Scientist Principal Resume Samples

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S Mraz

Serenity

Mraz

20681 Tremaine Stream

Detroit

+1 (555) 184 9946

20681 Tremaine Stream

Detroit

Phone

p +1 (555) 184 9946

Experience Experience

Philadelphia, PA

Scientist Principal

Philadelphia, PA

Marquardt-Rippin

Philadelphia, PA

Scientist Principal

Ensures compliance with all Company policies and procedures, including safety rules and regulations
Carries out lead responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws
Maintains a high level of expertise within the field and develops new technologies and concepts to be applied in the development of oral controlled release drug products
Identifies, analyzes and suggests corrective actions to optimize R&D processes, technology and regulatory compliance issues
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities
Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws
Performs background literature research and pre-formulation studies

Houston, TX

Principal Clinical Data Scientist

Houston, TX

Abbott-Heaney

Houston, TX

Principal Clinical Data Scientist

Define and execute Data Quality and Protocol Deviation Management Plans, gaining study team input and applying project standards
Lead the set up of data collection (eCRF, ePRO etc) and in-stream reporting tools for clinical studies within a Project
Drives Cross-Project Data Management collaboration, sharing information and lessons learnt as a Data Management expert within the Data Management Community
Ensures peer review, completion, lifecycle management and archiving of all data management documents
To Interact with study monitors, site medical staff, and data providers on areas impacting data quality
Expert input to the development of data capture tools for a clinical study, including the eCRF and ePRO
Development and management of study validation and integration plans, including the validation plan, dataset definition and external data sources

present

Boston, MA

Data Scientist Principal Director

Boston, MA

Bradtke-Ankunding

present

Boston, MA

Data Scientist Principal Director

present

Execute change management strategy with internal and external stakeholders to achieve a value based mindset
Facilitate the development of “request for proposals” responses and contract development
Apply Accenture standard methods for performing strategy assessments and implementations
Drive the integrated value proposition and work with the client to gain alignment and buy-in
Practice & Offering Management
Develop a strategy for as a service pricing that aligns to Accenture Operations’ overall market strategy
Work closely with leadership to set strategy and define success criteria for any project

Education Education

Bachelor’s Degree in Statistics

Ball State University

Bachelor’s Degree in Statistics

Skills Skills

Strong interpersonal skills and maintaining cooperative working relationships with others
Product formulations, product stability, packaging, and FDA submission methods and practices
Advanced Chemistry, pharmaceutical and statistical theories, methods and procedures
Operating scientific and personal computers
Managing multiple projects, duties and assignments
Coordinating and reviewing the work of assigned department personnel
Coordinating and leading multifunctional teams to ensure successful execution of projects
Innovative, realistic and practical approach to responsibilities, projects, and challenges while being results oriented
Driving for continuous process improvement
Ability to efficiently handle pharmaceutical unit operations, such as fluid bed coater, compression, roller compaction, high shear granulation, particle and tablet coating, encapsulation and packaging

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15 Scientist Principal resume templates

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Principal Medical Writing Scientist Resume Examples & Samples

Bachelor’s degree with a minimum of 7 years of relevant medical writing experience is required OR a Master's degree or other advanced degree with a minimum of 6 years relevant medical writing experience is required OR a PhD or equivalent in one of the biological sciences or related field with a minimum of 5 years of relevant medical writing experience is required
Strong scientific/medical writing skills including the ability to interpret and organize scientific data is required
Experience in writing clinical regulatory submission documents, including Clinical Study Reports, Investigator’s Brochures, Clinical Study Protocols, CTD Summary Documents (i.e., Efficacy and Safety Summaries, Clinical Overviews, etc.), Responses to Regulatory Questions, Briefing Documents, and safety documents such as Risk Management Plans, etc. is required
A working knowledge of clinical study design and biostatistics is preferred
Experience in using applicable word processing (i.e., MS Word, etc.) software is required
Experience working on cross-functional teams in a highly matrixed environment is required
In-depth knowledge of writing guidelines (e.g. ICH, FDA, AMA, etc.) used for the preparation of clinical documents is required
Oncology therapeutic area experience is preferred
Knowledge of the end-to-end drug development process is required
This position will be located in Springhouse, PA, Titusville, NJ, or Raritan, NJ and will require up to 10% domestic travelMedical Writing

Research Scientist Principal Resume Examples & Samples

Work with GAC faculty and staff to develop goals and strategies for data analysis and experimental design
Provide leadership for the analyses of specific projects, including coordination of local staff and external investigators
Stay informed about new methods in statistical genetics and apply them appropriately
Program statistical data analysis of large data sets efficiently using parallel computing and other resources
Summarize and communicate results of analyses to GAC staff and clinical collaborators
Prepare results for publications, work with collaborators in writing publications and, in some cases, take the lead in writing publications
Participate in the preparation of grant and contract applications for research funding
Project and personnel management in scientific research
Publications in statistical genetics or related area

Research Scientist Principal Resume Examples & Samples

Master’s or higher in atmospheric science, machine learning, a hard science, math, statistics or an engineering field, or equivalent work experience. Ability to thrive in a team environment and adapt to quickly changing priorities
Experience working with NEXRAD data
Experience with hail detection algorithms
Expertise and knowledge about radar systems
8+ years of directly related experience
Strong problem solving and analytical ability
Ability to convey complex information into management decision-making presentation materials

Senior Principal Analytic Scientist Resume Examples & Samples

Head up 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
Rapidly develop new analytic innovations, and be able to present them to clients in a compelling way, demonstrating value and differentiation
Focusing on the external communications plan and execution to more broadly publicize analytic innovation efforts to our key clients and prospects
Work directly to support clients and assist in sales efforts, expected to travel up to 30%
MS or a PhD degree in a statistics, physics, engineering, mathematics, computer science or other related analytic field with significant years of related experience
Experience will include employing neural networks, machine learning, mathematical/statistical modeling, pattern recognition, or data mining on real world problems
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
Proven experience working directly with clients attending POC meetings and giving presentations

Principal Analytic Scientist Resume Examples & Samples

Head up technical project teams and own individual high-level projects focused on key analytic deliverables and analytic innovation projects (specific to Cyber Security or AML) working effectively with cross functional teams (i.e. Pre-sales, Product Management, Development) meeting project road maps and delivery timelines
Rapidly develop new analytic modeling projects, and be able to present them to clients in a compelling way, demonstrating value and differentiation
Shepherd scientists through project work assignments and assist in developing career opportunities for them
Hands-on analysis and understanding 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 supporting models in production, expected to travel up to 30%
Present findings to high level management both externally and internally ensuring high level of customer support
MS or a PhD degree in a statistics, physics, engineering, mathematics, computer science or other related analytic field with significant years of experience in predictive modeling with Software Development experience in either C, C++ or Java
Industry and academic experience will include employing neural networks, machine learning, mathematical/statistical modeling, pattern recognition, or data mining on real world problems
Prior experience driving high quality/on-time model development projects and driving innovation into the modeling process/offerings
Experience leading cross functional teams of data scientists, software engineers, IT and product managers in execution of an analytic research or development project (People management experience a plus)

Scientist Principal Resume Examples & Samples

Leading the activities of technical personnel; making decisions and satisfying the needs of a research program
Works independently once assignments or responsibilities are outlined and delegated
Effective in oral and written communications at all levels and cross functionally
Coordinating and reviewing the work of assigned department personnel
Coordinating and leading multifunctional teams to ensure successful execution of projects
Innovative, realistic and practical approach to responsibilities, projects, and challenges while being results oriented
Driving for continuous process improvement
Strong interpersonal skills and maintaining cooperative working relationships with others
Ensuring compliance with all Company policies and procedures, including safety rules and regulations

Scientist Principal Resume Examples & Samples

May supervise, coordinate, prioritize and lead the daily activities of a group of intra- and inter-departmental team members, including Analytical Scientists, and schedules their work load
Coordinates and executes assigned projects and activities; 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
Designs experimental plans, researches and critically analyzes data, statistical and research information gathered in support of project directives. 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
Maintains appropriate documentation of records, report sheets and laboratory notebooks as required by SOPs and FDA
Ensures the cleanliness, calibration and maintenance of laboratory equipment and work areas to ensure compliance with SOPs, GLPs and cGMPs
Reviews, evaluates and modifies test methods and procedures, as needed
May oversee 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 formal and information training to research staff on technical subjects, administrative procedures, and regulatory requirements
FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines
Advanced Chemistry, pharmaceutical and statistical theories, methods and procedures
Pharmaceutical testing laboratory programs and systems
Principles of mathematical and statistical computations
Analyzing problems, identifying alternative solutions, and implementing recommendations for resolution of problems
Leading, coordinating and reviewing the work of assigned team members
Directing the activities of technical personnel; making decisions, and satisfying the needs of a research program

Principal Medical Writing Scientist Resume Examples & Samples

Bachelor’s degree with a minimum of 7 years of relevant medical writing experience is required OR a Master degree or equivalent advanced degree with a minimum of 6 years relevant medical writing experience is required OR a PhD or equivalent with a minimum of 5 years of relevant medical writing experience is required
Experience in writing clinical regulatory submission documents, such as Clinical Study Reports, Investigator’s Brochures, Clinical Study Protocols, CTD Summary Documents (i.e., Efficacy and Safety Summaries, Clinical Overviews, etc.), Responses to Regulatory Questions, Briefing Documents, and safety documents (e.g. Risk Management Plans, etc.) is required
A working knowledge of study design and biostatistics is preferred
Immunology therapeutic area experience is preferred
This position will be located in Springhouse, PA and will require up to 10% domestic travelMedical Writing

Assoc Principal Scientist Resume Examples & Samples

The Associate Principal Scientist will report to the Director of In Vivo Investigative Safety Pharmacology or the Director of In Vivo Exploratory Safety Pharmacology
This scientist will demonstrate critical problem-solving skills, ability to analyze and interpret complex data sets and when required, integrate findings across multiple studies or projects to propose new model development, strategic planning of additional early de-risking and/or safety pharmacology studies for NBEs or NCEs
Primary objectives include: i) contribution to the conduct of investigative non-GLP lead optimization pharmacology studies and GLP safety exploratory pharmacology studies designed to provide critical information on major organ systems ii) model development, including refinement of existing approaches and/or implementation of new methods and physiologic endpoints iii) ability to integrate preclinical in vivo functional assessments into a broader interpretation of systemic risk that will require familiarity with ICH S7a & S7b guidelines (Tier 1) and ancillary safety pharmacology (Tier 2); iv) provide a mechanistic understanding of the observed profile
The Associate Principal Scientist is expected to work independently and collaborate as part of, or leading, a cross functional team. S
Uccessful interaction with co-workers within the SEP department and other groups within Merck to contribute to the functional and strategic effort of specific programs is required
In this role, an extensive understanding of in vivo study execution of complex invasive and non-invasive preclinical methodologies, approaches and models in at least one of the following areas is required: cardiovascular, renal, respiratory, neural, ocular. Experience with ex vivo preparations is a plus
Previous experience with the conduct of studies in a GLP environment is a plus
A willingness to be able to rapidly acquire such training within the SEP department to serve as Contributing Scientist, Principal Investigator and/or as Study Director on any GLP studies and/or as Study Monitor on outsourced studies is required
Possibility to participate in national and/or international professional societies, technical associations and/or standards committees (ex: HESI-ILSI/FDA working groups and consortia)
Presentation(s) of original work at internal Merck & Co. scientific meetings/events and at external national and international scientific meetings, including contribution to preparation and authorship of scientific publication(s) in peer-reviewed journals is required
Proven ability to develop and conduct complex, integrated in vivo studies in conscious rodents and non-rodent laboratory species targeting endpoints in the cardiovascular, respiratory, renal, and/or nervous systems
Significant data acquisition and analysis skills for cardiovascular, respiratory, renal, and/or nervous system endpoints

Principal Application & Data Scientist Resume Examples & Samples

Technical subject matter expertise in OSS and Microsoft technologies to build code and other technical content to support developer events, architecture design sessions, and resolve issues
Working closely with Microsoft teams to influence the future product roadmap
Developing and driving new ways of thinking across groups within the division to improve quality, engineering productivity, and responsiveness to feedback and changing priorities

Clinical Affairs Principal Scientist Resume Examples & Samples

Regulatory Report Writing
Protocol Writing Experience
Medical Device Experience
Strong ability to work with and analyze clinical data
Strong Project Management Experience
Strong Medical Writing Experience

Principal Pharmacometric Scientist Resume Examples & Samples

Consulting support for pharmacometric input for preclinical projects upon request from Takeda preclinical research group
Ph.D. or equivalent higher degree + 5 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience
PharmD +7 years of clinical pharmacology, pharmacokinetic, or other relevant experience
Masters +10 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience
B.S. + 15 years of clinical pharmacology, pharmacokinetic, other relevant experience
Educational degree in a relevant scientific area, e.g., Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmacodynamics, Drug Metabolism, Pharmacy, Bioengineering, Mathematics, etc
Strong drug development experience from a clinical pharmacology perspective
Expert knowledge of phramcometrics, pharmacokinetics and pharmacodynamics, including PK-PD data analysis techniques as well as interpretation of complex data and statistical analyses
Familiarity and working knowledge of scripting with R language is highly desirable
Must have scientific and technical expertise as evidenced by publications, awards/honors and credibility at professional societies. Alternatively, must have evidence of successful utilization of scientific and technical principles in negotiation of project goals with internal management and/or regulatory agencies
Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, bioanalytical chemistry, and pharmaceutical science
Good understanding of drug development and global regulatory requirements
Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents

Data Scientist Principal Resume Examples & Samples

Test Engineering
Software Engineering Management
Analyze data using mathematical/statistical methods
Analyze problems to determine technical solutions
Identify new and existing products, technologies, and/or architectures to solve design, development, and operational problems

Principal Scientist Downstream Bioprocessing Resume Examples & Samples

Scientific leadership and ability to work and act throughout the BioProcess organization
Act as scientific mentor for R&D personnel
Generate ideas and patents and facilitate ideas and patents from others
Drive development of new high value consumables for Bioprocess protein purification
Represent the department in the work to build the longterm strategy, working closely with Marketing and Product marketing to provide scientific, technical and business input
Actively work to identify and promote new business opportunities for Life Science based on market trends and technology developments
Secure cross functional and global innovation and technology coordination within the organization
At least very strong years of experience
Structured and
PhD in Biotechnology or

Principal Scientist, Investigative Toxicology Resume Examples & Samples

Design, conduct, and manage individuals conducting in vitro and in vivo toxicology experiments focused on identification of mechanistic basis of toxicity including the following capacities
Advanced knowledge of general, cellular, and molecular toxicology principles
Experience conducting mechanistic investigative studies involving signal transduction pathways, proteomics, and genomics
Familiarity with in vivo toxicology study design and conduct. Demonstrated knowledge, skills and publication record in investigative toxicology in drug development
Strong written and verbal communication skills and computer proficiency are required

Principal Scientist, Analytics Resume Examples & Samples

Analytics support for Process R&D and Formulation R&D
Management analytical development team & external partnership
Represent as key contact person with global analytical function to coordinate for related activities. Represent as analytics to actively participate relevant internal and external symposia/conferences for knowledge sharing and scientific level improvement
As a key member of CMC management team, contributes to department development and people development
Be responsible for drafting, reviewing, and implementing of analytical related SOPs or guidelines, as well as maintaining & troubleshooting of all formulation related analytical instruments. Be responsible and ensure the safety of Analytics labs comply with Roche SHE policy

Principal Scientist Cardio Resume Examples & Samples

In this role you will be expected to promote and facilitate creative thinking from target identification/validation through lead optimization and preclinical support of clinical programs. An important aspect will be helping to drive innovative translational strategies from preclinical in vitro and/or in vivo models to human clinical research
You will be expected to be a “drug creator”, and promote such thinking within the team and, by influence, your colleagues in other disciplines with whom you will work closely
We are therefore seeking an individual with the ability to balance internal cross-site activities with an expansive program of collaborative research with leading laboratories in the external scientific community to drive innovation and a deeper understanding of human biology resulting in the discovery of novel targets in CMD
In this position you will be responsible for contributing to CMD area strategy in collaboration with senior management and play a lead scientist role on Scientific Review and Licensing committees
Provide program leadership
Maintain high visibility among internal and external peers
Participate in hiring outstanding scientists in the CMD area
In addition, you will participate in the leadership forums at the local site with other functional leaders. Here, since this is a new site, it will be important that you help to shape the culture beyond the science
A minimum of 5 years of post-doctoral experience
Ability to present a clear and compelling scientific case
Experience in biologics drug discovery would be an asset

Principal Scientist, Dmpk Disposition Resume Examples & Samples

Drug and combination therapeutic concepts and dose predictions for the design and conduct of preclinical efficacy and nonclinical safety studies in support of FIH clinical study design and dose projections
Application of systems pharmacology principles in order to establish and build predictive preclinical frameworks with application in various therapeutic areas
Mechanistic approaches (and in an integrated fashion) for integration of key properties such as-- target expression, gene profiles, signaling and pathways, construct properties, disease considerations-- for establishing exposure-response relationships in relevant preclinical studies and assisting in projection of doses in early human clinical studies in support of IND submissions
To lead, and manage the DMPK group in Boston
To represent the function at the project teams, and collaborate directly and closely with other members of the team and Merck Network
The successful candidate will apply her / his broad knowledge in drug development to engage current and future stakeholders and customers, in particular in the early Discovery space as related to systems and integrated pharmacology strategies, into project activities and to establish critical connections to the Merck network
The successful applicant has a strong scientific interest in drug development in the Discovery and Early Development space combined with a desire to apply her/his excellent communication and interpersonal skill in all aspects of customer and team engagement
Seven to ten years of combined industry and/or postdoctoral (or fellowship) experience in relevant field with strong focus on application of quantitative sciences in drug development
Strong experience in application of quantitative sciences in drug development
Experience with MATLAB, NONMEM, SAS, S-Plus/R, SAAM, ADAPT and/or other modeling/simulation program is required
Strong communication and writing skills with ability to independently function in a highly team-oriented environment
Biotechnology or pharmaceutical experience with protein therapeutics is a plus

Principal Scientist, Protein Analytics Resume Examples & Samples

The candidate is expected to mentor and enhance his/her staff performance and to create a scientific climate of excellence within Protein Analytics
Strong scientific background in protein analysis with hands-on laboratory experience in the biochemical or biophysical characterization of proteins is required
Managing a technical team is required
Publications in peer reviewed journals and experience leading technical teams, drafting technical reports and supporting regulatory filings are required
Experience developing and qualifying analytical methods, experience with monoclonal antibodies and other protein characterization techniques are required
Excellent written and verbal communication skills and the ability to work in a cross functional environment are critical
The job candidate must be a goal oriented team player with excellent communication skills and be able to adapt to a time-line oriented work environment
Outstanding record of accomplishment in areas of protein characterization
Has demonstrated the skills that encourage independent thought and creativity in science
Has experience and demonstrated insight into the regulatory process required for drug development
Has demonstrated ability to successfully manage change initiatives
Must have the ability and strong desire to "make things happen". Must have a results-oriented work ethic and a positive, can-do attitude

Principal Scientist Bioanalysis Resume Examples & Samples

Development, validation and the conduct of assays to support biologics programs related to pharmacokinetics, anti-drug antibodies and neutralizing antibody assessments
Manage bioanalytical portion of Celgene non-clinical and clinical studies for biologics conducted at contract research organizations (CROs)
Oversee Reagent development to support bioanalytical programs (antibodies for assays, cell lines to support NAB analysis)
Compile and interpret bioanalytical data, author and review protocols, reports and regulatory dossier
Represent DMPK function on cross-functional biotherapeutics discovery and/or development teams
Evaluate new technologies for analysis of large molecules and implement for Celgene programs
Ph.D. in biological sciences or related discipline with >8 years experience
Experience in method development/validation on multiple platforms for biologics
Detailed knowledge of wide range of biologically based bioanalytical techniques including MSD, Gyros, ELISA, cell based assays and Biacore
Extensive PK/ADA/Nab assay problem solving and analytical skills; ability to resolve technical issues during method development, assay validation and sample analysis
Understanding of the scientific/regulatory standards for method validation, quality control, etc with regard to the generation of bioanalytical data, use of data management & reporting software
Proven track record of performing large molecule bioanalytical sample analysis, and performing bioanalytical method validation in a GLP environment
Prior experience in representing functional area in cross-functional product teams
Proven record of peer-reviewed publications in the relevant technical areas

Principal Scientist, Biostatistics Resume Examples & Samples

Work with the development teams to design and analyze DOE’s during feasibility and early development phases
Working with the development teams to set key quality control specifications
Developing the statistical design for all verification studies, including the documentation to support the experimental designs
Be the key liaison with the FDA during all pre-submission and post-submission interactions
Work with the CRO’s and pharma partners to develop the Statistical Analysis Plans for all clinical trials
Previous experience with diagnostic (IVD) product development is a must
Must have a demonstrated track record in direct program involvement on projects that led to successful CE-IVD registration, 510(k) clearances, and PMA approvals; direct experience and strong understanding of design control
Must have a clear sense of ownership and commitment on the projects assigned; must have a can-do attitude, and is willing to drive, and capable of driving, the assigned projects at both the strategic level (overall vision and strategies) and the execution level (be a task owner himself/herself, i.e. a “do-er”)
Basic project management skills and leadership skills are a must; ability to positively influence project teams is required
Must have a minimum of 8-10 years of diagnostic product development experience, especially in the area of IVD products
A Master’s degree or higher in a scientific, engineering, math, or biostatistics discipline is required
Excellent oral and written communication skill is required

Principal Scientist Clinical Research Resume Examples & Samples

Advances biomedical degree (terminal degree): MD, PhD, Pharm D. Must be familiar with medical conditions
Experience in clinical research and/or risk surveillance and management and/or clinical evaluation reports and/or regulatory affairs (medical devices or equivalent in pharmaceuticals) – must have experience in minimum 2 of these fields. The minimum number of combined years of experience must equal 5
Good literature evaluation skills, ability to critically evaluate medical data. Able to independently write routine technical documents, and perform independent analyses. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Proven written and verbal communication skills in a team setting and/or informal leadership role
Experience wording in a quality management system environment

Principal Scientist, Medical Writing Resume Examples & Samples

Work independently or as a part of a team to compile, write, and edit regulatory documents and reports, including clinical trial protocols, CSRs, IBs, SAE narratives, safety reports, information packages, publications, ISS, ISE, and sections of INDs, NDAs, BLAs, MAAs, Amendments, and Annual Reports across multiple therapeutic areas
Interpret clinical data, analyze published literature, define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions
Manage and direct a wide variety of client project teams involving aspects of medical writing, including identifying, directing, and delegating tasks necessary for successful regulatory document completion
Interact directly with clients and contractors; participate in and leading discussions during meetings/teleconferences
Direct, assist, and train other medical writers in the writing, editing, and compilation of documents that are components of clinical/regulatory marketing approval applications for new and approved drugs, biologics, or devices
Organize/prioritize work with limited guidance and manage projects in a timely and effective manner, work on multiple projects simultaneously, and reorganize and reschedule work as needed in order to meet client deadlines
Understand and support the nature of our business and our company’s commitment to quality and responsiveness
Ph.D., Pharm.D., M.S., R.N., or R.Ph. in a relevant scientific or pharmaceutical discipline
8 yrs (min) experience in pharmaceutical industry, with 5 yrs (min) experience in medical/regulatory writing/editing
Strong understanding of drug development, clinical study design, regulations (CFR, FDA, and ICH guidances, EU requirements), and scientific principles (e.g., experimental design). Understanding of medical terminology and statistical methodology needed
Experience writing clinical protocols, clinical study reports, and integrated summaries of safety and efficacy
Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as edit on all levels, from copy editing to major rewriting
Understanding of model documents (templates) and how to use them correctly

Principal Sterility Assurance Scientist Resume Examples & Samples

Responsible for managing and scheduling the routine sterilization validations
Writing, reviewing, approving sterilization technical protocols and reports
Works with Microsoft Project to establish and maintaining project plans
Assists with planning, scheduling of sterilization validations and dose audits
Work with the contract sterilizers with scheduling the sterilization runs, building the loads, preparing and load configurations
Serve as a subject matter expert with sterility assurance issues such as sterilization product deviations
Coordinate the testing with the contract laboratories
Reviews investigation and laboratory reports to ensure compliance to procedures and regulatory requirements and ensures product quality issues are addressed
Must be able to solve complex problems where analysis of situations or data requires an in-depth evaluation of various factors and determine direction and adequacy of designs and test results and recommends changes. Evaluates progress and results obtained, and recommends major changes to achieve overall objectives
Practices company safety and quality policies and procedures
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance

Principal Scientist Oncology Resume Examples & Samples

Supervision of diverse experimental settings in cell/molecular biology/ biochemistry: e.g. transfections, transductions, western blotting, immunoprecipitation, siRNA/shRNA, FACS, ELISA, basics in enzymology (e.g. KD, KM), cytotoxicity assays
Successful implementation and execution of innovative small and large molecule drug discovery strategies: e.g. screening funnels, PK/PD/Efficacy correlations etc
Supervise and engage junior research associate(s) and junior PhD scientists
Propose novel and actionable target ideas, aligned with internal scientific strategy and capabilities
Demonstrate the ability to manage multiple experiments/projects simultaneously
Demonstrate the ability to contribute on various projects even outside of his/her responsibility by collaborating with stakeholders from all relevant functions
Initiate and maintain external collaborations (contract research organizations, academics)
Demonstrate clear and professional verbal and written communication skills as well as excellent presentation skills
A PhD in Life Sciences or other relevant field with 6+ years industry experience is required
Deep background knowledge in cancer biology and/or cancer immunology is mandatory
Experience with antibody based and/or small molecule drug discovery is a must
Proven track record of preclinical candidate delivery is preferred
Strong track record of publications in cancer biology and/or tumor immunology is required
Experience with people management is mandatory
Experience working within and leading matrixed teams is required
Must be able to work independently and assert oneself to reach goals in a timely manner
Excellent interpersonal skills with the ability to interact effectively with people, internally and externally, is required
Detail-oriented, with excellent organizational and record-keeping skills and capability to multi-task and manage several projects simultaneously is essential
Excellent oral and written communication skills and capability to effectively present scientific data and concepts to international standards are required
Intellectually curious and well informed on the latest scientific advances in the field as well as demonstrates creativity and novel approaches to solving scientific problems is mandatory

R&D Principal Beverage Scientist Resume Examples & Samples

Lead Identification of target ingredients/technologies and validate functionality in model systems
Develop technical solutions to mitigate solubility, taste and stability concerns
Leverage experimental designs to develop robust sensory and analytical test protocols for new ingredients or components
Strong working knowledge of colloid systems, materials science, and their role in beverage taste, texture and flavor
Ingredient delivery systems and methods to stabilize ingredients across the pH range
Analytical and sensory methods to measure texture, mouthfeel, and rheology of beverages
Strong Problem Solving/Critical thinking skills
M.S degree in Chemistry or Food Science with 10+ years R&D experience in consumer products industry
Ph.D. degree in Chemistry, Biochemistry or Food Science with 5+ years in Academia or Industry
Experience working effectively as a member and contributor in
Demonstrated project management experience
Experience and track record with patents and IP strategy

Director, Principal Scientist Resume Examples & Samples

Apply master level knowledge of protein ingredients and/or protein technologies to new and novel applications and products as drive meaningful product portfolio enhancements
Serves as a technical leader and source of expert knowledge in the area of protein science to guide and advance principles, concepts and theory related to product and/or process development and participates in formulating major R&D policies, methods, procedures and operations
Identify and qualify novel formulation technologies needed to drive industry- leading innovation
Identify and share portfolio building ideas and contribute in ideation sessions
Design, develop and commercialize new product innovation and renovation
Conduct hands on bench development prototypes ensuring products meet target cost, sensory, regulatory and quality compliance as well as consumer acceptance criteria
Ensure robust formula design for successful commercialization
Partner with peers within and outside R&D in the development of product or business strategies
Connect and integrate internal and external innovation capabilities to develop product solutions, build the technology platform, and/or create new capabilities
Proactively identify and solve the most complex problems to enable the success of innovation projects or creation of new capabilities
Anticipate issues and develop product or process improvements accordingly
Challenge others to create opportunities where they see problems and demonstrate creative vision to overcome obstacles
Oversee and lead technical requirements of department level work objectives
Participate in formulating major R&D policies, methods, procedures and technical operations
Recommend vendors for product manufacturing, and works collaboratively with vendor partners to define process capabilities and manufacturing tolerances that deliver in-spec finished goods
Utilize understanding of area of expertise to act as a technical consultant on key matters to the department
Serves as a role model and mentor in advanced principles, concepts, theories and experience related to discipline
Inspire and energize employees through technical competency, personal leadership, influence, and drive for appropriate and timely results on complex projects
Identify and create network of external resources to support and assist in complex technical issues from universities, agencies, and advisory board
Identifies and conducts research and new product platforms based on interactions with marketing, insights, product science, and health & nutrition board
High level of interaction and relationships with internal stakeholders within Herbalife
Connects value, quality, and convenience with trends and science to create product platforms
High level of independence, and active seeker in application of knowledge across different product platforms
Travel as needed to commercialize new or revised formulas at the manufacturing plants
Perform other related duties as needed
Proven ability to direct technical team activities
Must have strong understanding of food/beverage/supplement formulation and have significant experience in developing and launching products
Proven track record of innovation and experience developing break-through and proprietary products
Strong technical skills and proven track record of acquiring proficiency in new technologies quickly
Strong collaboration skills and experience partnering with other functions to deliver results
Ability to effectively communicate complex ideas to a variety of stakeholders across functions
Ability to manage multiple projects simultaneously and to thrive in a fast-pace environment
Strong customer and results orientation
Relationship building, and communicator within organization
Must be passionate and driven, yet flexible and willing to embrace changing business priorities
15 or more years experience in food/beverage/supplement product development
Utilizes understanding of area of expertise to act as an authority on key matters to the company
Ability to recommend outcomes on significant and unique issues where analysis of situations or data requires in-depth evaluation of variable factors
Strong participation in formulating major departmental policies, methods, procedures and technical operations practices
Inspires and energizes all department employees through expert technical knowledge and timely results
20 years of experience in Beverage/Food/Supplement Product Development
Ability to implement technical solutions to multivariate problems
Ph.D. degree in Biological Science or affiliated fields

Principal Scientist Technology Assessmmnt Resume Examples & Samples

Generates innovative ideas or road map to apply advanced technology, process, operational efficiency or commercial application for a technical area, selected product families or key project(s) at Baxter
Leverages specialized knowledge of technology/engineering/process domains, user needs, hazards, risk, & business targets (e.g., cost) to drive product design realization, provides effective solutions to complex technical challenges
Leads by example and through demonstrated hands-on participation with teams; not a consultant; accountable for direct production of highly critical technical deliverable(s) in project(s) when serving as a Tech Lead or when partnering with the project Technical Lead to help the core team driving through significant challenges
Provides technical due diligence for technology assessment and landscape within his/her expertise area(s)
Contributes to build Baxter core technical competencies. Mentors and develops technical talent for the future
1)Masters degree with 20+ years experience or 12+ years experience with PhD
2)Has record of additional training and accumulation of expertise post Ph.D., Master, Bachelor or equivalent
3)Has demonstrable achievements (e.g. major products, processes, techniques developed, manufactured, and sold) in the field
4)Demonstrates knowledge of regulatory, quality, and business significance to technical and scientific aspects for medical products
5)Quickly zeros in on critical few actions and is able to set aside lower priorities

Principal Clinical Data Scientist Resume Examples & Samples

Clinical trial experience in early drug development
Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)
Understanding of the tools of the trade, such as data standards (CDISC SDTM), data visualisations and clinical data capture
Pharma, CRO and/or ARO experience. Demonstrates expertise in the identification, evaluation and selection of key global preferred provider partnerships. Ensures final contracts meet all technical and performance requirements for the appropriate business level, (asset, project or study)
Business acumen by understanding the implications of decisions from a business perspective and uses this knowledge to plan, implement and manage R&D, issues, projects and processes are aligned with business needs
Understanding of local regulatory environment and commercial needs at a country level
Knowledge of disease area. Demonstrates a current, in-depth understanding of the relevant medicine and associated therapy area. Demonstrates scientific principles, practices and procedures to the clinical development process, knowing when and how to balance scientific and commercial interests to ensure optimum conditions for success
Demonstrates the project management disciplines of planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics
Single point of accountability for data management deliverables at an assigned level (asset, project or study) within a given clinical development program
Global clinical project level contribution, as a Data Quality Leader, Operations and Science Leader or in close collaboration with these roles and the study team. Includes working with representatives from Data Stewardship Operations and Standards
Global internal and external expert for more complex data management and data quality considerations. May be recognized as a global technical/business leader. Regularly provides expertise to others within and outside GSK
Expert input to protocol and other plans at the development phase of a study
Expert input to the strategic delivery plan for data capture tools across the studies of a clinical development program
Expert input to the Study Data Quality Plan throughout the lifecycle of the study
Expert input to the development of data capture tools for a clinical study, including the eCRF and ePRO
Development and management of study validation and integration plans, including the validation plan, dataset definition and external data sources
Ensures data is of the quality and integrity from source through to submission, publication and archiving
Expert input to Asset Strategy and Clinical Data Stewardship
Lead role in developing strategic partnerships
Participates in due diligence activities and risk assessments with specific emphasis on the data management and data quality aspects for new acquisitions, in-licensing agreements and new partner relationships
Lead role in the management of the data vendor deliverables and performance
Subject Matter Expert for the Data Quality Community in a specified area(s) of functional expertise, which can include expert input to the development, implementation and communication of control documents
Coach and mentor within the Practices Community

Principal Scientist, Protein Therapeutics Resume Examples & Samples

Protein design and engineering
In-depth understanding of protein structure-function, with knowledge in modeling
Bacterial and mammalian protein expression (including transient transfection)
Protein purification (experience with AKTA FPLC purification systems required, HPLC/UPLC a strong plus)
Protein characterization techniques, including chromatography, label-free technologies (e.g. Biacore or Octet), and mass spectrometry
Other analytical techniques including SDS-PAGE, flow cytometry and immunoassays (ELISA and/or MSD) analysis
Experience in standard molecular and cell biology techniques (bacterial and mammalian cell culture)
Assay development and execution (in vitro, cell-based, ex vivo) with expertise in multiple assay formats (e.g. fluorescence, luminescence, FRET, FP, high content imaging)
Highly effective written and verbal communication skills
Ability to rapidly identify, learn and apply techniques
Ability to independently drive projects
Ability to multi-task, and independently design, execute experiments
Scientific creativity
Flexibility to learn and take on new tasks according to changes in priority
Strong interdisciplinary communication skills
PhD in a relevant scientific discipline (cell biology, biochemistry, biophysics or related discipline) with > 5 years experience in the biotechnology/pharmaceutical industry setting required

Principal Pharmacometrics Scientist Resume Examples & Samples

2+ years modeling related activity relevant to the role as a pharmacometrician
Strong working knowledge / experience with SAS/ R/ Splus MATLAB / NONMEM / Monolix or any other business or research analytic software relevant to pharmacometrics
Good interpersonal and communication skills bridging scientific and business needs
Good scientific leadership skills demonstrated in facilitating the inclusion and execution of pharmacometrics methods
Good team player skills to enable and participate in the contribution of quantitative teams

Senior Principal Pharmacometrics Scientist Resume Examples & Samples

Represent the GPT/GCT/CTT (or equivalent) internally and externally as the pharmacometrics
2+ years in applying model based methods in pre-clinical and clinical drug development
Contributes to external white-papers/policy shaping best practice in pharmacometrics. Has established track record of developing/establishing pharmacometrics excellence. Experience in contributing to scientific improvement/change initiatives
Good interpersonal and communication skills (verbal and writing) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence
Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development
Scientific skills demonstrated in facilitating the (pre/early/full-) clinical development strategy
Clinical, pharmacological and therapeutic knowledge of at least one disease area
Strong skills to facilitate and enable the contribution of quantitative teams

Principal Scientist Level Resume Examples & Samples

Ph. D in chemical synthesis with experience in total synthesis of natural products or in methodology development
8+ years of relevant experience in medicinal chemistry and drug discovery
Experiences in structure guided drug discovery and leading projects to development candidate selection are essential
Ability to focus on key issues and on delivering results
A proven track record of productivity
Effective verbal and written communication and cross-functional communication skills
Amgen employees are required to adhere to all corporate and local guidelines and regulations related to compliance and health and safety

Principal Scientist Biostatistician Resume Examples & Samples

Serves as a statistical lead in project teams
Develops, coordinates, and provides biostatistical leadership and support for related drug projects in Late Development Statistics
Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug projects
May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants
The incumbent will work to support the oncology therapeutic area
Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out
Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements
Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses
Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Merck Management, regulatory agencies, or individual investigators
Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators
May represent biostatistics in regulatory interactions including presentation at advisory committee meetings
Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies
Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies
Mentors and guides junior staff in functional activities
Solid knowledge of statistical and data processing software e.g. SAS and/or R
Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V
Able to function effectively in a team environment
Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development
Publications in peer reviewed statistical/medical journals

Principal Scientist, Parenteral Dosage Forms Resume Examples & Samples

Supports and guides team(s) with strategic input and strong scientific rationale on formulation & process development and quality awareness
Fosters strong team spirit and promotes knowledge exchange within and between teams
Represents line function as required in scientific forums
Understands and proactively manages the interactions of project-related activities between the own function and other departments
Supports implementation of a sound formulation & process strategy including contingency planning and risk assessments as appropriate in line with the overall project strategy and acts as a scientific expert for special delivery systems
Excellent knowledge of formulation and process development of parenteral dosage forms
Excellent knowledge of laboratory and/or technical tools
Proficient in utilization of special tools/equipment, lab automation tools and specialized facilities (sterile labs)
Good knowledge of software and computer tools
Profound knowledge of special delivery systems is desirable

Principal Scientist Cvmd Resume Examples & Samples

Expert scientific knowledge of T2D, obesity, CKD, heart failure and/or NASH
Conducts, plans and leads one or more highly complex scientific projects, including determining objectives, organizing activities and strategic direction
An emerging leader as evidenced by internal consulting, mentoring and project team membership and active support
Decisions or recommendations consistently result in achievement of significant project objectives
Through collaboration with management, expands business opportunities for the company and development opportunities for scientists
Experience in pharmaceutical/biopharmaceutical industries and excellent publication record
Outstanding team leadership skills

Principal Medical Writing Scientist Resume Examples & Samples

Bachelor’s degree with a minimum of 7 years of relevant medical writing experience is required OR a Master’s degree or equivalent advanced degree with a minimum of 6 years relevant medical writing experience is required OR a PhD or equivalent with a minimum of 5 years of relevant medical writing experience is required
Experience in writing clinical regulatory submission documents, such as Clinical Study Reports, Investigator’s Brochures, Clinical Study Protocols, CTD Summary Documents (i.e., Efficacy and Safety Summaries, Clinical Overviews, etc.), Responses to Regulatory Questions, Briefing Documents, and safety documents such as Risk Management Plans, etc. is required
Experience with CTD Summary Documents is preferred
Experience working on cross-functional teams is required
Experience with project management tools and methodologies is preferred
Neuroscience therapeutic area experience is preferred
This position will be located in Titusville, NJ, Spring House, PA, Raritan, NJ, Fremont, CA, High Wycombe, UK, or Beerse, Belgium and will require up to 10% domestic and/or international travelMedical Writing

Principal Scientist, Cellular Assay Resume Examples & Samples

Identify cell-based assays needed for pain drug discovery programs
Lead cell-based assay development and implementation
Lead cell based assay outsourcing where required
Report data and strategy in written and verbal communications to projects teams and senior management
Over 7 years pharmaceutical / biotechnology industry experience is essential
Strong technical expertise and quantitative skills in biochemical and cell-based assay development and screening to support all phases and aspects of small molecule drug discovery programs
Demonstrated leadership capabilities to develop a strategy to support drug discovery programs
Strong collaborative skills in working with internal and external scientific and technology groups across different disciplines
Effective communicator of ideas, project goals and data to team members across cross-functional roles/disciplines

Principal QA Scientist Resume Examples & Samples

Responsible for the review and approval of relevant validation and change control programs
Responsible for the review and approval of a wide range of PD procedural and technical documentation for compliance with relevant GxP regulations
Responsible for identifying and investigating unplanned quality events and providing direction, recommendations and final approval for the optimal course of action to ensure both a timely closure and adherence to relevant GxP policies procedures and regulations
Responsible for providing support, when necessary, to the RDQ GMP audit group at Moreton when assessing the suitability of current and potential third party contractors and vendors
Responsible for the review and approval of batch documentation generated by a third party contractor in accordance with GxP
Responsible for interpreting policies, procedures and industry quality regulations and adapting them to quality systems at Moreton
Responsible for representing Moreton in the development of global procedures and projects and providing deliverables inline with project completion and production schedules
Responsible for coordinating and implementing GxP training programs at Moreton
If in a supervisory role, determines and coordinates the assignment of tasks to be carried out by the assigned Senior QA Scientists. Supervises the review and approval of GMP records, data, and other release documentation as needed, intended for the manufacture of investigational medicinal products
Minimum BSc (Hons) in related science field
Minimum of seven years of experience within a GxP environment
Experience in dealing with regulatory agencies
Strong knowledge of pharmaceutical development process
In-depth knowledge of GxP regulations
Strong interpersonal and communication skills and solid report writing ability
Computer literacy (Microsoft Office and SAP environment)
Speed
Passion
Accountability

Principal Clinical Data Scientist Resume Examples & Samples

Bachelors degree with minimum 3 years experience OR equivalent experience in lieu of a Bachelors degree with at least 7 years experience
Understanding of the tools of the trade, such as data standards (CDISC SDTM), data visualizations and clinical data capture
Expert input to the Study Data Quality Plan throughout the life cycle of the study
Development and management of study validation and integration plans, including the validation plan, data set definition and external data sources

Data Scientist Principal Director Resume Examples & Samples

Develop a strategy for as a service pricing that aligns to Accenture Operations’ overall market strategy
Successfully conceptualize, develop, and implement value based pricing models, tools, and methods
Integrate incremental and final outcomes into relevant business processes
Build the service pricing organization
Execute change management strategy with internal and external stakeholders to achieve a value based mindset
Engage in significant market pursuits
Collaborate with key stakeholders; Competitive Intelligence, Corporate Development & Transaction Services, Analytics, Technology, Sales, etc
Minimum of a Masters degree in Statistics, Mathematics, Computer Science, Economics or related scientific disciples
Minimum 12 years of Data Science experience to include working with advanced analytical models
Minimum 10 years in a leadership role
Practitioner with a PhD in Statistics, Mathematics, Computer science, Economics and related scientific disciples
Subject matter expertise related to services pricing and advanced analytical models
Leadership experience with a global matrixed team and ability to collaborate, influence, and build a highly qualified team
Proficiency in statistical and other tools/languages - R, S-plus, SAS, STATA, Python
Experience working with large data sets and tools like MapReduce, Hadoop, Hive a plus
Proven background in at least one of the following - Reliability models, Markov Models
Stochastic models, Bayesian Modeling, Classification Models, Cluster Analysis, Neural Network, Non-parametric Methods, Multivariate Statistics

Principal Scientist, Data Science, Sequencing Resume Examples & Samples

Primary data analysis algorithm engineering
Collaborating with scientists from a diverse set of fields to advance system characterization (statistical) tools
MUST have scientific programming experience in Python, especially numpy / pandas / scikitlearn / matplotlib or the equivalent, such as Matlab and C/C++ experience and willingness to learn Python
MUST have a firm grasp of concepts from probability theory / signal processing
MUST have some experience with advanced statistical methods (clustering, Markov models, neural networks, regression analysis, principal component analysis)
MUST be excited about expanding your current skill set. If a new tool or methodology is needed, you will have the flexibility to spend time learning about it and apply it to the project
A basic understanding of analog electronic circuits is a plus
Experience with distributed computing or cloud implementation is a plus
Previous exposure to fields of bioinformatics, natural language processing, or similar is a plus

Principal Scientist Vitamin E Resume Examples & Samples

Play a key role in shaping and advancing a pipeline of innovation projects. Projects span the range from product and process development for novel food ingredients to process optimization for existing manufacturing assets
Bachelors Degree in Chemistry, Food Science, or related technical discipline that includes experimental skills
10 years of experience in process and product development, with at least 5 years of this experience in the technical field of lipid based ingredients
3 years of project management experience for new product development
Demonstrated track record of leading complex innovation projects involving cross functional teams and spanning the full life cycle from ideation through to commercialization
Demonstrated understanding of chemical processes at the molecular level
Demonstrated knowledge of lipid chemistry
PhD is preferred in the area of Organic Chemistry, Polymer Chemistry, Food Technology or similar technical discipline
3+ years of experience in the technical field of Mixed Tocopherols, Vitamin E, Phytosterols, Fatty Acids or lipid ingredients (can be years of experience gained through academic research or in a work setting)
Experience working in a food production environment
Familiarity with regulatory codes (Code of Federal Regulations, Food Codex Standards)
Experience with intellectual property (patent reviews and patent drafting)
Experience giving technical presentations to customers, industry trade shows and conferences

Data Scientist Principal Director Resume Examples & Samples

Bachelor’s degree in Statistics, Mathematics, Computer science, Economics, Analytics or related scientific disciplines
Minimum 16 years' of Data Science experience
PhD in Statistics, Mathematics, Computer science, Economics or related scientific disciples
Experience in any of the domains: Retail, Digital Marketing, eCommerce, Health, Supply Chain, Banking

Principal R&D Scientist Resume Examples & Samples

Directing a team of 8-15 highly skilled engineers supporting the development of next-generation metal coatings and eventual commercialization of advanced Ni electroplating technology, chrome and/or thermal spray technologies
Day to day technical leadership of the global team in New Jersey, Arizona and China. Ideal candidate will be capable of managing direct reports, although she/he may not have this responsibility initially
This role will be based in Morristown, New Jersey, USA
Define & drive technical strategy, including assessment of next best alternatives and risk management
Lead the transfer of technology from lab to pilot and production scales
Contribute to the technical portion of business plan development
Support the Program Manager in the effective execution of a yearly budget in excess of $1M. Also plan and communicate capital equipment needs
Collaborate with the Marketing & Product Management Director, Chief Engineer, Engineering Fellow and Advanced Technology Engineers in defining the integrated product and technology road map for advanced Ni electroplating technologies
Synchronize product strategies and technology readiness level (TRL plans) to milestone dates
Identify risks early. Aggressively manage and execute mitigation plans, and develop swift and effective corrective action plans when risks are realized
Communicate technical progress, status, metrics, and gap closure plan to the Program Manager and management up to Vice President level
Quickly resolve issues across functions and disciplines, and is expected to develop relationships with all required Functions to ensure optimal product development efficiencies within the organization
Bachelor of Science degree in Materials Science, Mechanical or Aerospace Engineering, or equivalent technical degrees
10 years of on hands electroplating experience
Must be a US Citizen due to contractual requirements
Advance degree a plus experience in leading and / or managing teams of engineers
Strong R&D background and track record of new electroplating chemistry/technology for commercial applications
Electroplating industry experience
Proven technical leader (patents, publications, etc.)
Technical experience with expanding roles of leadership and accountability
Successful candidate needs to have the ability to lead a highly technical team and work effectively with other organizations and individuals at all levels
He/she is highly intelligent and enthusiastic with a commitment to excellence
Hands-on person who possesses the sense of urgency and drive to achieve results
Experience in advanced materials research and development a plus
Solid background in Project Engineering and Project Management
Project Management Professional (PMP) credential a plus but not required
Track record of meeting technical, schedule and budget commitments while satisfying internal and external customers
Action-oriented, self-starting approach with ability to decompose overall goals into detailed action plans
Strong problem solving sills
Experience leading and influencing at multiple levels within an organization
Self-motivated, empowered, team leader with proven track record of working effectively across geographic and cultural boundaries
Leadership, interpersonal, presentation, written and oral communication skills
Able to positively influence others, and resolve conflicts quickly and tactfully

Data Scientist Principal Director Resume Examples & Samples

Sales Origination & Business Development
Accountability for analytics sales targets at an account/portfolio of accounts
Position Accenture as the lead partner for Analytics with our clients
Identify new business opportunities relating to analytics or digital initiatives
Lead the development of businesses cases for further project sales as determined by the practice
Facilitate the development of “request for proposals” responses and contract development
Analytics Transformation Mobilization and Project Advisor
Drive the client stakeholder engagement plan to scope the overarching opportunity
Work closely with leadership to set strategy and define success criteria for any project
Actively structure and drive the executive governance process with the client (VP and above)
Drive the integrated value proposition and work with the client to gain alignment and buy-in
Apply Accenture standard methods for performing strategy assessments and implementations
Leverage the best from Accenture to architect the solution and shape the commercial proposition
Practice & Offering Management
Define and articulate how best to tailor analytics offerings to meet market demand
Play an active role building a practice including capability development and recruiting
Identify and help bring into the practice talented individuals both internally and externally
Ability to build and manage a practice
Experience developing and auctioning business plans
Ability to originate sales and develop commercial constructs
Understanding of how to link analytics with business value to shape the business case
Understanding of analytics operating models and governance structures
Deep understanding of analytics, including data management, business intelligence, and predictive analytics
Understanding of how advanced data techniques can be applied to solve client problems
Knowledge of big data platforms, tools and applications
Quantitative background/proven problem-solving skills
Understanding of analytics roles and responsibilities (e.g., data scientist)
Functional analytics experience
Ability to partner with our clients to understand business problems and strategies
Ability to translate business issues into specific requirements to develop analytics solutions
Client Delivery & Relationship Management
Ability to interact with and influence VP and above
Ability to interpret the results of analytical insights and translate results to the client in business context to drive value
Able to explain complex concepts in non-technical language
Strong story-telling ability
Minimum of 10 years Programming experience such as C++, Python in Linux environment
Minimum of 10 years working in analytics or related business transformation
Minimum of 10 years in strategy or management consulting
Masters of Science either in Computer Science or Engineering
Cloud knowledge such as AWS, GCP and/or Azure etc
Understanding of value based constructs
Ability to understand and apply statistical methods and outputs to create client value in a business context
Experience with evolving approaches and technologies such as Big Data, Artificial Intelligence, Machine Learning, Cognitive Systems, and Robotics
Excellent communication (written and oral) and interpersonal skills

Scientist Principal R&D Resume Examples & Samples

Minimum 10 years of directly related experience with optical systems, electro-optics, laser systems, sensor electronics, and/or sensor technology
3+ years Program management experience of internal and external R&D projects including scheduling, milestone tracking, manpower planning, earned-value measurement, estimating and budgeting
Due to export control and possible security clearance requirements, the candidate must be a U.S. Citizen, or a U.S. Permanent Resident who has applied for naturalization in the last 12 months
Experience leading teams of engineers, scientists, or technicians
Experience leading, planning, and executing externally-funded proposal activities involving multiple sites and external partners
Knowledge and experience in taking optical systems through maturation from concept development to engineering to production
Knowledge and experience in developing intellectual property including patents and assessments
Experienced in leading or contributing to regulatory documentation and advisory committees
Knowledge of U.S. Federal Aviation Administration regulation and certification processes
Analytical capability to design optical systems using tools such as optical ray tracing/simulation tools
Experience and knowledge of atmospheric physics or meteorology
Willingness to travel (~25%)

Biomarker Principal Scientist Resume Examples & Samples

Helps in the delivery of high quality biomarker strategies for target engagement, pharmacodynamic endpoints and patient selection, under the supervision of other biomarkers (where appropriate)
Provides insight into novel ways to incorporate biomarkers into clinical designs to enable early understanding of emerging drug profiles
Comfortable working in a fast-paced environment where speed is paramount

Biomarkers Principal Scientist Resume Examples & Samples

Effectively engages with development teams and technical/scientific experts to define, revise and progress translational/biomarker plans
As appropriate, provides biomarker expertise to progress validated biomarkers into development of pharmacodiagnostic tools
Experienced scientist with 7+ years’ experience in the drug development process
Documented experience in hematology-oncology (Lymphoid and Myeloid leukemias, Hodgkin and non-Hodgkin Lymphomas, and/or Multiple Myeloma) is highly preferred but not indispensable
Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
Ability to recognize, articulate, and accept calculated risks to make informed decisions
Demonstrated scientific acumen and mechanistic understanding of disease biology

Formulation Principal Scientist Resume Examples & Samples

Design and conduct studies to characterize molecular and biophysical properties of peptides, proteins, monoclonal antibodies and other large molecules
Design and develop parenteral biologic formulations (liquid and lyophilized, and other dosage forms)
Design and perform commercial process development studies for drug products by using expertise/knowledge of scale-down/scale-up principles
Manufacture and supply formulations/drug product to non-pivotal and pivotal clinical studies
Coach/mentor junior staff within the group
Lead matrix CMC teams that develop ABI processes, Analytical Methods and Drug Products for registration in global markets
Keep abreast of relevant new technologies & regulatory expectations/requirements
Ensure work activities are aligned with relevant Quality, regulatory and EHS requirements
Experience/ advanced knowledge of parenteral formulations development for biologics
Advanced understanding of protein chemistry, degradation pathways, and general approaches for stabilization
Advanced knowledge of biophysical techniques and ability to apply them for characterization and problem-solving during formulations development
Ability to independently contribute from the bench

Principal Scientist Bioanalytical & Biomarker Dev Resume Examples & Samples

Responsible for researching/designing and managing a broad range of bioanalytical and biomarker method development, validation, sample testing as well as data interpretation and reporting for large molecules to support Research, Non-clinical, Clinical and Commercial Development programs for rare diseases in a variety of therapeutic indications
Recognized and advanced expertise in his/her field of training and broad knowledge of drug discovery and development with the ability to apply independent judgment and direction to design, execution, and interpretation of experiments in compliance with appropriate SOPs and global regulatory guidance
Must have demonstrated success managing multiple priorities with aggressive timelines providing technical, planning, budget and resource oversight. Manage or lead projects for multiple programs across the portfolio and schedule activities in accordance with line function and program/corporate goals/assignments and priorities. Must be highly independent and motivated with excellent oral and written communication skills
Effectively manage both internal and external work, including interactions with technical and administrative staff at CROs or external vendors to deliver high quality results in a fast-paced environment
Implement innovative approaches and propose new strategies within Research; develops new methods and extends technology to drive applied science into new application areas
Effectively communicate and interfaces with internal/external business partners, including internal Compliance and Quality Assurance Units and Regulatory functions to ensure bioanalytical methods, validations and supporting reports are in compliance with applicable GLP, GCP and CLIA and other regulatory requirements. Manage and control of documents/records for compliant operations
Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication. Review assay validation and bioanalytical reports and provide training and mentorship to internal staff
25% Research/identify/design and implement high complexity bioanalytical test methods and/or biomarker strategies
25% Manage external vendors/CROs to meeting sample testing timelines
20% Represent Bioanalytical group on various cross-functional project teams
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 communicates 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
PhD in life science and 8+ years of industry experience
Experience developing and validating GLP/GMP analytical and/or bioanalytical test methods for large molecules
Familiarity and experience with global regulatory guidelines, expectations and corresponding industry best practices is required, e.g., FDA Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP)
Experience placing and managing external work at CROs/CMOs is required

Principal Scientist, Clinical Research Resume Examples & Samples

Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans
Leverage appropriate on going data review to identify and mitigate patient safety, study design, data integrity or study conduct issues
Ensure all operational aspects support end point integrity and data validity
Influence program direction based on changing internal and external landscapes within phase, disease or therapeutic area; able to think strategically to best position a study within the current Clinical Development Plan
Prior investigator site and/or monitoring experience is advantageous
Expert level writing of complete Study Reports & Protocols
Expert level in designing clinical studies
Deep understanding of clinical development within at least 2 Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development
Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas
Ability to establish operational plans and support the CRO in the execution of the plans. Requires a balance of scientific and operational/project management and team leadership expertise
Must be able to build effective relationships across and up and down the organization
Excellent project management skills, including risk assessment and contingency planning. Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model
Able to partner with other functions and both internal and external stakeholders
Excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills
Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development
Effective leadership skills to ensure development and execution of MA medical plan

R&d-assosiate Principal Scientist Resume Examples & Samples

Provides leadership in aligning, driving and embedding new ways on ways of working for the Consumer Inspired Quality and works closely across the regions and categories to assure adherence of Consumer Inspired Quality work practices; including
Demonstrated successful leadership of project management, commercialization and influencing of multi-functional teams. Capable of managing multiple priorities
Deep understanding of commercial strategy process, product/package development process, food safety, plant commercializations, ingredient and package technology
Willingness to travel for up to 30% of time

Principal R&D Scientist Resume Examples & Samples

An expert in MDx product development who should lead NPI product design, development and troubleshooting activities in MDx R&D team
Responsible in the guidance of MDx R&D engineers at milestone stages with good scientific knowledge and technical skills, especially troubleshooting skills
To train MDx R&D engineers on product development
To understanding design control and risk management and to implement into NPI projects
To evaluate new technique and new platform for future NPI projects
Solid knowledge in technology and industrial trend in molecular diagnostics, especially qPCR and multiplexing MDx
At least 3 years industrial experiences in IVD product development, covering the complete R&D process, from product design, research and development to CFDA/CE-IVD registration
The candidate should have a PhD degree
Major in biology, including biological sciences, biotechnology, molecular biology, etc
Additional knowledge on virology, microbiology, immunology and cancer biology is a plus

Principal Applied Data Scientist Resume Examples & Samples

7+ years’ experience solving analytical problems using quantitative approaches/Machine Learning
Master's degree or PhD in quantitative field such as mathematics, statistics, or engineering/technology with an emphasis on statistical analysis; or applicable experience
Proven capability to deliver end-to-end analyses by asking the right questions, extracting data, and building predictive models to ensure actionable results
Excellent communication & interpersonal skills with an ability to communicate ideas, insights and complicated analysis effectively at all organizational levels, include engineering leadership
Proven track record of problem solving and using experiment driven approaches
Experience with large scale distributed databases and computing systems like COSMOS, Hadoop, or HDInsight
Expertise with statistical software packages like R, MatLab, NumPy, SciPy, or SAS
Experience with CPE initiatives for large scale services is desired

Principal Scientist Group Leader Resume Examples & Samples

Minimum of 8 years of relevant industry experience performing chromatographic method development/validation, GMP experience, leading investigations/critical thinking skills, previous experience in managing development projects and directing activities of others, communicate effectively/professionally with clients
Bachelor's, Master’s, or Doctorate degree in biochemistry, biology, or chemistry
BS with 8+ years, MS with 5+ years, or PhD with 3+ years in the bio/pharmaceutical industry; protein chemistry, HPLC, Mass Spectrometry

R&d-assosiate Principal Scientist Resume Examples & Samples

Support Regional CIQ Agenda according to roadmap & needs
7 years of experience in FMCG industry, including at least 2 years of experience in a plant and at least 2 years of experience in Quality. R&D experience will be a plus
Knowledge of quality requirements: QP’s and HACCP standards (preferred)
Has successfully delivered business-related results, (e.g. implementation of new technology, productivity, quality improvement or growth) by driving technical project implementation
Fluency in English; other European languages as an asset

Principal Scientist Operations Resume Examples & Samples

Perform equipment Installation, Operational, and Performance Qualifications on a variety of facility and manufacturing equipment in a full Biotech upstream/downstream manufacturing plant. Qualification includes conception of protocols, authoring protocols, execution, and final report writing
Facility equipment includes water, clean steam, clean compressed dry air, and nitrogen systems. Facility equipment also includes autoclaves, walk in controlled temperature units, environmentally controlled areas, process control systems, and building management systems
Manufacturing equipment includes a variety of lab equipment such as fermenters, HPLC’s, UPLC’s, and Spectrophotometers. Manufacturing equipment also includes label printing, and filling and packaging lines
Participate/lead project for equipment qualifications, aassume responsibility for timely completion of projects or assigned work, ensuring activities are consistent with project critical path and responding appropriately to changing priorities. Regularly communicates project status internally and externally
Assure all equipment and facility qualification activities comply with existing corporate and government standards, i.e., QSRs, cGMP, ISO 13485, OSHA, etc. Assure timely completion of deviations, non-conformance investigations, corrections, corrective actions, preventative actions, and proof of effectiveness
Train personnel executing equipment qualification with a clear focus on specific activities pertaining to protocol requirements
Conceive, author, execute, and issue final reports on computerized software systems related to equipment
Excellent verbal communication skills required. Excellent interpersonal skills required to interact with stakeholders such as system owners, quality assurance, and auditors
Excellent technical writing skills required. Studies, protocols, reports, deviations, and non-conformances must be written in a clear, structured manner directed to reviewers in an FDA regulated environment
The candidate must be a self-starter with the ability to work with minimal supervision in a fast paced environment. The candidate must have the ability to prioritize and manage multiple projects and priorities. The candidate must be a team player, willing to help others and cross train them as necessary
Candidate must be proficient in Microsoft office. Proficiency in Minitab statistical software and Trackwise is a plus

Principal Clinical Data Scientist Resume Examples & Samples

Highly effective interpersonal skills with excellent written and verbal communications appropriate to the target audience, promoting effective decision-making where necessary
Sound understanding of the regulations (including ICH GCP) and thorough knowledge of clinical data management
Highly organised with ability to prioritise work and remain focused on objectives in rapidly changing circumstances
Conversant with the clinical trial environment and bigger picture of drug‐development
Practical experience in multiple data capture tools
Demonstrated effective oversight of outsourced activities
Knowledge of central / local lab setup and management
Ability to identify and mitigate risks to data quality to maximise data evaluability
Excellent Leadership skills with the ability to work alone and in a team
Excellent Negotiating and Influencing skills, identifying win/win solutions
Consistent attention to detail, ability to deliver to demanding deadlines whilst maintaining the highest quality
Respiratory, Neuroscience, Dermatology and/or Immuno-Inflammation therapy area knowledge
Demonstrated experience leading in both matrix and line environment to deliver projects, and deliver clinical development plans
Ability to listen, objectively challenge and influence key stakeholders and decisions at all levels
Ability to cope with ambiguity and apply
Usage of SAS, some programming experience would be useful but not essential
Experience in the delivery of data for early phase clinical trials
Input into and maintain the Project Data Strategy Plans ensuring the development of new standards, vendor selection, data acquisition tools, technology solutions, processes, timelines and data quality aspects across all studies within a project
Act as a primary contact for Project Teams (core and extended), internal stakeholders and external parties
Ensure effective functional resourcing strategies (i.e. in-house, outsourced etc) and provide data management budget estimates as required
Develop asset level risk analyses, mitigation and contingency plans for assigned studies and projects
Lead the delivery of consistent solutions in the clinical trial data collection, validation, integration, extraction, and reporting of early‐phase Clinical Pharmacology (CP) studies within a project
Select, manage and perform oversight of vendors providing technical and data management services to the study and project teams
Project manage the delivery of fit‐for‐purpose data within single clinical studies and programmes of studies including in‐stream data delivery, database release and freeze activities
Be accountable for the data quality within single studies and/or programmes of studies
Lead the set up of data collection (eCRF, ePRO etc) and in-stream reporting tools for clinical studies within a Project
Provide data management input to the protocol, and translate the protocol into specifications for all data requirements and data types at a study or project level in line with reporting needs
Accountable for the development of the Data Validation Specification in collaboration with the study team and project requirements
Define and execute Data Quality and Protocol Deviation Management Plans, gaining study team input and applying project standards
To Interact with study monitors, site medical staff, and data providers on areas impacting data quality
Ensures peer review, completion, lifecycle management and archiving of all data management documents
Drives Cross-Project Data Management collaboration, sharing information and lessons learnt as a Data Management expert within the Data Management Community
Responsible for appropriate communication of data management deliverables to the study and project teams
In partnership with study team, responsible for delivery of data management contributions to regulatory submissions as required
As required, identify, participate and/or lead process improvement initiatives
Train, coach and mentor staff as required completion of specific project goals and objectives in accordance with defined quality and time based metrics

Toxicologist, Principal Scientist Resume Examples & Samples

Serve as a Principal Scientist (Toxicologist/Pharmacologist) for studies including TK/ADME/Toxicology and as a resource on animal models
Serve as primary contact for clients and represents MRIGlobal as a technical expert
Establish a course of action to accomplish a specific project or goal; plans proper assignments of personnel and appropriate allocation of resources; determines schedule of events; communicates expectations about tasks and deadlines; develops contingency plans
Work under pressure and manage multiple tasks simultaneously
Organize activities and focus on priority goals and problem areas
Responsible for writing, reviewing and following facility methods and Standard Operating Procedures
Conduct data analysis and review data for accuracy and completeness
Perform peer review of data and reports
Support new business opportunities and proposal and technical report efforts
Ph.D. in Toxicology/Pharmacology (or equivalent) plus a minimum of 10 years of relevant experience
Demonstrated experience in the following areas: pharmacokinetics, drug metabolism, pharmacodynamics methods, elucidation of metabolic/degradation reaction mechanisms, drug physiochemical properties, and drug/excipient interactions
Proficient computer skills and ability to learn new software and systems
Leadership abilities with strong problem solving aptitude
Ability to effectively communicate expectations, assess client needs, gain acceptance of an idea/plan/activity/product, and interact with technical staff at all levels in a team-based environment
Willingness to work some evenings and weekends
Proficiency with Phoenix - WinNonlin software
Experience working in ABSL-3 with a wide range of pathogens testing the efficacy of medical countermeasures for Category A biological agents
Experience working in chemical agent laboratories with a wide range of chemical agents testing the efficacy of medical countermeasures
DABT
Ph.D./DVM
DVM with animal research experience
Experience working in 21 CFR Part 58 (GLP) laboratory environments
Experience with the contract research business, federal regulations, proposal writing, project management, and instrumentation is desired

Principal Scientist Functional Genomics Resume Examples & Samples

Scientific leadership and management of a CRISPR screening project portfolio
Working closely with stakeholders in Chemical Biology and Disease Biology teams to design and execute CRISPR screens, from initial genome-scale screen through hit-conformation
Development of cell-based assays using a variety of technologies for measuring disease-relevant phenotypes
Maintaining knowledge and expertise in emerging technologies and applications for genome engineering
Written and verbal communication of study results to project teams and leadership, including proposals for further experiments to validate key findings
An understanding of human genetics and functional genomics tools used to identify disease-associated genetic variation
Experience with high-throughput genomic screening using RNAi and CRISPR
Significant experience in the supervision and mentoring of scientific researchers, and demonstrated ability to work with efficiency and diplomacy as part of a team
Demonstrated experience managing a portfolio of research projects
Extensive hands-on experience and leadership of high-throughput automated cell-based assay development using a variety of technologies for measuring disease-relevant phenotypes
Experience with NGS technology and use in the interpretation of genomic screens
Strong communication and collaboration skills, including an ability to effectively communicate experimental design, results and conclusions

Principal R&D Scientist Resume Examples & Samples

Provide technical support to manufacturing on design or process issues. Work with manufacturing counterparts to ensure manufacturability
Handle troubleshooting and problem resolutions related to assigned design and process responsibilities
Conduct research using plasma technology to enable innovation in surface science
Work closely with other departments within Boston Scientific to effectively complete projects on time
Manage activities of external engineering and cross-functional groups and/or external vendors
Work across divisions to develop a vision for how new technology is strategically integrated with other platforms that exist across the broader Company
Develop schedules, timelines and resource requirements for completion of assigned work
Give direction to scientists, engineers, technicians and drafters and clearly communicate their roles and tasks
Master’s Degree in Plasma Physics with experience in plasma processes
3+ years of experience
Candidate must have a theoretical understanding of plasma processing equipment and design
The candidate will be responsible for designing and purchasing R&D level equipment – developing processes and then understand all aspects of scaling to the manufacturing environment to ensure complete technical transfer to our manufacturing lines
PhD in Plasma Physics with experience in plasma processes

Assoc Principal Scientist Resume Examples & Samples

Provides scientific leadership and expertise in biochemistry/biophysics/ enzymology or molecular/cellular pharmacology. Implements biochemical or cellular assay development and methodologies to generate data to support molecular mechanism of action studies and hit/lead-finding activities
Under general scientific and administrative direction, carries out independent research projects within function or across functional groups to develop and execute on research operating plans, new research and technology assessment proposals to advance in vitro pharmacology. Proactively pre-empt and respond to emerging project needs to align with business and functional strategy
Contribute to and help define and implement the pharmacology research strategy aligned with MSD Research Laboratories (MRL)’s drug discovery approaches and organizational objectives and serve as a resource for technical, pharmacological, biological and drug discovery expertise
Identify, evaluate and recommend new technologies or capital investment opportunities to maximize the group efficiency, meet scientific objectives and promote MSD as a leader in the field, aligned with MRL strategy
Supervise, train and mentor junior scientists to ensure continuous performance improvement and development and assist in aspects of recruitment and scientific supervision. Assist in the management of junior scientists to develop new assays employing complicated or technically-demanding methods in biochemical/cellular pharmacology
Operate autonomously to draft research project proposals, reports, publications and other scientific communications related to research activities. Effectively develop and present a compelling case for research proposals, working collaboratively to gain support for such proposals
Promotes the use of novel experimental approaches within own area including implementation of advanced laboratory equipment, design of robust scientific experiments and routinely investigates/creates innovative processes, hypotheses and methodologies. Participate as a technical specialist in cross-discipline project teams, sharing technical and biological knowledge across disciplines
Identify, lead or support collaborative initiatives with academic research institutes to further in vitro pharmacology, lead finding and target identification or validation approaches as part of drug discovery programs
Ensure reliable documentation of experiments and results in electronic notebooks and other documents in compliance with company policies and project needs. Identify the need for and ensure the implementation of risk assessments and SOPs as appropriate
Maintain visibility, both inside and outside of functional area, leveraging literature and monitoring industry trends and developments
Proactively plan and execute own development strategy that applies technical and functional knowledge to design experiments/ projects that contribute to overall direction of function/discipline. Demonstrates MSD Leadership behaviors as good role examples
Expertise in biochemistry/biophysics or molecular/cellular pharmacology with demonstrated experience in assay development and methodologies supporting mechanism of action studies or hit/lead validation
Extensive experience in state-of-the-art technologies such as LCMS, fluorescence-based techniques, SPR, calorimetry, fluorescent- or cell-based imaging, binding or reporter assays or scintillation proximity assays with demonstrated ability to perform detailed mechanistic studies
Ability to identify, evaluate and integrate new technologies to expand assay capabilities
Demonstrated ability to develop and implement innovative ideas that yield significant programmatic/process impact
Highly collaborative yet independent scientist that excels in a matrix environment
Excellent interpersonal, collaborative and communication skills expected

Medical Affairs Principal / Senior Scientist Resume Examples & Samples

Minimum 4 years of strong, multi-discipline experience including clinical development, operations, project management or other functions in order to act decisively to manage the operational needs of the Global Medical Community with minor direction
Demonstrated business acumen
Ability to manage and influence discussions with others
Ability and eagerness to challenge status quo; make quick decisions; and lead/operate successfully in an empowered organization
Enhancing Global Medical Community Operating Model to drive results for GSK CH

Principal / Senior Search Scientist Resume Examples & Samples

Ownership on the Search Science ranking algorithm design and implementation
Develop search, recommendation, personalization on vip.com via data driven,
Ph.D. in Computer Science or related fields
3+ years of Java, or C/C++ development coding experiences is required
Hands-on experience in SQL, Hadoop/Spark, Tensorflow, Python/Hive/R
Previous experience developing search driven platforms and use cases at scale
Experience in NLP is a big plus
Experience and knowledge of distributed machine learning in large scale computing environment, unsupervised deep learning/neural networks are a must-have
Familiar with search/recommendation/classification domains
Solid data mining and machine learning expertise required
Self-motivated, strong problem solving and communication skills
Bilingual in English and Chinese is a plus

Principal Scientist Dmpk-bioanalysis Resume Examples & Samples

Responsibility for PK, ADA or BM method development
In addition he/she will represent DMPK on translational project teams to provide guidance on bioanalytical issues, ensure alignment and manage timelines
The successful candidate will lead a team of dedicated scientists responsible for developing methods for preclinical PK and ADA assessment
Developing protocols for antibody or ADC exposure measurement from various biological matrixes e.g. tumor or brain
Developing new assays for bispecifics and antibody-drug conjugates, as well as evaluating and recommending new bioanalytical platforms to accelerate bioanalysis of project from early discovery through development
The candidate is expected to lead evaluation of bioanalytical platforms to assess intactness of protein therapeutics in vitro and in vivo in various matrices
PhD in the bioanalytical field with at least 8 years of experience in the pharmaceutical industry
Experience in developing PK and ADA assays as well as biomarker methods
Experience in supervising scientists at all levels in developing and troubleshooting bioanalytical methods
Proven track record in scientific excellence, including biomarker research
Experience in supporting drug discovery and development projects, including the ability to

Principal Human Factors Scientist Resume Examples & Samples

BA / BS degree in Engineering or Life Sciences
7-10 years of overall Industry experience
Minimum of 3 to 5 years of relevant experience working in a medical device or pharmaceutical environment
Understanding of human factors usability engineering is required

Scientist Principal Technical Specialist Resume Examples & Samples

Perform Communications Systems Engineering trades addressing satellite link performance, link availability and capacity, modulation and coding schemes as well as understanding and assessing transmitter and receiver hardware performance
Communications System Architecture definition; specification of system requirements flow-down to subsystem requirements; and derivation of Concepts of Operation with associated requirements impacts
Leading/Participating in system level trade studies to identify and quantify risks, operational needs, technical requirements
Lead / support small teams of engineers performing simulation and analysis of advanced RF and/or Optical communication systems
Lead / perform technical analyses using simulation and/or analysis tools, then organize and deliver results as technical briefings and reports
Develop and execute test / readiness demonstrations. Provide technical leadership / support to proposals
Advanced technical degree (e.g. MS or PhD in Electrical Engineering)
General understanding of EVM, Bandwidth Efficient Modulation (BEM) and Forward Error Correction (FEC) encoding schemes such as DVB-S2
Detailed experience with RF hardware systems and subsystems, Detailed experience in link closure analysis for satellite and/or wireless terrestrial comm systems
Experience w/ Vencore Comm Analysis tools such as MISTICS, LINKBASE, or APT or tools with similar functions

Principal Scientist, Translational Medicine Resume Examples & Samples

MD, MD/PhD or PhD degree in a relevant scientific field (e.g. molecular biology, cell signaling, bioinformatics) or equivalent experience
Academic and/or industry experience post-MD/PhD experience
Outstanding record of innovative contributions to translational sciences in oncology as evidenced by a strong publication record including first / senior-authored publications in top-tier journals, inventorship on patents/filings and presentations at important conferences
Prior experience managing a group of research associates, scientists or leading a matrix team
Outstanding verbal and written communications skills are a must
Experience in analyzing large datasets including genomic and proteomic together with a sound understanding of critical development functions, e.g. Clinical Sciences, Biomarker Development, Translational Medicine

Principal Institute Research Scientist Resume Examples & Samples

Apply expert knowledge of tumor biology in areas such as immune oncology, oncogenic signaling, metabolism, epigenetics and/or DNA damage to enable target discovery, validation and drug development
Oversee and/or lead multiple cross-functional research drug discovery and development programs
Lead collaborations with computational biologists utilizing patient-centric –omic databases to identify deregulated contexts that inform on target discovery, target validation and translational biology efforts in defined tumor contexts
Oversee the design, execution, analysis and interpretation of in vitro, ex-vivo and in vivo experiments to validate targets, optimize compound selection and explore therapeutic potential of drug targets
Apply knowledge of pharmacology to enable in vivo assessment of chemical matter and establishment of pharmacodynamics, pharmacokinetic and efficacy relationships
Lead drug discovery biology efforts to enable selection of lead candidate molecules
Apply expertise to lead the discovery, validation and development of cell and molecular assays to define mechanism of action, measure pharmacodynamic changes and select patient responder populations
Lead program biology efforts to enable clinical positioning of developmental candidates
Develop and lead strong collaborative relationships with internal and external groups
Manage activity of direct reports and project teams
Evidence of independent thinking and leadership skills are vital. Ability to work well under pressure and drive projects that impact critical timelines is essential
MD or PhD with over 7 years of relevant post-degree experience in a pharmaceutical/biotech environment
Evidence of utilization of cancer genomics to inform on target discovery, validation and/or clinical positioning of development drug candidates
Experience with genetic (ie RNAi and cDNAs) and pharmacological (i.e. small molecule inhibitors or antibodies) approaches to study target biology utilizing biochemistry, cellular and molecular biology methods and assays to drive program biology
Experience utilizing mouse models of cancer to enable target discovery, validation, drug development and/or translational biology
Experience working with chemists, in vitro and in vivo pharmacologists to develop and utilize assays in support of the development of small molecules for target validation and as part of lead optimization
Extensive knowledge and experience in areas of tumor biology including, but not limited to immune oncology, oncogenic signaling, cancer metabolism, epigenetic deregulation, apoptosis and/or DNA damage and repair as evidenced by publication in peer-reviewed journals
Strong data analysis skills, ability to interpret results, design of follow-up experiments, troubleshoot issues with assay performance, and effectively present results and conclusions to co-workers, collaborators and senior leadership
Evidence of leading multi-functional teams of scientists to deliver on program objectives
Evidence of independent thinking and leadership skills

Principal Scientist Toxicology Resume Examples & Samples

Perform assessments of new and existing products for materials compliance, especially restricted materials list
Consult to product teams on regulatory matters as relates to toxicity, human health, and related physical hazardous management
Develop policy on new and emerging regulations on products and materials, especially biocides and health
Environmental toxicity impact assessments
Perform audits and support full material disclosure transparency from suppliers
Support food and water contact regulatory compliance
Drive new projects for environmental and health claim related features and functions, evaluating innovative new approaches
Hazardous waste Management
Board certification (Toxicology) or related

Principal Scientist, Respiratory Resume Examples & Samples

5+ years of experience in the Pharmaceutical or Healthcare industry, preferably in a Pharmaceutical/ Consumer Healthcare / FMCH Business with experience in Medical &/or Scientific Affairs
Project specific commercial support – claims support including the creation of Claims Support Summary (CSS) documents and coordinating review / approval of promotional activities
Implementation of scientific engagement activities
Contributor to the category/ sub-category medical team meetings
Supporting GSK through engagement with external organizations including Health Authorities, Healthcare Organizations, External Experts etc
Working as part of the Global Category Medical Affairs team support development of a Culture of High Performance
Seek, challenge and implement ways to improve personal performance within Category Medical Affairs Team based on enterprise thinking
Support Category Medical Affairs Director in ensuring medical compliance of Category products and activities to safeguard the interests of consumers and patients and GSK reputation –

Principal Pharmacometrics Scientist Resume Examples & Samples

Provide pharmacometric support for assigned projects, and proactively seek the support and input from senior AQS colleagues and AQS franchise leadership
In collaboration with Research and Development team members, AQS Franchise Head and senior AQS associates, negotiate and develop (pre/early/full) clinical trial objectives and pharmacometric deliverables
In collaboration with partners in (pre-/early/full) clinical development teams (Medical Scientific Expert/Global Program or Brand Medical Directors/ Translational Medicine Experts and AQS Franchise head), provide pharmacometric support for the quantitative evaluation of competing trial/analysis strategies assuring robust support to clinical development planning and execution and alignment with CDPs/TPPs
In collaboration with AQS franchise leadership write and execute modeling plans, and deliver reports of results
Contribute to the pharmacometric scientific content of materials for internal decision boards/regulatory/submission documents: Briefing Books, decision criteria, trial design(s), responses to trial-specific Health Authority questions
Align the IIS/AQS team (biometrician, data management, database programming, programming, medical and scientific writing) on the pharmacometric strategy and execution on assigned projects
Experience in 3D modeling of fluid dynamic systems in at least one CFD software package, preferably StarCD/StarCCM+ and or Comsol Multiphysics

Principal Scientist, Patient Resume Examples & Samples

Experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies
Minimum 5+ years post PhD, 7+ years post Master’s degree or 10+ years post Bachelor’s degree of combined pharmaceutical industry and/or academic experience in PRO research
Ability to understand, interact and responds to multiple internal and external customers

Bioassay Principal Scientist Resume Examples & Samples

Good knowledge of working practices required for working in a Bioassay laboratory (e.g. good aseptic techniques, ELISA, cell biology, cell culture, protein biochemistry etc.)
Support assay optimisation/remediation within the Bioassay area
Participate in continuous improvement initiatives, including bioassay optimisation/redevelopment and lifecycle managment
Analytical Technology Transfer
Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures
Adherence to project timelines and use of project management tools
Participate in cross-functional problem solving teams for troubleshooting, and investigations within Quality in Brinny, other MSD Sites and contract laboratories as required
Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and ongoing monitoring bioassay
Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc
Actively pursue development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc
Collaborate with internal partners (i.e. other sites, R&D) and externally with CROs
Actively Participate in a culture of Continuous Improvement and process optimisation by deploying Six Sigma tools within cross functional
BSc in a relevant Science discipline
Experience with ELISAs and leading analytical method validations
Self-motivated and ability to work as part of a team with good project management Skills
High level written and verbal communications with advanced PC skills
Knowledge and experience of operating in a development and commerical lab environment
Ph.D./M.Sc. qualification (Science)
Knowledge of and experience in applying Six Sigma and Lean methodologies,
Equipment commissioning and qualification

Principal Scientist Cardiovascular Resume Examples & Samples

Expected to promote and facilitate creative thinking from target identification/validation through lead optimization and preclinical support of clinical programs. An important aspect will be helping to drive innovative translational strategies from preclinical in vitro and/or in vivo models to human clinical research
Be a “drug creator”, and promote such thinking within the team and, by influence, your colleagues in other disciplines with whom you will work closely
Strong communication skills will be required to influence both cross-site therapy area aligned groups as well as functional area disciplines
Ability to balance internal cross-site activities with an expansive program of collaborative research with leading laboratories in the external scientific community to drive innovation and a deeper understanding of human biology resulting in the discovery of novel targets in CMD
Responsible for contributing to CMD area strategy in collaboration with senior management and play a lead scientist role on Scientific Review and Licensing committees
Participate in the leadership forums at the local site with other functional leaders. As this is a new site, it will be important that you help to shape the culture beyond the science
Strong team player with excellent oral and written communication skills
Demonstrated ability to lead cross-functional project teams
Motivate, influence, and develop & coach others will be essential in this role
Expected to encourage innovative thinking and risk taking, while eliminating obstacles and barriers in order to implement change
Ability to present clear and compelling scientific and business cases will be important
Minimum of (8) year’s industry experience, preferably in cardiovascular, or a related area
Minimum of 10 years of post-doctoral experience
Hands-on experience in ex-vivo and in vivo cardiovascular skills and willing to work in the lab
Experience in the disease area of Heart failure
Proven track record in academic basic science training
Strong knowledge of drug discovery and development
Experience in Atherosclerosis and Vascular Biology

PD Principal Scientist Resume Examples & Samples

Scientific input into development projects with regard to modified release Technologies
Scientific input into development projects with regard to bioavailability enhancement
Technical lead of formulation technicians
OHC assessment for new APIs
Drafting and execution of development concepts for already signed and new R&D projects
Support of R&D quotations and customer visits
Transfer of manufacturing processes from R&D to Operations

Engineering, Scientist, Principal Leader Resume Examples & Samples

May serve as a working leader responsible for leading and providing technical advice and direction to lower graded personnel
Duties may include, but are not limited to, monitoring work; ensuring product quality, accuracy, and timeliness; consolidating reports for COR regarding status updates and billing; and reviewing collected data for completeness, accuracy, and validity
Coordinates with others to assure all safety, security, environmental, and community concerns are adequately addressed
Undertakes and resolves difficult and highly complex technical projects through research, analysis, and the application of judgment developed from previous experiences
Provides technical insight for addressing problems that are difficult to define, require unconventional or novel approaches, and require sophisticated analytical techniques
Remains abreast of changes in the subject matter area and introduces technological/cutting edge breakthroughs into current efforts when applicable
Independently evaluates, selects and applies standard engineering techniques, procedures, and criteria
Provides independent and professional support on portions of complex projects
Specific assignment objectives, approaches, and possible solutions are reviewed for accuracy and completeness
Duties and responsibilities include, but are not limited to: independently performs a project assignment that involves complex features and can be guided by codes, standards, and other precedents of the discipline; analyzes and/or evaluates the results of an analysis using techniques prescribed by senior engineers or supervisors; and accomplishes tasks of which require investigation of a many variables
Personally observes test events as required and monitors performance of the test item and adequacy of data collection
Reviews the data collected for completeness, accuracy and validity

Single Molecule Characterization Principal Scientist Resume Examples & Samples

Development of single molecule measurements to support the development of the RSS sequencing platform
Perform single molecule investigations using TIRF, superresolution and other cutting edge microscopy techniques
Supervise other single molecule scientists and associates of different experience levels

R&D Food Safety Principal Scientist Resume Examples & Samples

Performing food safety hazard assessments on various projects/products and assisting with development of HACCP transfer documents
Reviewing and approving new ingredient specifications. Communicating directly with suppliers to assure documentation needed for food safety hazard review is obtained, including biological, chemical, allergens, and physical hazards. Documenting ingredient hazards and control measures in ingredient database supporting facility food safety plan completion
Assisting with education for R&D and Supply Chain personnel in the areas of Food Safety including FSMA Hazard Analysis and Preventive Controls, Microbiology, and Allergen management
Support global harmonization of food safety processes within PepsiCo by leading global working teams, and collaborating on supporting documents
Mentor and provide a strong professional role model for other individuals in the Food Safety and Microbiology
Designing microbiological challenge studies; and
Providing general food safety support; troubleshooting; auditing; and technical consultation
Some weekend work and travel may be required
Perform food safety hazard assessments
Co-develop HACCP transfer documents
Review and approve new ingredient specifications
Document ingredient hazards and control measures in database
Food safety education for R&D and Supply Chain personnel
Support global harmonization of food safety processes
Mentor individuals in the Food Safety and Microbiology
Design microbiological challenge studies; and
Provide general food safety support for company projects/initiatives
Minimum Education Required: Master of Science Degree in Microbiology, Food Safety, Biology or related field
Education Preferred: MS or PhD in Microbiology, Food Safety, Biology or related field
Working knowledge of food microbiological methodology and practices; GLP's and GMP's; and HACCP; and risk assessment
8+ years of experience in food microbiology within U.S. food industry
Basic computer skills - Word, Excel, PowerPoint
Excellent communication, organizational and time management

Principal Nutrition Scientist Resume Examples & Samples

25% - Program Manager Nutrition & Health: work planning, resource allocation, budgeting, dissemination and intellectual property generation
25% - Scientific leadership in CSST Group projects
20% - Nutrition lead in Ingredient Reputation Management teams, globally
20% - Bringing the outside in: through network and representing Cargill in scientific organizations, and technical meetings and conferences. Tech scouting (external) and collaborations with external partners, identifying external subsidy opportunities and participating in consortium projects
10% - Nutrition support to Sweeteners strategy and related Product Lines (specialty carbohydrates, polyols, etc.)
A PhD in Pharmaceutical Sciences, Chemistry, Biochemistry, Biology or related discipline
8 years of industry experience
Program and project management
Conduct clinical and pre-clinical trials (expertise in GCP is a plus)
Experimental design, data interpretation and presentation of results and recommendations to a variety of audiences (technical and commercial)
Publication of scientific papers (peer-review)
Leadership skills (technical/ scientific)
Superior written and oral communication skills
PC literate (Word, Excel, PowerPoint)
Knowledge of Dutch or French is desired
Feel at ease working with ambiguous situations and ability to operate independently
Eye for detail and accuracy while not losing the big picture
Creative, open minded, flexible, team player, and energetic

Principal Scientist Phage Technology Resume Examples & Samples

Managing a team of phage display/antibody engineering specialists performing phage display selections to isolate specificities for the development of therapeutic BiTE® antibody constructs
Lead innovative efforts to constantly optimize existing phage display selections (i.e. panning on cells and soluble antigens)
Represent the phage technology group in cross functional/international teams and be member of the department group leader steering committee
Doctorate degree in the field of Biology, Biochemistry, Biotechnology or equivalent
More than 7 years of in depth experience and knowledge in the phage display and antibody engineering field
Proven track record in managing diverse teams and coordinating cross functional projects
You are a highly motivated strong team worker with excellent communication and interpersonal skills
Excellent fluent English and strong presentation skills as well as high quality awareness complete your profile

Principal Scientist, Electrochemistry Resume Examples & Samples

Provide support to the business and engineering teams in the following areas
Educated to advanced degree (PhD/MSc) or equivalent experience in relevant subjects, such as chemistry, physics, engineering or other related physical scientists is highly desired
Experience of Li-ion battery technology, materials chemistry and/or electrochemistry ideally on li-ion cell technology, electrochemistry, battery materials chemistry, super capacitor cell and chemistry or fuel cell technology
Experience of managing research and development projects and being in a customer facing role
Experience of use of electrochemical device characterization equipment, tools and data analysis software is desired
Experience of providing input and support for strategic road-mapping and analysis exercises

Principal Scientist, Medical Writing Resume Examples & Samples

Lead the compilation, writing, and editing of high-quality regulatory documents and reports, including CSRs, IBs, safety narratives, safety reports, ISS, ISE, agency RTQs, and eCTD summary documents for biosimilar BLA applications
Interact directly with clients and contractors; participate in and lead discussions during meetings
Bachelor’s degree or equivalent combination and 8+ years of relevant work experience, or
Masters and 6+ years of relevant experience, or
Doctorate and 5+ years of relevant experience
10+ (15 preferred) years of experience in writing clinical and regulatory documents in all phases of regulatory submissions (clinical trial applications to ICH marketing applications)
Experience with writing clinical and regulatory documents in Regulatory Affairs, Research, Development, or related area in the Biotech/Pharmaceutical industry
Experience with biosimilars and BLAs preferred
Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
Experience in understanding and interpreting data/information and its practical application
Advanced knowledge of scientific/technical writing and editing
Organizational expert within defined subject area
Excellent written and oral communication; and strong time and project management skills

Principal Scientist, Muscle Physiology Resume Examples & Samples

Highly self-motivated, possess strong experimental and technical research skills, have strong written and oral communication skills, and be able to work productively in a collaborative and cross functional team environment within and outside of the Merck Research Laboratories
Minimum of (8) years Industry experience
Demonstrate aptitude for independent research and innovative thinking/risk taking
Experience as a project leader

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