and presents data: Accurately and consistently recording experimental method, materials, and results in eLN. Analyzing data, forming conclusions, and determining future experiments. Presenting findings or comprehensive project status reviews at internal meetings. Applying advanced technical writing skills to produce reports and documents such as summaries, SOPs, DHFs, presentations and manuscripts
Has expertise in Biochemistry and Molecular Biology: Strong background and strong technique skills in biochemistry and molecular biology. Familiar with PCR, Microarray, and/or NGS technology. Good understanding of bioinformatics and biostatistics
Manages people: Positions with people management responsibility have full HR responsibility for direct reports and/or indirect reports

128

Principal Scientist Resume Examples & Samples

PhD. in Chemistry, Food Science or a related field with 5-year experience in flavor chemistry and reaction flavors. MS with commensurate experience will be considered
Knowledge of sensory and analytical chemistry is a plus
Must possess strong interpersonal and communication skills demonstrated by the ability to positively influence others
Demonstrated ability to manage priorities and multi-task

129

Principal Scientist Dmpk Resume Examples & Samples

Candidate should possess good understanding of pharmacokinetic, pharmacodynamic principles and drug development
Experience with clinical data sets and clinical data analysis
Strong written and oral communication skills and interpersonal skills are essential
Represent DMPK as the subject matter expert for preclinical and clinical DMPK on project teams
Responsible for the analysis, interpretation, integration and reporting of preclinical and clinical PK data generated both internally and with external vendors/academic sites
Review and interpret bioanalytic data and reports
Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo ADME and PK modeling studies
Lead and prepare PK preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures
Perform pharmacokinetic-pharmacodynamic modeling to aid decision making on programs
Prepare strategic and scientifically sophisticated PK drug development strategies that meet regulatory requirements and program goals
Author high quality Regulatory documents including INDs, CTAs and NDA filings
Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
Participate in the preparation of abstracts and manuscripts for publication

130

Principal Scientist Resume Examples & Samples

Strong knowledge of methodological approaches and technical aspects (study design, data analysis and interpretation) of COA development, validation, electronic migration and interpretation into clinical trial and observational studies
Able to develop strong internal relationships with cross-functional teams
A track record of COA-related scientific presentations and publications
Understanding of current and evolving PRO/COA measure requirements for regulatory labeling claims (e.g. FDA and EMA) and HTA/reimbursement (e.g. NICE and IQWIG)

131

Principal Scientist Resume Examples & Samples

Design and implementation of biomarker strategies in multiple early clinical and preclinical stage programs through close collaboration with the Clinical Biomarkers, Fibrosis Discovery, Biomarker Technologies, Genomics, Informatics and Biostatistics groups and clinical and pre-clinical project teams
Contribute to the implementation of the Discovery TR&D strategy by developing/validating translational/biomarker assays/models in collaboration with in vitro and in vivo scientists in the TR&D group and the project teams
Build relationships, establish and manage collaborations with key external stakeholders including academic and clinical collaborators and CROs
Analyze, review and interpret biomarker data sets and author relevant documentation
Engage in critical analysis of novel biomarker and analytical approaches and technologies
Lead early eTR&D projects
PhD in cell biology, pharmacology or other relevant scientific area with at least 10 years of research experience in the Pharmaceutical/Biotech industry and Academia
Demonstrated experience in translational research and biomarker discovery
Working knowledge of the state of the art technologies used in clinical biomarker discovery and analysis
Laboratory experience including biomarker assay development and validation
A demonstrated understanding of the early clinical drug development process is highly desirable
A strong understanding of fibrotic or related mechanisms and signaling pathways and of in vivo fibrotic or related models is desirable
Excellent written and oral communication skills with the ability to articulate complex scientific concepts to diverse functional groups and external stakeholders
The ability to work in cross-functional matrix teams
Strong peer-review publication record
1604927

132

Principal Scientist, Sequencing Resume Examples & Samples

Highly multiplexed experiment design and execution
Performance of molecular biology techniques: PCR, electrophoresis and primer design
Operating genomics platforms and instruments

133

Principal Scientist Resume Examples & Samples

Product Design
Independently, design and initiate studies to support prototype development, process development, scale investigations, and product chemistry evaluations to facilitate new product development
Lead transfer of manufacturing technology to both internal and 3rd party manufacturing facilities
Incorporate the principles and practices of Quality by Design (QbD) into development projects
Perform data collection and analysis, discuss conclusions regarding progress of work, and effectively communicate information to leadership in the form of discussions, reports and presentations
Author protocols, reports, and other technical documents as part of the product design and technology transfer process. Author documents for regulatory submissions. Document all experimental work performed in an e-notebook
Design and execute developmental stability programs to assess viability of dosage forms
Lead multi-disciplinary project teams. Collaborate with project team members to ensure that critical project milestones are achieved. Use innovative approaches to help resolve project issues while minimizing impact to project timeline. Maintain project budget for product design activities
Lead multi-disciplinary strategic technology roadmap teams to help ensure a robust innovation pipeline for core brands
Act as a subject matter expert in areas of deep knowledge and expertise. Provide guidance and advice to help resolve technical investigations. Present technical information in open forums
Evaluate, both individually and as a member of roadmap teams, new ingredients/equipment/technologies and assist in making recommendations to support core products, product improvements and/or line extensions. Aggressively pursue intellectual property and patent applications
Solve problems using multiple problem-solving tools and techniques using appropriate resources, personal knowledge, experience, and available data, with emphasis on Design of Experiments process
Present information on issues to leadership with recommendations on next steps
Organizational and Talent Development
Assist in training junior level staff and guide the work of these individuals on the development team
Up manufacturing, process capability studies, pre-validation activities, laboratory and stability

134

Principal Scientist Resume Examples & Samples

30% Leverage customer insights, strategic direction, consumer trends, unmet needs and deep understanding of Cargill capabilities to identify and drive R&D opportunities in the bakery space
20% In conjunction with Sales and marketing counterparts, develop and co-own execution of Customer Development Plans (CDP’s) across bakery customer base. Develop and maintain deep customer relationships and drive all customer pull product development projects from bench through commercialization, leveraging cross functional resources as needed to identify/deliver and qualify Cargill solutions. Provide technical support and service necessary to ensure effective customer implementation
20% Deliver results against assigned market forward opportunities from bench through commercialization and facilitate implementation at customer locations
20% Deliver results against “Partner of Choice branding by providing exceptional technical service and support across internal & external customer base, including general troubleshooting, quality issue resolution, processing/application concerns and technical training
5% Support technical training and professional development of team members
5% Foster and promote the Cargill GEOS brand through representation at industry meetings and active participation in industry/trade organizations as assigned
Travel approximately 40%
Four-year undergraduate degree in a related scientific discipline, such as food science, chemistry, food technology
Demonstrated track record of developing and cultivating relationships within an organization
10+ years of Food Industry experience in a product development or technical service role
Experience engaging with customers and delivering technical solutions
Demonstrated track record of effective cross-functional partnerships
Demonstrated teamwork and the ability to effectively lead and collaborate with others
Demonstrated ability to influence others outside of formal reporting relationships
Effective oral, written, presentation and communication skills
Advanced degree in a related scientific discipline, such as food science, chemistry, food technology
15+ years R&D or technical service experience in fats and oils
Bakery experience
4+ years customer interfacing experience
Demonstrates practical business acumen and ability to monetize R&D projects
Demonstrated ability to teach and coach others
Experience in solution formulation and plant scale-up

135

Principal Scientist Resume Examples & Samples

Applying functional area knowledge to frame critical drug development questions for optimizing model-based drug development
Maintaining, and helping others develop and maintain, a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
Scientific and/or supervisory oversight of a group of scientists
The educational and experience requirements listed above are required

136

Principal Scientist Resume Examples & Samples

PhD preferred or MS/BS in Chemistry /Pharmaceutics with related science experience
Education: PHD preferred or MS/BS in Chemistry /Pharmaceutics with related science
Experience: 5-10 years of experience in the formulation development or analysis of topical or liquid dosage forms, i.e. solutions, suspensions, emulsions, micro-emulsions, etc. is essential
Experience with medical devices is helpful but not essential
Knowledge/Skills: Expert knowledge and application of scientific principles and techniques
Mathematical and reasoning ability. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to work with colleagues and multiple clients in a professional and organized manner, and interact effectively with a variety of people from different nationalities, ethnic/cultural backgrounds, and educational levels
Ability to organize and prioritize work with limited guidance and to manage projects in a timely and effective manner
Ability to reorganize and reschedule work on short notice in order to meet revised client deadlines
Manage and direct project team, including identifying, directing, and delegating tasks necessary for successful regulatory project completion

137

Principal Scientist Resume Examples & Samples

Possession of a Doctoral degree to include (e.g., D.V.M., D.Sc., M.D., Ph.D.) from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) appropriate to biomedical research
A minimum of eight (8) years of post-graduate experience including five (5) years of independent, competent, and innovative research in a field of specialty. Three (3) or more years of managerial experience is required
Extensive experience in histopathology techniques, including histology sectioning, special stains, immunohistochemistry, in situ hybridization, digital pathology and image analysis
In depth experience of tissue morphology of human tissue
Experience of line management of staff
National recognition of skills and publications in the field of histopathology, immunohistochemistry, in situ hybridization, digital pathology or image analysis
Experience of delivering highly complex scientific information to a broad range of researchers
Experience of negotiation and influence with researchers and specialist equipment providers
Ability to engage with a wide variety of stakeholders, including: academics (internal and external research group leaders and their teams), technical staff, government researchers
Experience of managing, training and mentoring staff to work effectively as a team to deliver scientific research programs
Experience of prioritization in a high pressure environment
Demonstrable active continued professional development
Expertise in MS Office suite and familiarity with using databases
Excellent organization skills with meticulous attention to detail
Ability to be proactive in problem-solving and strive to improve on established protocols or employ new ones

138

Principal Scientist Resume Examples & Samples

Provides leadership for employee relations through effective communication, coaching, training, and development
Manages scientific staff providing direction and advice with regards to execution of assigned projects
Assesses strengths and weaknesses of scientific staff making maximum use of the strengths while assisting in further development of weaknesses. Provides input and recommendations to performance reviews and career progression
Ensures staff acts in accordance with Johnson Matthey policies and practices with respect to GMP, environmental, health, and safety (EH&S) and other related regulatory requirements
Interacts with clients and helps the project team lead discussions during conference calls and meetings
Ensures efficient and timely execution of projects. Develops project scope and objectives in conjunction with appropriate teams. Opportunities are identified and evaluated, appropriate plans are developed in conjunction with other departments and continually assessed. Schedules, priorities, and available resources are well understood and considered in making decisions
Creates and tests new theories related to solving important problems within the scope of client projects. Such new theories are based both on scientific precedent and observed laboratory results and must be tested in well-designed experiments
Shares special skills and expertise with other team members
Manages compliance with state and federal regulations, including but not limited to GMP, DEA, and FDA
Understands and applies cGMP concepts in association with department specific responsibilities
Responsible for departmental audit readiness and for participating in audits with internal Company groups, regulatory agencies, and customers
Actively participates in root cause investigations on near misses and all incidents. Once identified, ensures corrective actions take place in compliance with Company policies and procedures, and all state and federal regulations occurs within the responsible department
Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc
Implements, applies and places emphasis on EH&S concepts with department specific responsibilities
Ability to mentor staff; assessing strengths and weaknesses, providing timely and in depth feedback on all aspects of performance and promoting JM cultural beliefs
Ability to lead projects and provide direction to various levels of BS Chemists and PhD Scientists
Effective communication with clients and direct reports
Experienced in designing, developing, and optimizing intermediate and API synthetic processes for scale up under GMP conditions using kilo-lab or plant equipment
Experienced in evaluating process safety and chemical hazards
Strong written and verbal, communication and presentation skills
Good understanding of Microsoft Office
Ability to plan, organize, and oversee multiple independent research programs
Ability to successfully work with interdepartmental teams
Knowledge of analytical techniques (HPLC, GC, DSC, FTIR, XRPD, TGA, , NMR)
Good understanding of crystal engineering and specialized purification techniques (SMB, prep HPLC)
Knowledgeable regarding the following areas: analytical method development, catalysis, and solid form crystallization
Experience in evaluating processes and writing proposals
Knowledge of MS Project. Experience in establishing integrated plans with resource and task constraints

139

Principal Scientist Resume Examples & Samples

PhD, MD or similar with minimum 8 years of relevant experience
Experience in Pharmaceutical/Biotech is highly preferable
Proven record supporting drug discovery with diverse histology approaches including confocal microscopy, is required
Expertise in quantitative and analytical histology
Experience with multiplex high throughput IHC approaches is desirable
Background in pathology of lung and liver is a plus
Ability to interact with multiple scientists and interdisciplinary teams and to prioritize and deliver timely precision data

140

Principal Scientist Resume Examples & Samples

Lead/collaborate with chemistry and multi-disciplinary teams to advance projects from lead generation to development candidate selection
Apply skills and knowledge to champion innovation in medicinal chemistry design and analog synthesis in the laboratory
Identify and implement strategies, tools, and technology for continuous improvement in small molecule lead optimization projects
Represent the chemistry function on global research project teams for the development of new small molecule therapeutics for veterinary medicine
Develop constructive relationships with both internal and external global partners and align team goals with organizational objectives
Coach and mentor chemistry colleagues and provide direction to contractors supporting the function
Excellent understanding of the drug discovery process from lead generation to development candidate nomination
Demonstrated ability to identify and solve complex problems independently to advance research in both synthetic and medicinal chemistry
Skilled in interpretation of complex biological and ADME data, medicinal chemistry design, multi-step organic synthesis, purification and compound characterization
Working knowledge of partner disciplines such as DMPK, in vitro and in vivo Biology, Formulations, Analytical
Experience with small molecule IP strategies and filings
Strong organizational skills to build and manage internal and external relationships
Effective influencing and oral/written communication skills, including the ability to communicate effectively to project teams and management
Ability to excel in a multi-disciplinary environment as a leader and member of project teams

141

Principal Scientist Resume Examples & Samples

Master Degree or PhD in Medical Science, Pharmacy or Nursing preferred
Minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in a clinical safety or regulatory affairs departments required
Minimum of 2-3 years of medical writing experience (Prefer experience in writing pharmaceutical reports such as PSURs, Clinical Study Reports, safety sections of the ISS and/or Common Technical Document, or white paper) and/or experience in Medical Surveillance and Risk Management
Proven understanding of clinical disease state and implications of treatment
At ease with data and statistics
Proven ability to communicate effectively (verbal, presentation at group meetings, etc)
Proven experience with project management (formal or informal)
Strategic thinking, organizational leadership, results-oriented performance, team player
Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines) and Risk Management
Excellent interpersonal skills, including ability to work effectively, cross culturally and cross functionally

142

Principal Scientist Resume Examples & Samples

Identify and isolate new plasma protein therapeutics
Ability to work at a computer and view video display terminal less than 18” away from face for extended periods - up to four (4) hours at a time
Ability to read and review documents for extended periods - up to four (4) hours at a time
Ability to sit or stand for extended periods - up to four (4) hours at a time
Ability to lift and/or move up to 25 pounds
Specific vision abilities required by this job include close vision, distance, color, peripheral vision, depth perception and the ability to adjust focus
While performing the duties of this job, the employee is occasionally exposed to toxic and caustic chemicals and frequently to biological hazards

143

Principal Scientist Resume Examples & Samples

Develops new biochemical and microbiological methods for testing Grifols products and process samples
Designs protocols for validating existing and new test methods and supervises execution of these protocols
Assists in the transfer of validated methods to the Grifols QC laboratory
Assists in developing and maintaining a schedule for the validation of QC tests for process intermediates and final product
Designs protocols for installation, operation and performance qualifications of new QC analytical instruments and maintains the schedule for completing these qualifications
Identifies resources, equipment and supplies that are required to perform validation of process intermediate and final product tests
Maintains system for timely purchase and qualification of laboratory equipment and reagents
Reviews and revises standard operating procedures for technical accuracy and compliance with regulatory requirements
Assists the QC department in troubleshooting or investigating instrument and assay problems
Provides information for internal and external audits on the GMP validation status of QC equipment, reagents and tests. Assists in the resolution of audit observations related to validations and proposes corrective actions
Notifies QC management of any potential quality issues related to test validations and provide recommendations for quality improvement
Ph.D. in Chemistry, Biochemistry, Physics or related Life Sciences field or closely related scientific/ technical discipline is required. Experience in laboratory method validation and familiarity with ICH and U.S. and European pharmacopeia guidelines for analytical methods validation is strongly preferred
Equivalency: In lieu of a Ph.D., candidate must have a Master's degree and a minimum of 5 years of related experience in a pharmaceutical, GMP, or FDA regulated environment. Experience in laboratory method validation and familiarity with ICH and U.S. and European pharmacopeia guidelines for analytical methods validation is strongly preferred
Requires a fundamental understanding of analytical methodology, protein biochemistry, immunochemistry, chromatography, electrophoresis, spectroscopy, and ELISA
Requires a familiarity with statistical methods for data analysis
Strong communication, interpersonal, organizational and decision making skills

144

Principal Scientist Resume Examples & Samples

At least 10 years of postdoc experience in modeling complex chemical and biology data in a drug discovery setting using advanced expertise in cheminformatics and machine learning
Knowledge and experience with statistical programming and scripting languages
Strong communication skills, along with the ability to work well in multidisciplinary teams, are essential.

145

Principal Scientist Resume Examples & Samples

Designs and conducts pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects
Independently plans and executes strategies for formulation development and solves complex problems
Conducts literature search for the projects including publications, patents, etc
Reviews and authorizes reports/documents such as product development reports, quality overall summary, master formulas and other key reports/ documents
Coordinates with other Actavis development and manufacturing sites
Provides technical assessments on alternative drug delivery technologies
Involves in process validation when needed
Involves in identifying analytical testing conditions along with Analytical Development
Organizes and procures materials and equipment for the execution of batches
Conducts briefings and technical meetings for top management and representatives
Represents Formulation Development and acts as subject matter expert with government agencies, e.g. FDA during PAI or in responding to deficiencies to submitted ANDA applications
Provide scientific advice and training to Junior Scientists
Participate in depositions during patent litigation
High level of technical Knowledge and Skills
Thorough understanding of pharmaceutical dosage forms including controlled release drug delivery technologies
Thorough knowledge of Good Manufacturing Practices
Knowledge of FDA regulatory guidances, ICH guidelines and requirements of ANDA submissions
Knowledge of DOEs and QbD elements
Strong organizational skills with the ability to multi-task and prioritize assignments
Working knowledge of patents, pharmacokinetics and biopharmaceutics
Working knowledge of Microsoft suite of software products including Excel, Word and PowerPoint, Mini-Tab or equivalent software packages for data analysis
Ability and willingness to work in a cross-functional team environment

146

Principal Scientist Resume Examples & Samples

A Bachelor’s degree with a minimum of 10 years of relevant work experience OR a Master’s Degree in Engineering with a minimum of 6 years of relevant work experience OR PhD with a minimum of 3 years of relevant work experience is required
A degree focused in Polymers, Biology, Biomedical, Chemical Engineering, Biomaterials Engineering or Materials Science is preferred
Experience working in a regulated industry is required
Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required

147

Principal Scientist Resume Examples & Samples

Uses knowledge of industry standards including AAMI, ASTM and FDA Guidance to provide strategic direction for the Reprocessing Program
Represents WuXi AppTec at industry conferences, trade shows and client meetings including AMDR
Leads client sponsored research related to Reprocessing of single use medical devices
Interacts with client to discuss project planning and testing requirements
Interacts with internal staff and management to identify assays requiring further improvements or development and oversees improvement of these assays
Facilitate communication between members of the study team and sponsor
Develop and maintain protocol templates for routine Reprocessing methodologies
Support Account Managers through attending conference calls and writing proposals
Work with multiple internal and external laboratories to ensure accurate and on-time project completion
Review final reports to ensure accuracy, consistency and professional appearance
Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
Ability to work in a team environment and independently as required
Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International. Standards, and WuXi AppTec Policies and Standard Operating Procedures
Bachelor’s Degree in related discipline or equivalent required, M.S. or Ph.D preferred
Minimum 10 years of experience in Life Sciences and/or Biotech environment
Strong knowledge medical device Reprocessing for single use and reuse devices
Demonstrated knowledge and application of cGMPs/GLPs, AAMI, ASTM & FDA Guidance Documents
Experience managing complex projects and meeting aggressive timelines
Experience as a GLP Study Director a plus
Ability to perform independent research
Strong organizational skills with attention to detail
Ability to clearly express and exchange ideas by means of verbal and written communication
Ability to support sales/business development and marketing through client presentations, seminars, etc
Ability to manage projects and timelines
Proficient in Oral & Written communication skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook, PowerPoint)
Travel is required 25%, Domestic/International, Daily/Overnight

148

Principal Scientist Resume Examples & Samples

Cloning and genomic manipulation of BSL2 clinical bacterial isolates
Designing, executing, and analyzing the results in the construction of recombinant organisms
Coordinating/collaborating with Assay and Product Development to advance prototype assay designs providing information and assistance to other departments to support product scale-up, manufacture and launch
Technical professional in projects, providing scientific/technical expertise with accountability for product research and development activities
Ensures technical activities are conducted within internal and external guidelines and regulations. Works with legal department to assess intellectual property when necessary
Presents findings or comprehensive project status reviews. Applies advanced technical writing skills to produce reports and documents

149

Principal Scientist Resume Examples & Samples

OTC Monograph or Regulatory experience
Acts as a liaison to evaluate external technology and develop new technical expertise internally
Identifies, evaluates and delivers new technology, materials or ingredients
Presents finding at conferences, publishes paper, authors patents Coaches and mentors peers and other staff to develop new technical skills
Communicates collaboratively and influences staff at all organisational levels with both internally and externally with specific organizations
Facilitates and manages internal and external relationships within Consumer Healthcare, GSK as a whole, and with external groups toward fostering a an environment of knowledge sharing when applicable
Champions creativity in teams to deliver innovation to the business

150

Principal Scientist Resume Examples & Samples

Development of algorithms and methods for next generation sequence analysis in Oncology
Algorithm implementation and optimization using Java
Bioinformatics tool prototyping using Python/Perl
Collaboration with experimentalists to develop analysis tools for assay optimization
Written and verbal presentation of data-driven analyses, results and methods

151

Principal Scientist Resume Examples & Samples

Collaboration with discovery teams to invent novel medicines including defining project strategy and driving execution
Championing a “design first” strategy within project teams to achieve better molecules faster
Active participation in recruitment, training and development of staff within the Modeling and Informatics group
Contributing to the global Modeling and Informatics strategy across all research sites
Continuing research in new areas of molecular modeling relevant to drug discovery and development
Maintaining an external scientific presence including authoring significant scientific publications and presentations
Minimum of (8) years experience in the Pharmaceutical Industry
Strong communication skills, along with the ability to work well in multidisciplinary teams
Evidence of creative application of computational approaches to problems of biological or chemical interest
5% Travel

152

Principal Scientist Resume Examples & Samples

Ph.D. in either Biochemistry, Chemistry or closely related discipline
At least 3 years’ experience working in skin/product interactions, particularly surfactants
Good understanding of clinical testing and protocols and the biochemistry and structure/function of the skin
Experience working with key opinion formers in the dermatological and pediatric skin area is highly desirable, as well as experience establishing and working with external/academic collaborations
At least 3 years of project management experience
Strong written & oral communication skills

153

Principal Scientist Resume Examples & Samples

Functioning independently as the Principal Investigator and technical expert, develop, perform, and troubleshoot bioanalytical laboratory experiments, tests, and procedures within accepted regulatory compliance
Function as the primary contact for the planning and execution of Sponsor interaction related to research and method development, and for the design, scheduling, conduct and reporting of studies
Ensure raw data is accurate, complete and in appropriate order to meet protocols, SOP specifications, and GLP requirements
Prepare high quality final reports appropriate for the study including method development, qualification, and sample analysis reports
Provide oversight of the laboratory and mentor scientific staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation. Provide scientific expertise in study conduct, design, and interpretation
Perform advanced troubleshooting on analytical instrumentation including chromatography and mass spectrometry systems
Direct the development and communication of departmental systems, SOPs, policies, and procedures
Attend and present at scientific meetings
Experience: Minimum of 8 years related experience in the contract research, academic, or pharmaceutical industry
Certification/Licensure: Certification as appropriate for specialty preferred
Other: Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Knowledge of applicable international guidelines for all types of studies. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and analytical instrumentation software

154

Principal Scientist Dmpk Resume Examples & Samples

Completion of lab books to department standard
Accurate analysis, reporting and presentation of scientific results
Design, plan and carry out appropriate experiments to meet DMPK (ADME) client requirements
Preparation of complex reports to a standard suitable for presentation to clients following management approval
Act as DMPK (ADME) Project Coordinator, managing client requirements, workflow, data interpretation and reporting within required timelines
Present work formally and informally to supervisors, peers and clients
Develop troubleshooting capabilities and provide advice to others in areas of own expertise for example assay types (e.g. distribution, metabolism, physchem), bioanalysis or PK/PD
Understand the relevant IT systems and learn how to use them effectively (for example, timesheets, purchasing, excel, word, Powerpoint, project databases, instrument software, Biobook and WinNonLin as appropriate)

155

Principal Scientist Resume Examples & Samples

Maintain the flow cytometry facility by calibrating and troubleshooting FACS analyzers and sorters
Constantly expand and validate cell surface and intracellular markers to identify and enumerate different types of cell population
Generate immunophenotyping data with various cells and tissues to support internal or external oncology studies
Provide technical guidance to the research staff
Demonstrate independence in data analysis and effective experimental design
Experience: 2 to 6 years related experience in the contract research or pharmaceutical industry, specifically in Immunology Research preferred. Previous managerial experience in industry is highly desirable. Prior experience in working with oncology projects with special reference to Tumor Micro environment preferred
Other: Effective written and verbal communication skills. Excellent leadership, organizational and collaborative skills are a must. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc. and with standard laboratory calculations. Strong technical background in high complexity, multi-color flow cytometry assays. Proficiency in the operation of cell sorters and FACS analyzers. Competency in FACS analysis software

156

Principal Scientist Resume Examples & Samples

Develop process and identify critical process parameter in manufacturing scale via Lab Trial, Pilot Trials to ensure quality is maintained during large-scale production
Provide input/recommendation on equipment modification to enable process changes for new product development if required
Prepare and review documents required for New Product Launch
Support maintenance and calibration of Pilot equipment e.g. Pilot vessel, laboratory equipment, DI water system, utility system, etc., ready for use, included maintenance program, and periodic checking and sampling
Lead implementation and improvement of GMP requirement
Bachelor's degree in all related chemistry science, industrial chemistry, electrical technology, mechanical technology, electrical engineering, mechanical engineering, or related disciplines
5 years of work experience in manufacturing environment, technical skill, mechanical engineering or electrical engineering
Good communication and collaboration skill
Good command of English with good proficiency in computer (Excel/Word/SAP)R&D

157

Principal Scientist Resume Examples & Samples

Primary point of contact for sponsor relationships
Ability to compile data and create data report
Critically review of data in the context of the application
Independently design, plan and perform/manage routine projects
Within minimum guidance, design, plan and perform/manage non-routine projects
Understand and use analytical instrumentation for routine and non-routine work and effectively troubleshoot related problems
Competency in the critical review of data in the context of the application
Effective troubleshooting or assay related performance issues
Mentor and train junior staff
Effectively manage a team to meet timelines
Write SOPs, policies, guidelines
Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or Ph.D. preferred
Experience:Minimum of 6 years related experience in the contract research, academic, or pharmaceutical industry

158

Principal Scientist Resume Examples & Samples

Serve as project team leader for livestock wellness and performance projects (including pain/welfare, performance and reproduction)
Serve as champion, biology lead and in-life phase clinical monitor for livestock and laboratory species
Develop new animal models/surrogate endpoints
Prepare Animal Use Protocols
Source, place and execute studies internally and externally with contract research organizations
Initiate required legal and financial documents for research activities
Contribute to development of product profiles with Commercial and Strategic colleagues
Educational background: Minimum MS (Animal Science or related area) and at least 10 years animal research experience, or PhD (or equivalent) in Animal Science or related area and 5 yrs experience; DVM (or equivalent) with experience preferred, double expertise (like DVM + PhD) a plus
Training or experience in in livestock developmental biology and/or biological sciences, veterinary medicine, livestock industry or research
At least 5 years of experience in conducting animal studies including all aspects of design, execution, interpretation and reporting
Experience in the establishment of new animal models, running clinical protocols required for projects during research and possibly development phases
Demonstrated interest in and/or publications relating to livestock welfare, growth and performance
Self-starter, able to work efficiently with minimal supervision

159

Principal Scientist Resume Examples & Samples

Independently applies scientific principles and techniques to analyze samples using a variety of chromatographic techniques, solve problems, and suggest method improvements
Develops own work priorities and plans from specific objectives
Lead projects and become the client-employee liaison to ensure quality of services, performance, and adherence to policies and procedures
The incumbent will serve as a technical resource for junior staff and others within the organization
A minimum of 7-10 years of relevant work experience after PhD is strongly preferred
Group and/or project leading experience is preferred
Experience in a CR0 or high throughput laboratory preferred
Flexibility to apply their knowledge to new areas and thrive in a team environment
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
PhD in chemistry with emphasis on analytical chemistry or equivalent experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
Advanced chromatographic experience required including GC, HPLC, GC/MS, GC/MS/MS, and LC/MS/MS
Experience performing work under Quality Management System such as ISO 17025, GMP, or GLP

160

Principal Scientist Resume Examples & Samples

A minimum of 5 years’ industry experience with a proven track record of scientific excellence and successful research
Knowledge and experience in organic synthesis
Demonstrated creativity and innovation in problem solving
Productivity and efficiency working in the lab
Excellent collaboration skills
Ability to contribute to and lead cross-functional teams and influence team strategy and decision-making
Established scientific reputation supported by publications and external presentations
Demonstrated ability to develop talent through good mentoring skills

161

Principal Scientist Resume Examples & Samples

BS in Chemistry, Chemical Engineering, Industrial Chemistry, Biomedical Science, or related discipline; and 9 or more years of related experience and/or training; or Masters with 7 or more years of experience and/or training; or PhD with 4 or more years of experience and/or training; or equivalent combination of education and experience
Experience in the medical device industry would be an additional asset
May contribute to the development of policies and procedures
May act as a mentor to less experienced colleagues

162

Principal Scientist Resume Examples & Samples

Develops new Model and Support materials for 3D printing for the investment casting market
Develops new materials/formulas and improves existing materials/formulas for investment casting
Works under the direction of department director with limited supervision. Able to solve problems, propose approaches, develop test methods, and use instrumentation
Transfers new formulations to manufacturing, including setting specifications, manufacturing processes, and test procedures
Writes technical reports and gives presentations, as needed
Demonstrates commitment to Stratasys Core Values by leading, acting and behaving in a manner consistent with these values
Follows all company safety policies and procedures and attends all safety trainings related to the job
Ph.D. in Organic Chemistry or Polymer Chemistry
At least 5 years formulation experience
Able to work independently to achieve assigned goals
Demonstrated experience writing periodic progress updates and documenting research in technical reports
Expertise in DSC analysis
Experience with silicon chemistry and/or UV curing a plus
Ability to thrive in a small company environment with limited internal resources and dynamic product development environment
Ability to cooperate and collaborate with team members with complementary technical backgrounds and skills
Ability to work successfully with outside commercial and / or academic institutions in materials formulation, testing and / or certification
Committed to high quality, attentive to details and driven to closure
Good listening, organizational and documentation skills
Experience in formulation of materials for drop-on-demand printing preferred but not required

163

Principal Scientist Resume Examples & Samples

Lead technical project teams and own individual high-level projects focused on key analytic deliverables and analytic innovation projects working effectively with cross functional teams (i.e. Pre-sales, Product Management, Development) meeting project road maps and delivery timelines
Coach scientists through project work assignments and assist in developing career opportunities for them
Perform hands-on analysis and understanding of large amounts of historical data to determine the most suitable modeling techniques while showcasing expertise with different types of algorithms and modeling processes with cutting-edge analytic techniques
Work directly with clients and support models in production, expected to travel up to 30%
Develop intellectual property and create patents
MS or a PhD degree in a statistics, physics, engineering, mathematics, computer science or other related analytic field
Significant senior level experience in predictive modeling coupled with software development experience in C, C++ or Java
Significant experience with employing neural networks, machine learning, mathematical/statistical modeling, pattern recognition, or data mining on real world problems
Large dataset analysis: Experience with analysis of large datasets. Strong skills in scripting languages such as Python, Perl or Bash; knowledge of data-cleaning techniques and their uses on large datasets. Experience in performing statistical analyses leading to the understanding of the structure of the data

164

Principal Scientist Resume Examples & Samples

Protein engineering and in silico modeling
Synthetic biology
Directed evolution
Must be able to prepare reports and present data
U.S. Citizenship is a MUST to comply with government contract
3+ years post graduate experience. preferably in an industrial setting

165

Principal Scientist Resume Examples & Samples

Liaise in pro-active and engaged manner with Therapeutic Area Scientists and devise solutions to their scientific questions using cutting-edge computational biology approaches
Ensure prioritization, triaging and tracking of computational biology projects and tasks in support of new therapeutic concept and biomarker research within a TA
Proactive role, engaging in strategy at TA level and indication level, proposing computational biology approaches, projects, external collaborations that can enhance and have a concrete impact on the TA strategy in the form of new therapeutic concepts and biomarkers
Act as an ambassador also for other technologies in Target Discovery Research (TDR) (e. g. from the target validation technologies group), promoting all TDR technologies and identifying/proposing questions that could be addressed through integrated use of TDR technologies within and beyond computational biology
Backtranslating core target product profiles into concrete new therapeutic concept plans
Definition of biomedical data to be acquired and/or generated in order to support TA
Develop strong relationship with Head of Expert Team, ensuring a smooth interaction, definition of workpackages within expert team, and adequate exchange of tasks between partner and expert teams in the interest of overall scientific impact on TA research
Supporting head of partner and Head of Expert function to ensure that overall computational biology strategy is at the cutting edge of innovation in the field, while ensuring concrete impact, by piloting novel approaches in well defined scientific areas of need
Coordination of priorities and work with key computational biology staff at other research sites, in particular for TA which have a global footprint

166

Principal Scientist Resume Examples & Samples

Accountability for formulations & process deliverables in assigned projects aligned with the control strategy and overall project plan
Lead and support development of parenteral, topical and ophthalmic projects formulations
Support entire drug product development process starting with first pre-formulation studies up to the manufacturing process transfer to production and the provision of the required documentation to allow worldwide registration
Lead/support development of robust formulations and processes through optimization, scale-up and validation work applying QbD principles incl. risk assessments and DoEs
Evaluate the data and provide the input for the selection of next experiment
Ensure high quality preparation & support on documentation to allow timely start of GMP batches
Seamless coordination and communication with cross functional team to achieve the project goal
The candidate should have hands on experience of liquid parenteral, Emulgels, Emulsions, suspension and freeze dried products)
Working in international project teams

167

Principal Scientist Resume Examples & Samples

PhD in neuroscience, physics or a related discipline with 4 years of experience studying coding and computation in high-throughput recordings of neural activity from behaving animals using quantitative methods, such as dimensionality reduction, time series analysis, and machine learning approaches
Demonstrated experience in at least 3 of the following disciplines: high-throughput electrophysiology, multi-photon microscopy, optogenetics, circuit mapping, methods for manipulating cognitive processes in behaving animals
Training and demonstrated capabilities in applied mathematics and computer science. Must be proficient with at least one numerical analysis and statistics framework (e.g. NumPy, Matlab, R) and one general-purpose programming language (e.g. Python, Java, C)
Two years of experience coordinating collaborative projects with diverse technical contributors and aggressive timelines for achieving results, as evidenced by research publications, public data sets or other artifacts of work
Clearable to TS or TS/SCI
Strong background in systems neuroscience, with at least 2 years of experience studying the circuit basis of cognition
Strong background in machine learning (ML), with at least 2 years of experience using modern ML techniques to support scientific research or solve other challenging problems
Active Clearance
Formal training in theoretical neuroscience
Professional software development experience
Experience using cloud computing technologies
At least two (2) years of experience with the IC or other Government-run analysis and evaluation

168

Principal Scientist Resume Examples & Samples

Enhance our understanding of SAR and influence team strategy by assimilating and interpreting data using modeling and data-mining technologies
Apply and develop new approaches for designing bioactive-relevant features using machine-learning, scoring functions, and multiple endpoint optimization methods
Maintain and develop working knowledge of contemporary computational chemistry methods and their use in ligand design and data analysis as applied to drug design projects
A completed Ph.D. in physical organic chemistry or a related field with strong theoretical background as demonstrated by contributions to leading journals
A minimum of 6-10 years of relevant Computational Chemistry / Chemical Informatics experience is preferred
It is highly desirable that you have familiarity with machine learning techniques, multiple parameter optimization methods, quantum chemistry, docking methods, molecular dynamics, and homology modeling approaches
Ability to serve as a lead computational chemist on multiple drug discovery projects

169

Principal Scientist Resume Examples & Samples

Develop stability protocols and execute stability studies for key reagents and buffers
Establish shelf life and make storage recommendations for all key reagents and buffers
Participates in the expeditious transfer of products and technologies by providing scientific knowledge and assistance
Take a new perspective on existing solutions, exploring and implementing new concept and methodologies
Assist in the development of test methods for process improvements
Design experiments to establish correlation between reagent specifications with functional sequencing performance on instrument
Report on process stability

170

Principal Scientist Resume Examples & Samples

Leads, inspires and motivates a creative team of Biophysics personnel in routine day-to-day operations
Demonstrated expertise in NMR, SPR, MS, ITC, Tm and other biophysical techniques. Demonstrated expertise in applying these techniques to antibody, fragment and small molecule research
Implements the best biophysical practices and innovations, assists in the assessment of technologies, and methodologies for in-licensing and integration to enhance biophysically efficiencies and quality
Collaborates with scientists from other research functions to ensure timely progress in research projects and presents project updates to management
Implements exploratory research to support identification and characterization of antibodies, small molecules or fragments; conducts extended studies to investigate the mechanism of action as related to the binding of mAb to target antigen or small molecule fragments to protein targets
Maintains a current understanding of the analytical literature, as well as the scientific literature related to specific drug discovery projects
Prepares and organizes data for presentation. Presents written and oral reports to management. Communicates research efforts to collaborators, corporate partners, or at scientific meetings
Coordinates and manages resources within the Biophysics Group for drug discovery projects in order to ensure timely achievement of goals
Makes a significant impact within project teams to advance programs from early phases to developmental phases
Recognized as an internal expert in the area of biophysical characterization of monoclonal antibodies and the screening of fragments
Publishes original research and review articles in scholarly journals in order to build the reputation of Takeda California and the Biophysics Group
Serves as an intra-company consultant for all biophysical issues that may arise during the drug development process
Provides supervision and support to new endeavors as assigned
Ph.D. in Physical Science with thesis, publication(s), postdoctoral experience, and a minimum of 8 years relevant scientific and technical experience including industry experience OR MS with 18+ years of experience OR 20+ years of relevant experience
Knowledgeable in all biophysical and analytical aspects of drug discovery from target discovery through early clinical development
Track record of efficiency and productivity of non-clinical analytical and biophysical characterization in drug development programs, including antibodies and fragments, from leads to clinical candidates
Demonstrated ability to work in a dynamic start-up environment and matrix organization
An expert in biophysical and analytical biochemistry issues related to drug discovery and its applications to protein drugs, specifically therapeutic monoclonal antibodies and small molecules or fragments
Highly motivated and flexible with ability to work in fast-paced environment. Ability to provide novel creative solutions to challenging problems. Desire to learn and tackle new challenges and initiatives
Proven track record of scientific contributions in life science as evidenced by quality and quantity of publications/presentations/inventions and/or products and clinical candidates
Novel problem solver for any obstacles that may be encountered in the molecular or chemical characterization of therapeutic monoclonal antibodies or small molecule fragment screening

171

Principal Scientist Resume Examples & Samples

Analysis of various –omic-scale data including RNA-Seq, Exome and Whole Genome Sequencing, single cell sequencing, and high throughput proteomics in order to nominate novel drug targets, enable patient enrichment strategies, understand mechanisms of resistance to IO therapies and prioritize combination therapies
Integration and mining of large scale external data sets (TCGA, 1KG, EXAC, Cosmic) to further our understanding of the relationship between tumor genetics, the tumor microenvironment, and response to therapies
Evaluate and analyze exploratory genomics data from clinical trials to understand drug mechanisms and patient response
Perform integrated- and meta-analyses of –omic data across multiple clinical trials
Extract insights and generate hypotheses to be evaluated in future trials and to inform our discovery pipeline
Collaborate with bioinformaticians, statisticians, biologists, and clinicians to identify critical questions that can be addressed via computational approaches
Design, lead, and manage complex computational research projects
Help define our bioinformatics strategy to advance BMS’ Oncology/Immuno-Oncology pipeline
Ph.D. in bioinformatics, engineering, statistics, physics, molecular biology, genetics, or a similar discipline
Ten (10) or more year’s relevant experience in tumor biology, tumor immunology and/or drug discovery in an academic, pharma or biotech setting
Proven track record designing, leading, and managing complex computational research projects
Experience working in complex, matrixed organizations expected; experience leading projects in a matrixed environment preferred
Strong background in -omic (DNA, RNA, epigenetic, proteomic) data analysis and biological interpretation
Experience working with data from clinical trials is expected
Solid background in Oncology and Immuno-Oncology biology
Ability to communicate effectively with biologists, biostatisticians computational and clinical scientists
Proficiency using R and Bioconductor packages, at least one scripting language (Python, Perl), and SQL
Experience working with Linux high performance compute clusters and cloud based computing platforms (Amazon EC2)
Fluency in NGS experiments and data analysis (e.g. GATK, Cufflinks, SAMtools, BAMtools etc.) is expected
Working knowledge of commercial and publicly available biological databases including NCBI, Ensembl, ArrayExpress/GEO, SRA, TCGA, 1000 Genomes etc.)
Strong verbal and written communication skills, with the ability to analyze and present data in a clear professional format to computational, bench, and clinical scientists

172

Principal Scientist Resume Examples & Samples

PhD in biochemistry, biophysics, cell biology, pharmacology or related areas is required
At least 8 years of industry experience in assay development HTS is required
Expertise with biochemical methods such as FP, HTRF, luminescence and SPA OR an expertise with biophysical methods such as SPR, thermophoresis, ITC and mass spectrometry is preferred
Fragment screening experience is preferred
Previous people management experience (supervising, coaching, mentoring) is required

173

Principal Scientist Resume Examples & Samples

Collaborate as full team member (R&D Microbiology Dept. subject matter expert) on Beverage Product and Process development teams
Design and execute microbiological risk analysis & risk management studies for product, process and package development initiatives, and provide microbial risk assessment insights using effective communications skills
Develop, assign, and approve microbiological specifications for beverage ingredients as required using current PepsiCo software systems
Investigate and help implement new/improved microbiology methods and techniques within R&D and manufacturing facilities
Mentor and provide a strong professional role model for other individuals in the Microbiology Dept. Experience in people management a plus, but not required
On request, investigate key manufacturing plant-related issues and help develop long term solutions
Help provide training for R&D and Manufacturing personnel in the areas of Food Microbiology, Food Safety, and Lab Quality Assurance
Working knowledge of manufacturing food safety and quality assurance principles and programs. Knowledge of FDA and USDA regulatory requirements and GFSI standards. Experience in facility program management or auditing a plus, but not required
B.S. in Microbiology or Food Microbiology from an accredited institution with a minimum of 8 years of beverage/food industry experience or M.S. / Ph.D. in Microbiology or Food Microbiology with a minimum of 6 years of beverage/food industry experience
Strong foundational knowledge of beverage/food microbiology (spoilage organisms, pathogens, and indicator microorganisms). Experience working with commercially distributed high-acid and/or low-acid beverages is strongly desired
Solid hands-on laboratory microbiology skills (bacteria, including major foodborne pathogens and sporeformers, mold and yeast) and willingness to carry out research oriented lab work as required
Experience with design of microbiological challenge and shelf-life studies
Fundamental understanding of FSMA, thermal processing, HACCP, food safety and sanitation principles
Ability to utilize in-depth knowledge, problem-solving skills and an awareness of PepsiCo priorities to achieve stated results and to provide microbiological insights and problem resolution paths
Must demonstrate initiative, commitment, resourcefulness and a passion for supporting Innovation and improving the Quality of PepsiCo's brands
Proven research project design, application and project management skills
Strong data interpretation skills - i.e., Demonstrated ability to distill data and/or test results into business-focused technical recommendations
Functional computer software skills (Microsoft® Word, Excel, PowerPoint, Outlook)
Travel within U.S. is required (estimated at 10%). International travel on occasional basis

174

Principal Scientist Resume Examples & Samples

1) Ph.D. in biology with >8+ years of working experience after receiving Ph.D. (prior industrial drug discovery experience within therapeutic mAb field preffered)
2) Excellent track record of scientific publication and/or drug discovery expertise
3) A broad and integrated knowledge of biologics
4) Research and/or drug discovery experience and expertise in antibody generation
5) Demonstrated capability to work in matrix teams, lead and manage scientists
6) Effective communication skills
3) Effectively resolve scientific and technical challenges related to antibody generation
4) Using scientific knowledge and subject matter expertise/experience to enable program progression
5) Positively influence program/project direction and progress using expertise and experience
6) Supervise/manage/support biologics team scientists to achieve their objectives
7) Accept ownership and strive to enhance team’s performance through effective and efficient management of resources
8) Document scientific findings according to business practices (for both internal and external studies)

175

Principal Scientist Resume Examples & Samples

Act as key tech lead for lyophilization process development. Design and manage studies for protein lyophilization cycle development, cycle optimization, lyo process scale-up, and technology transfer
In-depth knowledge in determination of heat transfer coefficient, cake resistance, and lyo process modeling
Design and oversee studies for protein formulation development, optimization, and robustness
Broad experience in protein characterizations, both in liquid and lyophilized forms, using different analytic techniques, including DSC, HPLC, SDS-PAGE, Karl Fischer, XRD, CD etc
Investigate and elucidate the mechanism in protein instability during the handling and manufacturing process
Closely interact with other formulation, device, and process development teams for formulation/process transfer and optimization
Draft transfer protocols and manage the formulation tech transfer process to manufacturing or CMO sites
Provide technical support for global formulation and fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization
Write and review study protocols and tech transfer documents, present study data both internally and externally
Good understanding of regulatory policies and guidelines governing formulation and product development process

176

Principal Scientist Resume Examples & Samples

Develop numerical and string algorithms for RSS bioinformatics solutions in infectious disease applications
Collaborate with molecular biologists to build solutions for infectious disease applications
Collaborate with other software engineers and bioinformatics scientists to deliver best-in-class bioinformatics solutions and analytics
Utilize best practices in software engineering: design & planning, testing, code reviews, collaborative version control, continuous integration, etc

177

Principal Scientist Resume Examples & Samples

Develop and modify bioinformatics methods to analyze cell free DNA using innovative molecular and computational technologies
Apply advanced statistical methods to determine and mitigate sources of bias and noise in complex datasets
Validate and test microarray-processing algorithms for effects on interpretation of diagnostic results
Document methods and studies to enable the deployment of IVD tests in a regulated environment

178

Principal Scientist Resume Examples & Samples

Plans and directs interdisciplinary environmental projects of large scope and complexity
Serves as a technical leader and as a recognized expert in field of practice
Provides regulatory compliance consulting services as an authority in field of specialty
Prepares proposals and cost estimates
Maintains affiliation with professional societies to keep abreast of current technologies
Prepares and presents technical papers and reports. May review and assist in completing technical reports and documents prepared by others
4-year degree in a science curriculum related to the assigned discipline
10-15 years of related work experience including experience as a task leader
Proficiency in various computer software applications typically used within the assigned discipline is required
Requires a demonstrated proficiency in both written and oral communication skills
Thorough understanding of all environmental rules and regulations

179

Principal Scientist Resume Examples & Samples

Taking responsibility for the transfer of the EIMEA R&D microbiology capability and laboratories to a new technical centre in Reading
Leading CISPRO5 implementation, a new digital system for maintenance and service control of lab equipment
Standardising development of ELN templates from a compliance point of view as MCO technical leader
Translating R&D technologies into plant applications (a key development area at our Innovation Centres at Egham and Reading)
Minimal requirement a Masters in Microbiology or similar
Ideally a PhD in Biotechnology or similar

180

Principal Scientist Resume Examples & Samples

Function independently as a study director in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research
Participate in and coordinate all phases of the study planning process with appropriate departments
Review, interpret, integrate, and present data on assigned studies with minimal assistance
Function independently as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting
Assist in the oversight of the laboratory and mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and technique validation
Review reports for peers as needed
Provide technical and scientific guidance to the research staff
May supervise research and/or scientific staff, as appropriate for scope of responsibilities
Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Demonstrate leadership skills as they pertain to intra- and interdepartmental initiatives, Sponsor interactions, and business development. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, Powerpoint, etc. and with standard laboratory calculations. Proficiency with NCA using Phoenix WinNonlin software

181

Principal Scientist, Sequencing Resume Examples & Samples

Manages NIPT projects with or without subordinates
Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects
Provides input to budget and helps to allocate expenditures efficiently for activities individual manages. Forecasts resource needs. Identifies opportunities to reduce costs
People management responsibility have full HR responsibility for direct reports and/or indirect reports
Sets goals that have short-term (0-3) years positive impact on team members and the organization

182

Principal Scientist Resume Examples & Samples

Identifies significant areas of scientific inquiry that may be related to medical device therapy, designs research projects to investigate such areas, and carries out or directs such projects to completion
Performs or directs the performance of preclinical studies, including GLP studies for submission to regulatory agencies
Publishes research findings in scientific press and may otherwise disseminate findings at conferences and symposia
Remains aware of patent implications of research; takes appropriate steps to review patent implications with attorneys and with management; prepares documentation for patent applications whenever required to protect value to the company
With approvals, may collaborate with and/or direct research projects carried out at universities and laboratories outside of the company
Assesses own and others’ research results in order to develop recommendations for future research directions and projects
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Bachelor’s degree in relevant engineering or scientific discipline and 12+ years of progressively responsible experience in a medical device company
Demonstrated track record of innovative scientific accomplishments, approved patents and breakthrough technical contributions
Outstanding technical leadership skills
10+ years of experience executing preclinical studies, including GLP studies
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Masters or PhD in relevant engineering or scientific discipline preferred
Experience working in a broader enterprise/cross-division business unit model preferred

183

Principal Scientist Resume Examples & Samples

Collaborate with software engineers and bioinformatics scientists to architect and develop scalable bioinformatics pipeline solutions for infectious disease applications
Collaborate with software engineers and bioinformatics scientists to set software engineering best practices, including usage of github, Jira, Jenkins, workflow languages, etc
Prototype graphical user interfaces for NGS applications
NGS relational database support and management

184

Principal Scientist Resume Examples & Samples

Accountable for the performance and results of multiple project teams responsible for the late stage development and commercialization of sterile drug products
Applies expertise in sterile drug product across projects to optimize efficiency, and to create and leverage best practices
Ensures project results meet requirements related to science, quality, reliability, schedule, and cost. Reallocates people and budget within and between projects on an ongoing basis, so as to optimize business results
Recognized as a technical expert and significant scientific contributor. Has a mastery of scientific/technical concepts and techniques, applies and furthers those concepts and techniques in pursuit of resolving scientific/technical issues
Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline
Uses advanced experience gained on scientific/technical issues to guide others to address nonroutine and/or difficult issues
Serves as a resource for scientific knowledge and technical training to expand the scientific knowledge base and technical capabilities of others
Serve on crossfunctional teams and support strategic initiatives
Supports due diligence and business development opportunities
Potentially manages a small group of individual contributors (professional and contract employees)
Provides technical oversight and strategic guidance to employees. Coaches employees on long term career development/leadership capabilities
Sustains a culture that promotes employee development through developmental assignments and training
Creates opportunities for others and delegates responsibility to the lowest appropriate level
Travel to research and manufacturing sites as required

185

Principal Scientist Resume Examples & Samples

Data modeling, analytics and visualization
Data mining and machine learning
Algorithm design, implementation
Physiological signal processing
Knowledge of human physiology
Knowledge of healthcare industry
Trends in patient care at hospital and home
Assessment of drug effectiveness and adverse drug events
Publishing scientific papers and presenting at scientific conferences
Government grant applications
High performance computing using Hadoop, cloud infrastructure, or related technology
Database technologies
Ability to work with cross-functional teams

186

Principal Scientist, Package Development Resume Examples & Samples

Actively participate in teams, projects, networks and/or platforms. Actively contribute to team goals. Fulfill related tasks and responsibilities related to own discipline and ensure all own activities are aligned with overall drug development process. Provide strategic and scientific contribution to Networks, with target achievements according to network charter and objectives. Interpret results, evaluate data, draw relevant conclusions, and write reports. Contribute to risk analyses and/or peer review and process challenge meetings. Interact/collaborate with Research and/or other functions in Development to facilitate transfer of knowledge and deliveries primary packaging or medical devices
Proactively support generation of international registration documents, including interaction with authorities where appropriate. Generate appropriate scientific documents to hand over to internal and/or external agencies or partners
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s). Proactively contribute to setting, updating and monitoring of team goals
Translate team goals into daily work. Coach team members and support objectives setting, performance evaluations and development planning discussions where appropriate. Support the journey towards a multi-skilled, highly innovative and motivated workforce operating in a self-directed team set-up. Engage and drive culture change consistent with GDD values and objectives. Consistently demonstrate good change management practices to protect product quality
Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms. Work according to appropriate SOPs, GMP, GLP, DQP, QM, HSE, ISEC & Novartis Guidelines. Provide quality documentation and assessments in a timely manner
Actively participate in budget forecast, grant preparation and tracking of invoices. Demonstrate cost awareness in all assigned projects and/or networks. Contribute to evaluation of new scientific technologies/equipment and prepare CAR and USR if applicable
5+ years of packaging experience in the Pharmaceutical or Medical Device industry developing solutions and leading packaging and/or device programs
Thorough understanding of development processes in primary packaging and medical device development
Strong leadership skills
Strong knowledge of relevant SOP, GLP, GMP and Novartis regulations and policies
Very good communication skills. Good presentation skills and scientific/technical writing skills. Advanced coaching skills
Profound literature search skills
May require up to 15% travel

187

Principal Scientist Resume Examples & Samples

Provide scientific guidance and technical expertise for biological assessment of modified mRNA on cross functional platform teams
Develop, implement and execute cellular models to inform on the molecular mechanism of chemical and structural modifications on mRNA trafficking, protein translation, protein interactions, innate immune activation and other homeostatic cellular processes in mammalian cells and tissues
Independently design and execute studies to understand proteins and cell signaling pathways associated with mRNA delivery
Evaluate and incorporate whenever possible cutting-edge technologies and models to drive creative molecular/cellular research
Accountable for project strategy, execution, communication of results and follow-up
Collaborate broadly with members of the program teams and departments throughout Moderna
Establish and foster external collaborations to access additional resources
Prepare and present findings at department and project team meetings
Ph.D. in Cell Biology, Molecular Biology or In Vitro Pharmacology, with at least 10 years of industry and/or academic experience investigating mechanism of modulation of cellular pathways preferably working with nucleic acids
Hands on experience with diverse cell culture models, molecular and cellular techniques, mammalian primary cell culture, and their use in dissecting nucleic acid/protein function
Demonstrated understanding of molecular biology, cell biology and biochemistry
Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment
Familiarity with nucleic acid therapeutics and nucleic acid delivery
Ability to multi-task to meet aggressive technology development and research goals

188

Principal Scientist Resume Examples & Samples

Provide scientific guidance and technical expertise for biological assessment of lipid formulations on cross functional platform teams
Develop, implement and perform of cellular models to inform on the molecular mechanism of entry and cytosolic release of novel mRNA formulations in cells and animal tissues
Ph.D. in Cell Biology or Virology, with at least 8 years of combined postdoc/industry experience in membrane biology
Hands on experience with diverse cell culture and tissue models
Demonstrated understanding of lipid delivery and trafficking mechanisms

189

Principal Scientist Resume Examples & Samples

Team Leader for several projects of medium-to-high complexity, many having significant revenue potential
Actively invents, develops and disseminates new technologies/solutions in support of projects and customers
Proactively leads activities that provide general support to the department, company, or technology
Skillful knowledge of multiple product lines and technologies
May lead in activities to eliminate waste and refine work processes or other labor saving methods. i.e. lean manufacturing
Communicates results and project strategies effectively through both oral and formal written reports to appropriate personnel as requested
He/she is expected to provide strategic technical leadership by identifying new areas of technical and business opportunity for the corporation based on his/her technical and/or industry knowledge
The incumbent is familiar with the Quality Policy and business practices of the company. He/she participates in the company program to maintain ISO/TS certification
Ability to travel both globally and domestically up to 25%

190

Principal Scientist Resume Examples & Samples

Ph.D. or equivalent in Biomedical Informatics, Computer Science, EE or related quantitative fields
Expert expertise/knowledge in the one or more of following areas: Computational Biology, Bioinformatics, Biostatistics, Genetics, Infectious Disease, Infection Control, Cancer Genomics
10+ years of research experience in the design, development, and evaluation of personalized medicine related technologies for infectious disease and oncology
5+ years’ experience in efficient pipeline/workflow development and data visualization for large NGS data analysis (using programming languages like Python, Java, C/C++ and R or equivalents)
5+ years of work experience in the design, development, and evaluation of clinical decision support applications and systems for healthcare industries. Track record of bringing new technologies to new product introduction with commercial success
Solid knowledge on clinical workflows and information systems on infectious disease and or oncology
Effective in a large matrix organization to achieve strategic objectives and deliver impactful innovation to business
Successful leader with track of record in leading multiple remote multidisciplinary teams
Excellent verbal and written communication skills with different stakeholders (including clinicians, business R&D managers, marketing managers)
First author publications in informatics journals/conferences
Phylogenetic analysis/Population genetics
Metagenomic analysis and microbiome research
Alignment, assembly, analysis of microbial genome sequencing data
Software prototyping experience in a clinically oriented research environment
New business development experience

191

Principal Scientist Resume Examples & Samples

Supports all TT related activities from development to launch for new Drug Products (DP) from and to all BMS and CMO manufacturing sites using principles defined in our internal directives and ICH, FDA and other regulatory guidelines
Collaborates with API teams (PD, TTT, etc) to ensure delivery of appropriate and robust DP manufacturing process
Performs risk assessments to evaluate the probability and impact of risks, establishes mitigation strategies and provides input and maintains the product risk register and related risk mitigation activities
Evaluates and sets requirements for process analytical technology (PAT) that enables the DP control strategy
Ensures QbD principles are followed during development and tech transfer, key and critical process parameters are identified and appropriate monitoring programs and controls are in place
As needed, leads significant technical investigations and/or support manufacturing sites and Quality organization in technical investigations and /or troubleshooting of product/ processes issues and manage process change controls
In collaboration with MS&T-EXM, ensures that effective systems are in place at the manufacturing sites to comply with corporate guidelines for Technology Transfer, Validations, Raw Material Qualification and other TT related activities
On request participates in teams, programs or other company initiatives
Bachelor Degree in Industrial Pharmacy or Engineering (Chemical, Electrical or Mechanical) with Eight (8) years of direct related experience in Technical Services function within the pharmaceutical Industry including strong proven work experience in API and process development and technology transfers

192

Principal Scientist Resume Examples & Samples

Direct a team of Scientists and Associates tasked with identifying, and prosecuting new drug targets
Lead cross-functional teams that develop innovative strategies for developing new and effective therapeutics
Continuously evaluate a variety of in-licensing opportunities and establish external collaborations
Write preclinical study reports and contribute to regulatory filings
Present strategies and results to CMD and Discovery Research Senior staff
Establish efforts aimed at the discovery of new therapeutic targets
Doctorate degree and 8+ years of post-doctorate experience in academia or the biopharmaceutical industry
Deep content expertise in the cellular biology and physiology of cardiovascular, metabolic or renal disease and extensive knowledge of the CardioMetabolic drug discovery/development space
Understanding of and expertise in the use of human genetics to identify drug targets
Strong working knowledge of drug discovery and the development of therapeutic candidates
Experience in the development and implementation of strategies and platforms for the identification of new drug targets
Established scientific reputation in the field of CardioMetabolic diseases as evidenced by publication track record
Experience working in a cross-functional, matrixed, and global Research and Translational organization
Demonstrated ability to recruit, lead and motivate a team of scientists, and to be actively engaged in their career development
Outstanding leadership, interpersonal and communication skills
Ability to travel to Iceland for extended periods of time (3-6 months)

193

Principal Scientist Resume Examples & Samples

Managing and developing staff
Clinical biomarker assay development and validation
Assay development and qualification, up to and including knowledge of technical and regulatory requirements for diagnostic development
PhD in pharmaceutical, chemical, or biological science
5 years’ experience in a clinical biomarker lab troubleshooting multiple assay formats
Demonstrated ability to establish and execute external collaborations with both academic laboratories and CROs
Extensive critical analyses experience in both troubleshooting and implementing clinical-grade assays across the full ‘fit-for-purpose’ spectrum
Excellent organizational skills with experience in prioritizing a large number of laboratory activities
In depth knowledge across multiple technology platforms, as might be exemplified by
Familiarity with genomic technologies such as, but not limited to, next generation sequencing and transcriptional profiling in clinical samples
Previous experience with HS protein analyte methodologies/ novel ELISA development and incorporation in to clinical setting
Cytometric approaches to cell/analyte clinical measurements
Strong demonstrated ability to work in team structure; candidate will work in a highly matrixed environment and drive scientific and technical innovation collaboratively with other members of the group, as well as with Amgen research community
Proven ability to drive results and manage multiple complex activities

194

Principal Scientist Resume Examples & Samples

Lead and manage a diverse group of scientists (~3 PhD and ~4 MSc) focused on the application of advanced cellular and molecular biology approaches in the area of a) developing human-centric assays that can predict the safety profile of drugs in development, b) providing investigative toxicology support by determining the underlying mechanisms of toxicity of development candidates and providing viable paths forward to project teams, c) elucidating target biology to determine the safety profile of blocking or activating a particular pathway with a therapeutic and d) gaining insights from human genetics into the role of sequence variation in drug safety and translating findings into opportunities for predictive safety assay development
Drive strategy for the application of cell based models to support human-centric drug safety assessment both in the immediate term as well as focusing longer-term efforts (e.g. in the areas of tissue engineering and three-dimensional cell culture systems)
Drive the establishment of research alliances and collaborations through the active surveillance and exploration of external opportunities that will enable the team’s strategy and vision
Interface directly with project teams and senior leaders to ensure prioritization of efforts along with pragmatic and timely integration of data to successful support key milestones and regulatory/IP filings
Represent the group internally and externally through presentations, publications, networks, collaborations and conferences to promote and raise the profile of our work
Tightly integrate teams efforts with other principal area of focus within the group, namely, human genetics and functional genomics, computational biology and biochemistry and structural biology, to ensure a coordinated response to projects
PhD in molecular biology, cellular biology or related discipline with 7+ years of experience in the biotechnology and/or pharmaceutical industry with a particular focus on molecular, cellular and investigative toxicology
Detailed knowledge and experience of drug safety assessment in the pharmaceutical industry
Comfort and good working knowledge of human genetic association studies and computational biology
Managerial and mentoring experience desired
Excellent leadership and communication skills and the ability to influence inspire and lead teams into new scientific areas

195

Principal Scientist Resume Examples & Samples

Serve as a subject matter expert on the pharmacokinetics of small molecule therapeutics, communicate ideas and advances in the ADME sciences, and collaborate with scientists cross-functionally and across our three-site PKDM scientific community (Cambridge, MA, San Francisco and Thousand Oaks, CA)
Work with disease, biology and modelling experts to design appropriate pharmacodynamic (PD) studies to evaluate biology, PD and/or efficacy models, and to establish PKPD relationships to best meet therapeutic objectives
Devise, articulate, and implement strategies for improvement of absorption, distribution, clearance and PK/PD properties for candidate molecules
Plan, design, and coordinate or conduct PK/distribution studies; analyze, interpret, integrate and communicate study results

196

Principal Scientist, Dmpk Resume Examples & Samples

Work closely with program leaders, Research & Development, Toxicology, Regulatory, and Clinical groups to develop an overall ADME/DMPK development plan that supports the appropriate selection and efficient transition of candidate molecules from lead optimization/identification into Phase I clinical trials
Be responsible for ADME & DMPK studies for all products under nonclinical development. This includes direct interface with the contract research organizations (CROs) to provide input during protocol development phase, the derivation of cost estimates, timelines, study protocols and reports, as well as the monitoring of study activities
Support ongoing toxicology activities across Akebia portfolio (investigative efforts, impurity assessments, CRO selection, protocol development, study monitoring and data interpretation); expanding and deepening Akebia capabilities within the nonclinical space
PhD in Pharmacology, Pharmacokinetics, Toxicology or closely related discipline
At least 5 years of DMPK experience in the Biotech-Pharma industry with 3+ years of experience working in small molecule drug development
A record of developing submissions for INDs, IBs, NDAs/MAAs, and experience interfacing directly with regulatory teams and agencies
Experience using Phoenix WinNonlin and related expert analysis packages to model non-clinical PK & PD parameters
Strong communication, organizational and interpersonal skills with an ability to effectively function within a matrixed environment
Familiarity of FDA and EMA, and ICH guidance documents including GLP regulations
Experience with non-absorbable oral drugs a plus

197

Principal Scientist Resume Examples & Samples

Proven track record of metabolite identification and structure elucidation
Experience with regulatory filings and understanding of regulatory requirements
Good people management skills, excellent communication skills (both oral and written), detail oriented, and demonstrated experience in leading/mentoring a mid-sized team of junior biotransformation scientists

198

Principal Scientist Resume Examples & Samples

Lead projects of high complexity as a project team leader, driving them from conception to development candidates
Establish in vitro cell-based models of neuron-glia interactions including: myelinating cultures of mixed cortical neuron-glia, cerebellar and cortical tissue explants
Establish in vitro cell –based models of neuronal cell death in response to insults, including oxidative, excitotoxic and ionic imbalances
Conduct in vivo experimental work in animal models of MS, e.g. demyelination/remyelination and immune-driven models
Conduct laboratory research on projects for the team and the Neuroscience Research Therapeutic Area
Contribute to strategic and tactical selection and execution of targets for MS
Interact with cross functional groups and other MS team members in France and US research facilities
Efficiently collaborate with scientific staff within various groups including Chemistry, DMPK, Translational Sciences, Immunology and Inflammation in the US and EU
Establish and maintain a scientific network external to the company for access to cutting edge technology and information to facilitate internal programs
Ph.D. in Neuroscience or related field, with postdoctoral training. At least 3-5 years of research experience in MS and/or neurodegenerative diseases in biopharma strongly preferred
Strong track record of publications in neuroscience, neuroimmunology, neurodegeneration and/or MS
Understanding of neuronal and glial cell biology and pathology of MS and relevant animal models
Experience in establishing and using neuronal models in vitro for drug discovery
Ability to isolate subsets of neurons and establish primary cultures, including co-cultures and myelinating cultures
Experience with in vitro electrophysiology of cultured neurons strongly preferred
Experience in in vitro pharmacology, including dose response, PK/PD, kinetics, mechanism of action and preclinical proof of concept studies
Experience in appropriate biochemical assays
Knowledge of neuroanatomy
Excellent speaking, reading and writing skills
Strong analytical and organizational skills

199

Principal Scientist Resume Examples & Samples

Plans and/or performs studies in various in vivo models to evaluate therapeutic agents for cardiovascular and metabolic diseases
Plays a significant role in defining strategy and in vivo pharmacology processes for discovering and developing novel therapeutic agents
Leads the design and implementation of multiple complex research plans as part of the overall discovery strategy
Responsible for validity, reproducibility interpretation and statistical analysis of preclinical study data. Analyzes highly complex issues and significantly improves, changes or adapts existing methods and techniques
Develops research solutions that require extensive synthesized analysis, detailed investigation, and uncovers new approaches
Frequently interacts with senior internal and external colleagues often requiring coordination across multiple functions and groups
Interprets and integrates data to make recommendations for critical discovery/technology project decisions
Works under limited supervision with a high level of autonomy
Directs teams and sets project objectives for individual team members
May supervise/manage Ph.D. and non-Ph.D. scientists
Demonstrates excellent oral, written and interpersonal skills and is a strong collaborator
Ph.D. degree in the life sciences with a post-doctoral fellowship in liver or kidney biology, or in fibrosis-related signaling with at least 2 years post fellowship OR a Ph.D. degree in the life sciences with at least 5 years relevant experience OR a MS degree in the life sciences with at least 10 years relevant experience is required
Academic faculty or industry experience is preferred
Demonstrated understanding and experience in performing pharmacological and mechanistic studies in in vivo models of metabolic disorders is required
Expertise in liver and/or kidney physiology and mechanisms leading to metabolic disease is required
Understanding of the overall process of drug discovery and development is preferred
Peer reviewed publication record in relevant fields
Working knowledge of pharmacology principles is required
Demonstrated understanding and established level of expertise evaluating preclinical models of metabolic disease is required
A background in in vivo models in metabolic and/or cardiovascular disease models is required
Experience is Chronic Kidney Disease, NASH and/or Fibrosis is preferred6692170330

200

Principal Scientist Resume Examples & Samples

PhD in relevant scientific discipline (biology, immunology, biochemistry, chemistry, cell biology etc.) with 5+ years of relevant industry experience
Familiarity with GLP regulations, Bioanalytical Guidance (FDA, EMA), and Immunogenicity Guidance (FDA, EMA) is desirable
Should have proven technical expertise and hands-on experience with development, execution, and troubleshooting of cell based functional cell based assays
Helpful to have mammalian cell culture experience and familiarity with some detection technologies such as ELISA (Direct and Indirect sandwich formats), Luminescence, Colorimetric, and/or LC/MS/MS detection platforms

201

Principal Scientist Resume Examples & Samples

Design, validate and/or execute new analytical methodology supporting large molecule biologics, including all necessary procedures, instrumentation, training, and regulatory documentation
Participate on project teams as member, lead, or liaison to facilitate team activities and achieving goals
Recognize potential improvements, recommend associated actions, develop and implement appropriate solutions
Serve as primary technical expert for related analytical job area representing the company and associated partners
Manage, schedule and coordinate group activities to meet specified departmental and corporate goals and timeframes

202

Principal Scientist Resume Examples & Samples

Strong formulation background with sound understanding of the excipients
Familiarity with manufacturing processes (blending, granulation, compression, and coating)
Experience with both immediate and controlled release dosage forms
Statistical inference
Physical testing methods (e.g., dissolution, rheology, particulates and/or particle size)
Familiarity with cGMP, GLP, FDA, ICH guidance

203

Principal Scientist Resume Examples & Samples

PhD in relevant field and 5-10 years of relevant experience (preferred); or
Master’s/Bachelor’s degree in relevant field and 10-15 years of relevant experience (preferred)
Expert knowledge of GxPs and industry guidance documents
Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings,

204

Principal Scientist Resume Examples & Samples

Develop and execute the strategy for the successful, timely and cost-effective development of winter wheat parent lines for the hybrid program targeting the Central Plains and surrounding region
Supervise Wheat Breeding staff, budgets, and resource allocation to build a strong functional team to provide robust yield data for breeding decisions that keep projects on-time and on-cost
Implement the Wheat seed business strategy and coordinate efforts with other scientists; Agronomy, Cereal Quality, Pathology, Hybrid Breeder, Introgression Breeder, Discovery Breeder and Biometrics
Manage the activities of the Early Generation Breeder such as marker assisted backcrossing, genotyping, quality testing, database management and other projects as they develop
Contribute to the establishment of hybrid products and database management
Ensure compliance and participation of Safety, Stewardship and Regulatory policies, while setting high standards of professional conduct
Interact with other BayerCrop Science wheat breeding and research teams to further research efforts, and enhance the spectrum and success of the BayerCrop Science wheat programs globally
Travel as needed domestically and internationally, 25%
B.S. with minimum of (12) twelve years’ relevant experience, M.S. with (10) ten years’ relevant experience or a Ph.D. with (6) six years’ experience in Plant/Molecular Breeding or related scientific fields (i.e. Agronomy, Genetics, Horticulture, etc.)
Strong computer, analytical and creative skills are need to analyze data, prepare management updates and crop site literature for visits of breeders, growers and others
Working knowledge of variety testing, statistical analysis and experimental design
Experience in budget and personnel management
People management skills that include hiring, coaching and facilitating disciplinary action
Organizational and time management skills
Critical and logical thinking ability to plan present and future needs
Knowledge of Microsoft Office, including Excel, Word, Visio, and PowerPoint. Ability to learn new database and related computer systems

205

Principal Scientist Resume Examples & Samples

Collaborate with biologists and bioinformaticians to help design experiments that are appropriately powered
Work with bioinformatics team members and contribute statistical expertise to joint projects across the bioinformatics department
Work proactively with stakeholders to address problems relevant to hypothesis testing and biomarker validation in a range of biological contexts with a focus on human genetics
Develop and/or modify bioinformatics methods (including statistical methods) to analyze NGS data, including cutting edge NGS technologies. Demonstrate validity of methods through prototypes

206

Principal Scientist Resume Examples & Samples

Development of machine-learning algorithms and methods for next generation sequence analysis in Oncology
Collaboration with experimentalists to develop analysis tools for early development activities
Implementation of software best practices product life cycles

207

Principal Scientist Resume Examples & Samples

Develop and refine variant detection algorithms to analyze ultra-deep NGS data for oncology diagnostic applications through statistical modeling of error distributions and experimental covariates, empirical benchmarking, optimization and comparison of algorithmic approaches
Analyze and interpret clinical data including extensive data QC, variant call filtering and predictors of clinical endpoints to demonstrate the clinical utility of oncology products, and validate bioinformatics pipelines with real world samples
Work closely with experimentalists to develop analysis tools and automation that will aid in optimization of NGS library preparation protocols. Perform statistical meta-analyses of sources of variation affecting assay performance
Work with software teams to optimize and translate research software into production standard, including documentation, testing frameworks and modular design
Communicate results of bioinformatics analyses to bioinformatics groups, experimental groups, and cross-site collaborators

208

Principal Scientist Resume Examples & Samples

Ph.D. degree with 6+ years or BS/MS degree with 12+ years of pharmaceutical experience
Author analytical procedures, method development, validation and transfer protocols and reports, technical reports, experimental designs, and regulatory submission documents, etc
Identify and champion continuous improvement for the existing workflows
Have working knowledge of API and Drug Product development and commercialization and understand the needs related to commercial quality control
Demonstrate strong collaboration and influence skills with cross-functional partners both internally and externally
Have experience working with CMO’s and CRO’s

209

Senior Scientist / Principal Scientist Resume Examples & Samples

Design, development and prosecution of high quality SPR assays
Proactive communication and partnership with other groups within and outside own functional area to gain credibility and impact in science, technology and project progression
Keep abreast of and implement technology developments within the area of biophysical techniques for understanding the molecular interactions and kinetics of potential therapeutics
Maintain and develop external networks and connectivity with academic, clinical and biopharmaceutical communities

210

Principal Scientist Resume Examples & Samples

In-depth knowledge of cardiac anatomy and physiology
Experience working in a cross-functional team focused on the design and development of a medical device or therapeutic procedure
Experience working in both early-stage and established research and development projects
BS degree in biomedical engineering, biotechnology, physiology with an engineering emphasis or mechanical engineering with life science emphasis
7-10 years medical device experience with BS
5-8 years medical device experience with MS/PhD
In-depth knowledge of cardiac anatomy, physiology and the associated cardiac disease etiologies
Experience with cardiovascular imaging, processing and analysis
PhD in biomedical engineering, biotechnology, or physiology with engineering background
Experience conducting animal research, including pre-clinical GLP studies
Experience working with both healthcare professionals and medical data
Implantable mechanical cardiac device experience
Experience in both catheter based and surgical based therapies, with design experience
Track record of invention disclosures and scientific publications

211

Principal Scientist Resume Examples & Samples

Responsible for protecting the rights, safety and welfare of study participants
Responsible for ensuring that the clinical trial is conducted according to the investigational plan and all applicable regulations
Review and evaluate protocols and provide clinical and scientific support
Liaise with sponsor regarding study design and site capabilities
Interact with regulatory bodies as relevant to clinical operations
Attend study initiation meetings
Present protocols at Institutional Review Board (IRB) meetings, as required
Assist relevant departments with Sponsor visits
Inform IRB and Sponsor as appropriate of relevant events
Delegate the above as appropriate
Support Scientific Affairs Director(s) in Presentations to Clients, client visits, and Laboratory Tours
Support Scientific Affairs in establishing and keeping current Test information databases, and sources of literature and information required to support customers
Develop and validate new analytical methods required for the clinical trials business
Work with Laboratory staff to ensure smooth method set-up and transfer for routine use
As part of the Scientific Affairs group, respond to client and Clinical Trials staff from Europe and US on all technical requests. Technical requests may include: Principles of laboratory tests, details on sample requirements, testing location, location of referral laboratory and cost of testing and result interpretation
Support Scientific Affairs Manager/Director in the interpretation of Laboratory data from clients studies & review for trends
Work with US colleagues on ensuring standardization of methods and reagents at US and European sites
A PhD in molecular biology or related subject plus 5+ years post-qualification experience
Must have experience in a clinical laboratory, pharmaceutical, or related industry
Must have extensive knowledge of and experience with molecular biology techniques, assays, etc
Excellent Communication (interpersonal, verbal, written, and presentation) skills
Excellent computer literacy required (Microsoft Office, Word, Access, and Excel)
Ability to research new projects through Literature searches using library and Internet
Knowledge and / or experience of Pharmaceutical Drug development process and conduct of clinical trials preferred
Knowledge of Pharmaceutical / Diagnostic Industry regulations
Ability to write concise project plans and final reports

212

Principal Scientist Resume Examples & Samples

Demonstrated project management expertise. Ability to manage multiple activities simultaneously and prioritize across projects
Team leadership abilities, particularly in a cross-functional, matrixed environment
Greater than 10 years of analytical or technical development experience
Experience coordinating CMC activities for gene therapy products
Demonstrated professional maturity and breadth of experience

213

Principal Scientist Resume Examples & Samples

Exceptional technical and problem solving skills
Deep knowledge and experience in the application of predictive modeling to solve problems in the pharmaceutical or biotechnology industry to enable internal and external decisions
Experience in presenting to Reimbursement, Regulatory or Health Agencies
Strong record of scientific presentations and research publications in peer-reviewed journals
Excellent communication skills (oral and written) are expected

214

Principal Scientist Resume Examples & Samples

At least six (6) years of experience in biotechnology-related position (vaccines and/or therapeutic proteins) after graduation
Must have a strong scientific understanding and hands-on experience with fermentation and/or mammalian cell culture development and process scale-up
Previous experience in processing of live virus, vaccines and biologics, and fermentation / cell culture equipment
Must have in-depth knowledge and experience with aseptic production of vaccines and/or therapeutic proteins

215

Principal Scientist Resume Examples & Samples

Experience in the areas of GMP assay validation and GMP testing in a pharmaceutical environment, preferably for gene therapy products
Practical knowledge and application of GMP regulations. Ability to manage all aspects of assay transfer, validation and testing in accordance with current guidelines and in compliance with regulations (e.g., FDA, EMA)
Demonstrated project leadership skills and ability to develop effective working relationships with internal/external sites and cross-functional project teams
Experience negotiating with and managing outsourced services

216

Principal Scientist Resume Examples & Samples

Performs background literature research and pre-formulation studies
Designs experimental plan, formulation development work on Oral Controlled release and immediate release dosage forms
Generates, reviews, analyzes data and makes scientific conclusions and recommendations
Designs and executes Quality by Design (QbD) and Design of Experiments (DoE) principles in product and process development experimentation
Performs appropriate documentation and prepares pharmaceutical product development report (PDR), Quality overall Summary (QOS) and other necessary documents to support regulatory filing of ANDA’s
Applies extensive technical expertise and has extensive knowledge of various formulation development approaches. Develops innovative technical solutions to complex problems
Communicates and presents development activities, findings and recommendations to the work group team and management
Plans bioequivalence studies on drug product and evaluates the bioequivalence data to recommend changes in formulation, if needed
Provides support to PharmTech Team for technology transfer to commercial manufactuing sites and process validation
Conducts complex formulation experiments to test, prove or modify applications based on applied research. Manufactures pivotal batches produced for biostudies and FDA submissions
Evaluates complex technical issues to introduce new concepts, products, equipment or processes to develop new applications. Generates documentation to support submission of new products to the FDA
Mentors and assists junior scientists/Technicians. Provides scientific and technical direction to junior staff members (Scientists, Technicians & Operators) to ensure project deadlines and performance standards are met. Collaborates with supervisor to set priorities and reach objectives
Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensures compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), all Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulatins and guidelines

217

Principal Scientist Resume Examples & Samples

LC/MS/MS bioanalysis of small molecules (triple-quad and accurate mass), including method development and optimization
Data analysis, presentation and interpretation
Familiarity with enzyme-based or cell-based assays, including in vitro ADME assays, a plus
Some familiarity with lab equipment such as centrifuges, automated liquid handlers, plate readers
Proficiency with software such as Microsoft Office (Excel) and lab instrument-related (such as Analyst)
Excellent communication (written and oral) and collaborative skills
Proactive and self-driven attitude
Independence in data analysis and effective experimental design
Effective trouble-shooting and problem solving skills
Ability to train and mentor staff

218

Principal Scientist Resume Examples & Samples

Proficiency with lab data software, including compound receipt and tracking, bioanalytical data storage and processing, and data reporting
Integrating automated processes such as barcoded plate and plate maps, generation of cherry-pick plates, integration with lab automation software, and data capture and reporting (for example, ActivityBase, Spotfire, or similar)
Familiarity with LC/MS/MS bioanalysis, particularly with bioanalytical data handling and processing
Familiarity with high-throughput screening (HTS) data from enzyme-based or cell-based assays (including in vitro ADME assays) a plus
Some degree of independence in planning and implementation of data generation and analysis tools

219

Principal Scientist Resume Examples & Samples

In the capacity of DSE project representative
Work with the Therapeutic Area Head to design and implement the toxicology strategy for supported programs
Design toxicology studies and ensure they are performed in accordance with program timelines
Communicate significant toxicology findings to DSE management and program teams
Author toxicology summary documents for submission to worldwide regulatory authorities
As needed, respond to non-clinical toxicology questions from worldwide regulatory authorities
As needed, lead investigative efforts to address/resolve program-related toxicology issues/concerns
Review and edit toxicology study protocols and reports for supported compounds with regard to scientific design, regulatory compliance (GLP, animal welfare and safety)
Provide scientific collaboration to exploratory and discovery groups within Research and Development to help evaluate and nominate drug candidates with minimal or predictable toxicity profiles
Active participation in DSE-wide scientific discussions for compounds across the portfolio
Continuously evaluate and apply new scientific methodology in order to maintain scientific excellence, to increase productivity, to meet our research and drug registration needs, and to minimize or resolve toxicity-based problems with company products or those under development
Act as the toxicology subject matter expert for due diligence evaluations
As needed, act as Study Monitor for toxicology studies conducted at contract laboratories
Ensure compliance with all company/departmental policies, particularly those relating to animal welfare and employee safety and health
Embrace/demonstrate BMS Core Behaviors
Ensure good housekeeping and a safe work environment by enforcing departmental policies and procedures
PhD (or equivalent) degree with minimum 10 years appropriate post-degree experience or equivalent scientific background in the biopharmaceutical industry. Diplomate of the American Board of Toxicology (DABT) is preferred
Experience serving as a toxicology representative on development and discovery teams across different stages of development, including participation in global Health Authority interactions
Experience with toxicology testing of both small and large (biologics) molecules
Knowledge of biochemical and mechanistic toxicology, and ability to design and interpret studies exploring mechanisms of toxicology involving biochemical, functional, and/or structural endpoints
Knowledge of human risk assessment, as it pertains to applicable discipline
Effective written and oral communication skills, especially as they pertain to writing clear, and accurate toxicology reports and summary documents for global regulatory submissions
Ability to independently integrate and write nonclinical submission documents
Ability to effectively communicate and interact with co-workers at all levels and to work independently and on teams
Knowledge of Standard Operating Procedures, Good Laboratory Practice, worldwide and regulatory requirements, and drug development processes

220

Principal Scientist Resume Examples & Samples

Represents SALAR on discovery teams and participate in therapeutic area discovery governance committee reviews when appropriate
Identify and assess potential risks associated with therapeutic targets or development candidates using available literature, internal data, and external information
Define the appropriate in silico, in vitro and in vivo studies, including the design, dose selection and timing to help innovate and select candidates with the highest probability of success, and collaborate with SALAR and discovery scientists to assure the appropriate conduct of these studies
Collaborates with the discovery and SALAR scientists to address other scientific issues including assessment of efficacy, metabolism, formulation and purity of drug product and substance
Work closely with the SALAR development compound leaders and therapeutic area leaders to align on development plans, to facilitate a smooth transition of discovery programs into development and to assure the highest probability of success for the initiation of first into man studies
Minimum 5 years of pharmaceutical industry experience as a non-clinical safety assessment scientist (e.g. Toxicology, Pathology etc.) and/or as non-clinical safety assessment representative to a cross-functional development and/or discovery team
Demonstrated ability to successfully navigate cross-functional lines and drive team decision making in a matrix organizational structure
Highly dedicated, motivated, resilient and flexible; capable of creative problem solving and delivering on goals and objectives in a timely fashion in a scientific business model setting
Excellent team player who is able to work collaboratively with discovery team members from various functions, other SALAR DPLs and SALAR scientist responsible for study conduct and portfolio management in the development space towards common objectives
Excellent interpersonal skills and able to establish good working relationships within networks of employees of all levels and personalities fostering cooperation in others

221

Principal Scientist Resume Examples & Samples

10%:Perform high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards
10%:Assess progress relative to objectives and communicate progress periodically to supervisor and key stakeholders within and outside Group
10%:Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication

222

Principal Scientist Resume Examples & Samples

Proficiency with lab equipment and high-throughput, including programming and optimizing robotic methods
Experience performing enzyme-based or cell-based assays on an automated platform (familiarity with in vitro ADME assays such as metabolic stability, protein binding, and permeability a plus)
Experience preparing samples for LC/MS/MS bioanalysis a plus
Data analysis, presentation and interpretation a plus
Proficiency with software such as Microsoft Office (Excel) and lab-related (such as Prizm)

223

Principal Scientist Resume Examples & Samples

Ph.D. or equivalent in Biomedical Informatics, Computer Science, Electronic Engineering, Data Science, Statistics or related quantitative fields
10+ years of research and development experience on healthcare data analytics (clinical data, claim data, physician quality reports, and workflow data) with a track record of scientific achievements and commercial successes
5+ years of hands-on experience of predictive modeling with large and complex healthcare datasets in a scalable architecture
Excellent knowledge in multiple data analytics and visualization tools (R, Python, MATLAB, Tableau, AWS, etc.)
Strong knowledge on clinical cardiology workflows, healthcare information systems, interoperability, accreditations, quality assurance, care programs in hospitals and integrated delivery networks
Track of record in successfully leading multiple remote multidisciplinary teams
First author publications in top data science journal/conference
Strong knowledge and successful experiences on data-driven service (model) innovation

224

Principal Scientist Resume Examples & Samples

Lead a group of scientists and research associates for assay development and method validation to support nonclinical and clinical PK/PD-Biomarker
Interact with the functional teams within the department as well as outside groups to represent GBT PK/PD-Biomarker functional area
Provide technical expertise, strategies and make decisions for PK/PD-Biomarker needs
Review clinical study protocols, reports and regulatory submission documents
Oversee outsourced works to ensure the delivery of the highest quality data within timeline and budget

225

Principal Scientist Resume Examples & Samples

Aligns project and team goals with the company’s business vision
Develops product concepts aligned with customer requirements and product specifications, and translates them into focused scientific activities
Plans, designs, and executes advanced independent or multi-disciplinary research/development experiments driven by strategic business needs
Manages projects and team, provides scientific/technical direction, and designates accountability for product research and development activities. Gives people assignments and training to develop their abilities
Serves as a subject matter expert at various management levels. Prepares timelines and assessments of project progress and critical factors, and establishes priorities. Assumes responsibility for timely completion of projects, and resolves technical issues
Ensures activities meet performance/quality expectations and are consistent with project critical path
Ensures technical activities under delegated supervision are conducted within of internal and external guidelines and regulations
Interacts with other departments to further project goals. Responsible for the transfer of prototype product technology and documentation from Research to Development and/or to Manufacturing. Provides information and assistance to other departments to support product scale-up, manufacture, launch and sales
Recommends new approaches, expansion or curtailment of project technical activities based on experimental results or new scientific information. Adjusts direction of research activities accordingly as scientific findings warrant
Communicates progress of efforts to Director and other departments to assure awareness of current status of projects. Provides top line review of experimental results, and secondary review of experimental data. Prepares comprehensive written and verbal project status reports, and written manuscripts for publication in some cases. Presents findings or comprehensive project status reviews at internal & external meetings. Applies advanced technical writing skills to produce reports and documents
Influences senior management decisions that have an impact on business direction of the area. Makes decisions under consultative direction that have an impact on business direction of the area. Decisions have a long term effect on the objectives of the function and/or area

226

Principal Scientist Resume Examples & Samples

Provide expertise in biochemistry and protein engineering
Perform hands-on high-throughput screening to engineer enzymes with favorable kinetics for nanopore sequencing
Ph.D. in biochemistry, biophysics or related discipline
Technical expertise in fluorescent plate-reader assays and stop-flow kinetic assays is a must
Prior experience with high throughput enzyme engineering is a plus
Expertise in protein expression, purification, and characterization is a plus
Enjoys working independently under general direction in a fast-paced environment
Strong oral and written communication skills and good team work

227

Principal Scientist Resume Examples & Samples

Leads in designing and implementing experimental studies and concepts to develop crystallization and isolation processes to deliver target slid form, chemical purity and other identified critical quality attributes
Conduct engineering analysis (experimental and/or modeling) to probe potential scale-up issues and design solutions for crystallization and isolation
Conduct particle engineering studies to support powder property scouting activities
Conduct risk assessment and robustness studies for late stage crystallization and isolation processes
Troubleshoot manufacturing issues through collaboration with late stage development and/or CMO
Responsible for technical reports and quality in a timely manner
Function as an acknowledged resource and technical leader within and outside MAS in a specific project relevant area or technology; demonstrates appropriate scientific and regulatory knowledge. Provide guidance and expertise to advance R&D projects or evaluates and proposes new technologies and concepts, in support of multiple R&D projects
Demonstrates broad knowledge in field of expertise. Keeps abreast of relevant literature and its interpretation; develops visibility outside of functional area
Complies with all applicable regulations. Ensures that work performed in area of responsibilities is conducted in a safe and compliant manner. Manage all aspects of laboratory operations

228

Principal Scientist Resume Examples & Samples

Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery and development of elegant chemical syntheses and processes for active pharmaceutical compounds
Represent Drug Substance Development (DSD) on multidisciplinary Chemistry Manufacturing, and Controls (CMC) teams with direct scientific responsibility and oversight of DSD staff
Apply fundamental chemistry and engineering principles to solve challenges in synthesis and process development from bench through pilot plant manufacture
Develop and execute phase appropriate risk-based development and drug substance supply plans
Manage technology transfers to and support manufacturing of GMP Drug Substance (DS) at Contract Research Organizations
Conduct DS related due diligence assessments for potential external collaborations
Serve as Celgene DSD representative on external collaborations
Prepare technical reports, publications and oral presentations
Enhance the scientific and business capabilities of the department
Ph.D. in Organic Chemistry with 8 + years relevant industrial experience
Excellent laboratory skills and knowledge of organic synthesis. Proficient in the use and interpretation of NMR, HPLC, MS, IR, DSC, TGA, XRD, and automation
Proven track record in developing and scaling-up innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances. Demonstrated record of implementing creative solutions to overcome synthetic and manufacturing obstacles
Extensive patent and academic journal publication record a plus
Ability to balance scientific, legal, and business needs as they relate to a given project
Ability to balance multiple projects at different levels, must be able to concomitantly work effectively in the lab and as a project manager
Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary team environment. Ability to work independently or in team environments under deadlines
Excellent verbal skills are essential, must be able to contextualize complex issues for colleagues in and outside of the department
Solid writing skills are critical, must be able to succinctly capture technical and project related information from diverse sources
Experience with CMC issues encountered in drug development
Familiarity with GMP manufacturing and regulatory filings
Direct or indirect supervisory experience

229

Principal Scientist Resume Examples & Samples

Lead, plan, execute and present analytical development in support of phase III/pivotal studies
Analytical lead: Planning, reporting, budgeting and forecasting on managed projects
Outsource, lead and coordinate analytical development activities at CROs/CMOs including selection, writing contracts (SOWs), oversight and technical support
Writing/reviewing, raw data, protocols, reports, SOP’s, specifications, risk assessments and regulatory documents
Support and mentor scientists supporting the projects
Provide analytical development expertise to influence decisions on scientific/technical issues related to assigned internal and/or outsourced projects
Work according to safety and quality regulations/guidelines (SOPs)
Participate in technology transfer to Product Supply
Acting on behalf of Director within defined scientific tasks/activities

230

Principal Scientist Resume Examples & Samples

Minimum education: BSc physical sciences or engineering; post-graduate degree preferred
Minimum 6 years direct or related research experience, preferably in an industrial R&D setting, with electrochemical sensors, assay design, reagents, disposables and instrumentation development
Knowledge of Design Controls with respect to development of medical device products including but not limited to: Planning, Input requirements, Outputs, Design Reviews, Verification, Validation, Design Transfer, Change Control and Design History File
Knowledge of FDA regulations for in vitro diagnostic manufacturer is an asset
Strong protocol design, technical writing skills are critical for this position
Knowledge of electrochemical sensor design, manufacture and performance is an asset

231

Principal Scientist Resume Examples & Samples

Designs experiments to test hypothesis related to project outcomes, and analyzes and interprets data/results, recommending new or creative approaches, and/or expansion or curtailment of investigations based on experimental data or new scientific information arising from area of responsibility
Presents findings or comprehensive project status reviews at internal seminars/meetings. Applies advanced technical writing skills to produce reports and documents for internal and external purposes, including regulatory filings and publications
Assumes responsibility for timely completion of projects, ensuring activities are consistent with project critical path and responding appropriately to changing priorities
Ensures technical activities under delegated supervision are conducted within internal and external guidelines and regulations
Serves as an expert resource to other departments (e.g., Manufacturing/Operations, Quality, Marketing, Regulatory Affairs, Clinical Studies, and International Technical Services), providing timely response and follow-ups, in order to further project goals. Interacts with senior personnel from other Roche companies on significant matters requiring scientific and project cooperation
Participates in the expeditious transfer of products and technologies by providing scientific knowledge and assistance. Provides technical advice/guidance to junior scientific staff, and serves as a role model
May include management of personnel with full HR responsibility for direct reports. May act as lead for project teams of moderate size and complexity

232

Principal Scientist Resume Examples & Samples

Initiates DP process assessments early on and collaborates with Pharmaceutical Development (PD) to create iDeal strategy. Collaborates with API teams (PD, TTT, etc) to ensure delivery of appropriate and robust DP manufacturing process
Analyzes trends and sensitivity in API/DP process/equipment performance from development to launch. Performs risk assessments to evaluate the probability and impact of risks, establishes mitigation strategies and provides input and maintains the product risk register and related risk mitigation activities
Reviews and develops DP characterization and testing plans and interacts with EXM-MS&T and PD if any issues arise
Monitors DP performance with respect to changes in material properties or processes. On request participates in teams, programs or other company initiatives
Bachelors(Required)
Doctorate,Masters would be a plus
Experience in Matrix Management Experience for minimum 1 year

233

Senior Scientist / Principal Scientist Resume Examples & Samples

Responsible for analytical readiness for process validation/PPQ campaign (drug product and drug substance) for late stage pipeline products
Accountable for analytical method transfer from Medimmune’s Biopharmaceutical Development to commercial manufacturing sites within AZ Biologics operations as well as outside testing laboratories
Establish harmonized processes and best practice on various global analytical activities within Biologics
Technical support for new business opportunity, due diligence and direct technical support as needed at the site level in a consulting or SME role
Responsible for ensuring harmonized compliance to internal standards and policies related to analytical operations across all biologics manufacturing sites
Coordinating collaboration via a cross site analytical forum
Author technical documents in the subject matter for regulatory submissions
Provide input and review for regulatory filings in order to ensure consistency in depth of content and strategic approach
Response to regulatory agency questions on analytical related issues
Strong Project Management and interpersonal skills
Extensive knowledge and experience with a variety of analytical techniques for biologicals
Familiar with regulatory guidelines and current industry trend
Maintains high level of expertise through review of current scientific literature, submissions to scientific journals, and attendance and participation at conferences focused on the research and development efforts of the company
Displays a general knowledge of manufacturing process, drug development, and cGMP requirement
Has a working knowledge of biosafety testing and microbiology requirements in a manufacturing environment
For Senior Scientist, PhD 6-10 years relevant experience, MS >12 years, or BS >14 years
For Principal Scientist, PhD with 10+ years relevant experience, MS >15 years, or BS >17 years
New Product introduction/late stage product development experience in Biologics
Analytical method development, qualification, validation and transfer
Global commercial Quality control
Must have significant experience with most of the following standard analytical techniques used in the biopharmaceutical industry: e.g., UV-Vis, HPLC, LC-MS, GC, FT-IR, SDS-PAGE, IEF, CE, ELISA, mass spectrometry, bioassay
Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements
Good understanding of biosafety assays, cell bank testing, and microbiological requirements in a manufacturing environment
Experience in process and analytical technology transfer within and between organizations, manufacturing support and troubleshooting
Demonstrated teamwork, organizational, and leadership skills
Proven ability to influence across functions and organizations
Project management skills and strong technical writing skills

234

Senior Scientist / Principal Scientist Resume Examples & Samples

Knowledge of the principals and practices of pharmaceutical sciences combined with professional experience in developing and testing formulation processes in more than one dosage form or product category
Expert with QbD principles
Expert in writing parts of ANDA submission relevant to the formulation / process development
Sound problem solving skills and good scientific judgment are required
Good communication skills and the ability to work on interdisciplinary teams are required
Hands on small scale equipment and good understanding of large scale conventional pharmaceutical equipment is required
Familiarity with project management methodology is necessary
These skills are acquired through completion of a Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with 6 to 10 years of research experience in the pharmaceutical industry, or a Master’s degree combined with 4 to 6 years of relevant research experience, or a doctoral degree combined with up to 2 - 4 year of relevant research experience

235

Principal Scientist Resume Examples & Samples

Background in cancer biology or immunology, with understanding of MM or related hematological malignancies preferred
Knowledge of the clinical landscape, evolving therapy, competitive scenario is desirable
Basic understanding of late-stage drug and translational development
Strong verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, disease strategies, mechanism slides, regulatory submissions, strategic communications, literature/market/pt segment analyses
Proven scientific/project leadership expertise (working in teams, managing people/projects)
Ability to synthesize complex scientific and business problems into strategy and tactics
Ability to tailor communication to different audiences (scientists, clinicians, cross-functional teams) and in different mediums (written documents, slides)
Ability to independently research scientific questions in the literature, summarize relevant findings, and draw hypotheses or conclusions based on available data
Experience in writing or developing disease and/or brand planning strategies, regulatory documents for in-line and late-stage development compounds in disease areas, preferably in MM, is ideal, but not required
Ability to learn and follow Celgene guidelines and processes (eg, Celgene Style Guide) for technical documents as well as appropriate regulatory style (ie, for responses to US and EU regulators)
Supports regulatory submissions in conjunction with other TD scientists including regulatory interactions, writes translational sections for regulatory responses and answers to regulatory queries for the TD group
Writes scientific / technical reports for non-GLP translational biomarker/correlative studies conducted by or on behalf of Celgene
Works independently and with other relevant line functions to prepare/review scientific summaries and regulatory documents and submissions, including: nonclinical summaries for IND, NDA, and CTD applications to Health Authorities, white papers, Investigator Brochures, product monographs/package inserts, and responses to health authorities
Authors TD publications (abstracts, posters, manuscripts, presentations) in conjunction with other TD scientists for internal and external meetings and congresses
Reviews data to determine the appropriate tabular and textual formats, and clarity, logic and order of presentation
Be an expert user of the templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines
Contribute to the authoring, review, and approval process for documents within an electronic publishing system in conjunction with NWD Document Specialists and Regulatory Operations departments
Assists with organization, development, and tracking of disease specific translational annual goals and objectives for the late group (for internal /external, - translational collaboration, compound specific plans etc)
Represents Translational Development in cross-functional strategy teams as needed
Interfaces with Drug Safety to provide scientific support that aligns with TD, brand, and disease strategy for post-marketing safety requests and other queries related to approved and in-line products. This includes researching, writing, and presenting data within TD and to cross-functional teams, as needed
Participates in translational research in the Summit lab of Celgene
Strong background in cancer biology, especially hematological cancers
Ability to work with multiple complex projects and within cross-functional teams
Demonstrate in-depth, scientific-directed, innovative thinking
Excellent technical scientific writing and verbal communication skills required
Experience as a nonclinical toxicology, pharmacokinetics, and/or pharmacology writer that included contributions to Investigational New Drug (IND), New Drug Application (NDA), and/or Common Technical Documents (CTD) and electronic document submissions (eCTD) for FDA and worldwide regulatory documents is preferred
Proficiency in use of Microsoft Word, Excel, Adobe Acrobat, and web-based browser software such as LiveLink to manage electronic document authoring, reviewing, and approval process
Some experience with supervision and mentoring of scientific staff is desirable

236

Principal Scientist Resume Examples & Samples

Leads Clopay Plastics Products in the development process of up-to-date technology relating to our processes. Manages and executes all facets of process and product development research to support the commercialization of major product development projects
Defines process parameter and control needs to meet customer product requirements
Develops improved understanding between pilot and production line differences
Leads a project team, which may include Sales/Marketing, Manufacturing, Engineering, Customer Service and other areas
Supports PPC Mission and Five-Year Plan in the area of product development and other areas as required
Supports manufacturing plants on technical process issues as required
Participates in trade and professional organizations that are relevant to Clopay’s business. Keeps the company up to date on new technology related to our processes
Supports safety and quality system efforts
Responsible for process research leading to the commercialization of new products and the improvement of existing products. Process research typically takes place in a team context, and often includes multiple employees from multiple Clopay facilities working on a given project. * Employee shall cooperate with the Company and its affiliates in the documentation, protection, and commercialization of such research and developments to the extent requested by the Company. In particular, to the extent that the Company wishes to seek patent protection as to such inventions, Employee shall cooperate with the Company in securing such protection
Bachelor's of Science degree, majoring in Chemical Engineering, Mechanical Engineering, Polymer Science, Polymer Engineering or Processing or equivalent required. Master's Degree or PhD a plus
A Minimum of six to ten years of extrusion and/or converting experience
Demonstrated leadership skills in defining and implementing process optimization for extruded products to meet customer product requirements
Experienced in the processing of polyolefin or styrenic block copolymers. Knowledge of material selection for co-extruded films. Ability to interact with and lead project teams composed of diverse team members
Required to travel 10-25% domestically and limited international travel
May be required to lift up to 25 pounds

237

Principal Scientist Resume Examples & Samples

(40 %) Explore and implement new and innovative solar technologies
(10 %) Evaluate cutting edge solar component suppliers
(10 %) Provide technical direction in development of unique solar products
(10 %) Develop proposals to work with outside agencies and research institutions
(10 %) Recommend appropriate certifications for assuring product performance
(10% ) Report on solar technology progress in monthly reports
(5 %) Make interim presentations to cross functional teams and senior R & D staff
(5 % ) Candidate needs to be self-motivated and needs to be a team player
Knowledge of photovoltaic materials and cells
Good understanding of solar industry and component manufacturers
Ability to recognize changing technologies and make appropriate corrections
Demonstrated ability to make compelling case for technical recommendations
Knowledge of roofing or roofing industry experience is plus
Should have strong communication and interpersonal skills
Needs to be a good team player
Ph.D. in Engineering or equivalent (Mechanical, Electrical, Chemical or Materials)
5-7 years of experience in design / development of solar products and technologies

238

Principal Scientist Resume Examples & Samples

Performing a large variety of analytical tasks for the development and validation of analytical methods used in the testing of drug products, active pharmaceutical ingredients and animal health products by means of various procedures including HPLC, GC, UV/Vis, and dissolution
You will be required to read, understand, and interpret diverse analytical procedures presented in a variety of written styles, as well as to write protocols and to oversee the implementation of new techniques. This would also include the ability to read, understand, and comply with all written protocols and SOP’s
We may ask your to serve as a systems administrator; conduct investigations in support of our clients needs, which will include mass spectrometry, documenting work clearly and performing tests accurately. Which would place you in a position to speak to our clients as needed
GMP/GLP experience and knowledge is required, as you will need to document all testing, observations, deviations, and results clearly and completely
The ability to manage multiple projects as assigned, to train others on laboratory procedures and mentor peers, as well as to evaluate new technology as received
Eight years of pharmaceutical industry experience with a Bachelor’s, five years with a Master’s, or two years with a Doctorate
Method development/validation experience with HPLC, UPLC, and GC

239

Principal Scientist Resume Examples & Samples

Assumes leadership role for either project teams OR acts as a representative on multiple project teams and contributes to overall program goals
Functions as an acknowledged resource and technical leader within and outside of the department in a specific project-relevant area OR technology; Provide guidance and expertise to advance specific R&D projects OR evaluates and proposes new technologies and concepts, in support of the advancement of multiple R&D projects
Demonstrates broad knowledge in field of expertise, the ability to interpret current literature and apply to relevant R&D projects Complies with all applicable regulations; Ensures that work performed in area of responsibility is conducted in a safe and compliant manner; Maintains proper records in accordance with SOPs and policies
Provides administration within area of responsibility including: recruiting, managing, mentoring and developing scientific staff; Provide assistance in the preparation and management of operating and capital equipment budgets, as required
Build and lead a research team with highly motivated and qualified lab scientists
Establish biochemical assays and reagents and in vitro immunological assays to enable the discovery of biotherapeutic agents for autoimmune diseases and cancer immunotherapy, and profiling of drug candidates
Co-Lead portfolio projects towards the discovery of innovative immune-modulating biological drugs
Collaborate and coordinate effectively with other research teams and disciplines across a global Discovery Research organization
As a member of a global expert working team contribute to the proposal and evaluation of new therapeutic drug concepts for cancer immunotherapy
Present scientific data at internal and external meetings, and publish findings in peer-reviewed scientific journals
Establish and manage external collaborations
Independently designs and performs scientific experiments with a predefined goal including developing new methodologies, protocols and or test procedures that contribute to core group/research goals and reflect expert knowledge; Direct and oversee experimental design and results of technicians and junior level scientists
Contributes to defining R&D team goals and collaborates with scientists within and outside functional area in achieving them; Assumes departmental responsibility for projects OR has ability to participate as representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals
Prepares clear technical reports, publications and oral presentations. Independently communicate results in the form of reports and/ or presentations; Deliver updates to senior level management in context of overall project goals
Demonstrates an expertise in a specific project-relevant area OR technology; Provide guidance and expertise to advance specific projects OR evaluate and propose new technologies and concepts in support of multiple projects
Develops broad knowledge in field of expertise, including the ability to interpret current literature relevant to R&D projects, and visibility outside of functional area

240

Principal Scientist Resume Examples & Samples

Lead a molecular/genomics lab that provides genomic/molecular characterization of in vivo disease models (in collaboration with in vivo pharmacology) and human cancer, tissue and blood samples to understand the target-disease link
Profile drug candidates to identify predictive and pharmacodynamic biomarkers. Coordinate effectively with other research teams and disciplines across the global Discovery Research Organization
Contribute to the profiling, validation and initial application of biomarkers in clinical studies
Establish and manage external collaborations with academic partners and CROs, including evaluation of new technologies
Lead a molecular/genomics lab that provides genomic/molecular characterization of in vivo disease models (in collaboration with in vivo pharmacology) and human cancer, tissue, and blood samples to understand the target-disease link

241

Principal Scientist Resume Examples & Samples

Lead a laboratory to develop and validate immunohistochemistry, flow cytometry and ELISA based assays of in vivo disease models (in collaboration with in vivo pharmacology) and human cancer, tissue and blood samples to understand the target-disease link
Establish immunological assays to investigate mechanisms of immune-mediated effects of novel immunotherapeutic concepts during the preclinical development program
Contribute to successful drug development as member of a multidisciplinary team
Establish and manage external collaborations, including evaluation of new technologies

242

Principal Scientist Resume Examples & Samples

PhD in Chemical Engineering, Mechanical Engineering, Physics, or Materials Science
Practical experience within the discipline of Food and Beverage Oral Processing
Demonstrated knowledge of rheology of complex multiphase systems (Physico-chemical behavior and interactions in different matrices)
Proficient in laboratory bench work and analytical instrumentation
Preferred experience in emulsions, colloidal science, surface chemistry and/or polymer science
Demonstrated ability to solve complex technical problems
Ability to analyze data of complex food and beverage systems and translate it for easy consumption for non-rheologists

243

Principal Scientist Resume Examples & Samples

Experience managing major / complex problems or issues that may span across multiple functions or businesses
Develops plans and deliverables with limited management oversight
Strong oral and written communication skills. Interact with various levels of internal and external customers including executive leadership
Proficiency working in a team environment, collaboration across disciplines
Strong technical contributor and experience providing technical work direction, coaching and training to other resources within job scope
Strong Leadership skills and mentoring capabilities
Recognized expert in external medical diagnostic products
Ability to work at various levels of a problem, from the high-level concepts to the clinical, device, or algorithm details
Minimum: Masters in Electrical Engineering, Biomedical Engineering, Physiology, Biology, or DVM with 7-10 years relevant experience
Preferred: PhD Degree with minimum of 5-8 years relevant experience

244

Principal Scientist Resume Examples & Samples

Demonstrate strong synthetic chemistry expertise, use latest scientific advances and creative solutions to solve challenging synthetic issues
Collaboratively support the advancement of compounds through in vitro and in vivo studies to identify development candidates
Collaborate with structure based design groups
Collaboratively engage with the external scientific community
Present data and reports on project status at individual, group, departmental and organizational meetings
Ph.D. in synthetic organic chemistry with 6+ years pharmaceutical/biotech medicinal chemistry industrial experience is required
Post-doctoral experience is preferred
Proven track record of scientific contributions both internally (advancing discovery programs to clinical candidates) and externally (peer reviewed publications, patents, and presentations is required
Independently design and synthesize drug-like molecules utilizing medicinal chemistry knowledge and an understanding of ADME, pharmacokinetics and optimal physicochemical properties is required
Demonstrate independent thinking and the ability to effectively collaborate in a highly matrixed environment is preferred
Excellent oral and written communication skills, including preparation of presentations is required.3986170620

245

Principal Scientist Resume Examples & Samples

Identification and development of new AAV Applications
AAV Capsids development
Vector design
Optimize Vector Cassette
Assist in management of projects with partners and/or contract laboratories
Preferably 10+ years of experience working as a scientist in an academic, research, laboratory setting or biotech/pharma company
Exceptional publication record in leading peer reviewed journals
Experience interpreting and presenting data to internal and external stakeholders, and at national and international meetings
Drug development and/or extensive research training

246

Principal Scientist Resume Examples & Samples

Serve as the department lead person for clinical pharmacokinetics (PK) in studies and project teams
Perform and accountable for non-compartmental PK data analysis
Plan, implement, interpret and report model-based PK and pharmacodynamics (PD) analysis including population PK, PK/PD modeling and simulation, meta-analysis for assigned compounds under clinical development from Phase 1 to 3 and in life cycle management
Assist in selection of doses and dosing algorithms for clinical development
Contribute to regulatory documents and meetings; take a lead role in writing and reviewing response to regulatory queries on clinical pharmacology/PK
Provide input to clinical study designs and PK logistics
Scientific oversight of CROs with respect to PK and PK/PD tasks
Strong quantitative skills with hands-on experience in advanced data analyses, i.e. population PK, PK/PD, and exposure-response analyses
Competent in the use of various modeling software (NONMEM, SAS, Splus, R, etc.) and standard noncompartmental data analysis software (Phoenix/WiNonlin)
Excellent written and verbal communication skills and demonstrated oral presentation skills
Ability to work in a cross-functional team environment and to work simultaneously on multiple projects
Knowledge and experience on clinical database, PK/PD data compilation and manipulation with scripting software of SAS, R and/or Splus
Familiarity with all stages of drug development from discovery through Phase 4, including experience in the preparation of clinical pharmacology sections of regulatory submissions for IND- and/or NDA-stage projects

247

Principal Scientist Resume Examples & Samples

Serve as subject matter expert and leader in the PK/ADA evaluations
Propose strategies and oversee the development of new methodologies, protocols and/or test procedures of immunoassays that meet group goals and reflect expert knowledge of PK and ADA
Contribute to strategy and design for neutralizing anti-drug antibody assays – cell based and plate based methodologies
Independently apply basic scientific principles, attend scientific meetings, and keep abreast of emerging technologies and literature in the biotherapeutic bioanalysis field
Supervise and lead junior level scientists by assisting with experimental design and troubleshooting of bioanalytical challenges
Ensure regulatory requirements (GLP/GCP) and industry practices are followed
Present results at departmental and team project review meetings; may deliver updates to senior level management in context of overall project goals
Act as DMPK representative on multiple cross-functional project teams
Generate written reports and contribute to regulatory submission documents

248

Principal Scientist Resume Examples & Samples

MD/PhD or MA/MS / BSN/RPh +3 years of experience or BA/BS/Technologist Certification +6 years of experience required
9 years of experience in Healthcare, Pharma, or Academia required
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

249

Principal Scientist Resume Examples & Samples

Ph.D. in bioinformatics, biology, genetics, biochemistry, or a similar discipline
7 or more years experience in the pharmaceutical or biotech industries
Previous line management experience preferred
Strong strategic and technical leadership skills
Solid understanding of Immunology
Excellent written and oral communication skills, including an ability to converse with computational scientists, experimentalists, and clinicians
Familiarity with clinical trial design, clinical trial processes, and clinical trial data analysis
Extensive experience analyzing and interpreting NGS data
Hands-on experience with relevant public domain data sets including 1KG, Exac, GnomAD, and TCGA
Fluency with Linux based high performance compute environments, R/Bioconductor, and reproducible research practices
Partner with key stakeholders across the company to set and implement bioinformatics strategy
Recruit and develop talent
Set priorities, balance team workload
Communicate effectively to build support for work and align with organization

250

Principal Scientist Resume Examples & Samples

Lead a group of scientists supporting small molecule drug metabolism/metabolite identification for pipeline projects
Guide strategy, provide subject matter expertise and mentorship for the ADME sciences to your team, project team representatives and project teams
Influence the design of fit-for-purpose metabolite identification studies to achieve an appropriate level of understanding of the disposition of our molecules to best meet therapeutic and safety objectives
Devise, articulate, and implement strategies leading to a cohesive vision for improvement of the clearance and safety properties for candidate molecules
Identify drug metabolites using LC-MSMS and other analytical methodologies (sometimes requiring the use of radio-labelled materials)
Plan, design, and conduct fit-for-purpose in vitro studies and in vivo sample analysis

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