Senior Principal Scientist Resume Samples
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Senior Principal Scientist Resume Samples
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MC
M Cormier
Mathilde
Cormier
5058 Clyde Hill
Houston
TX
+1 (555) 623 1683
5058 Clyde Hill
Houston
TX
Phone
p
+1 (555) 623 1683
Experience
Experience
New York, NY
Senior Principal Scientist
New York, NY
DuBuque, Mann and Murazik
New York, NY
Senior Principal Scientist
- Represent Analytical Sciences on project teams and lead analytical subteams, collaborating closely with scientists from Process and Formulation Development, Biologicals Research, Clinical, Regulatory, Project Management, and Manufacturing/Quality Control to deliver robust methods and products. Facilitate work and decision making for analytical issues that affect project direction and progress
- Lead a multidisciplinary functional group. Provide leadership and technical expertise in the areas of biophysics, biostructure and protein chemistry. Design and execute the strategy and plan for further development of the existing group. Recruit and train scientists and associates in experiment design, data management and analysis. Direct research scientists to ensure program efficiency
- Deliver results with impact to project teams. Design and supervise protein chemistry efforts to support assay development and biostructure studies. Design and supervise biophysical and biostructural studies on molecular targets and mechanism of actions. Facilitate structure-based drug design and fragment-based drug discovery. Work with biologists, medicinal chemists and computational chemists to analyze structural information, understand the structure-function relationship of drug targets and address disease-related biological questions. Plan, supervise, multitask and direct projects to completion. Ensure timelines are met; communicate program objectives to cross-functional teams
- Maintain high visibility for team and department. Act in the role of Chemical Biology Lead member of project teams. Provide critical leadership and steering to projects from the perspective of Chemical Biology. Build novel technologies in protein expression, purification, biophysics and biostructure. Actively direct research for opportunities to publish the results and strive for high impact opportunities
- Promote and facilitate creative thinking from target identification/validation through lead optimization towards advancing programs primarily in the Cardio-renal and Metabolic Disease Area but also Ophthalmic and Oncology Disease Areas
- Demonstrates a broad knowledge of the field of DMPK, including a track record of influence in a DMPK-related field of study, as evidenced by a strong record of peer-reviewed publications
- May participate in due diligence assessments and may serve as the department’s direct interface with alliance partners with responsibility for risk assessment, financial and strategic planning, and project guidance responsibilities to protect the Company’s interests and resource investments
Los Angeles, CA
Senior / Principal Scientist
Los Angeles, CA
Muller-Hickle
Los Angeles, CA
Senior / Principal Scientist
- Screening assay development
- Present results to senior management and other research stuff
- Establish state-of-the art cell based assay to support protein therapeutics identification for diabetes/obesity
- Design and perform research in target discovery and validation
- Works in ambiguous situations as part of a project team with moderate uncertainty of a successful scientific outcome for some solutions attempted
- Strong, demonstrated performance in synthetic organic chemistry
- Perform a wide range of analyses (routine and non-routine) primarily but not limited to cell molecular biology areas of Biopharmaceutical Services
present
Phoenix, AZ
Senior / Principal Scientist Group Leader
Phoenix, AZ
Stracke, Von and Barrows
present
Phoenix, AZ
Senior / Principal Scientist Group Leader
present
- Coach, train, and develop others within the group with respect to their personal development and effective implementation of operational improvements
- Develop and implement operational improvements
- Performing unknown compound investigations utilizing mass spectrometry, working independently and efficiently
- Conduct semiannual performance reviews, interview applicants, keep training records up to date for assigned employees, perform succession planning in preparation for growth
- Coach and develop individual and team to maximize performance
- Documenting work clearly and performing tests accurately; contacting clients on a routine basis and being responsible for some projects
- Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
Education
Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Illinois State University
Bachelor’s Degree in Chemistry
Skills
Skills
- First-hand knowledge of the regulatory expectations for critical aspects of cell bank quality including clonality and stability
- Good organizational and planning abilities, team and communication skills, excellent command of English and proven IT knowledge
- Substantial training and knowledge in several relevant scientific / technical disciplines, with knowledge of technical issues and potential solutions
- Broad and demonstrable knowledge of other areas, both within development and manufacturing, outside of areas of scientific experts
- Demonstrated track record in developing highly productive and stable cell lines for GMP manufacture
- Knowledge of basic pharmacology in vivo/in vitro models
- Strong knowledge rocket motors, flares, aerospace vehicles and components
- Good coding practices, documentation, examples of code acceptable
- Detail oriented but able to understand the big picture
- Strong programming and scripting skills (at least 5 yrs of experience) in one or more (polyglot) of JAVA, C, C++, Python, Perl, R, Matlab, SAS environments
15 Senior Principal Scientist resume templates
Read our complete resume writing guides
1
Senior Principal Scientist Resume Examples & Samples
- Interact with project teams, CROs, internal scientists to support bioanalysis of various programs/projects at various stages
- Responsible for in-house bioanalytical support of late phase discovery support and non-GLP work in development phase
- Monitor quality and timeline of the studies
- Provide value-added inputs to project teams and act as a PDM rep for project teams
- Responsible for generating data to support compound progression and regulatory submission
- Responsible for monitoring method development, validation and sample analysis at CROs
- Responsible for data processing/analysis and communication of results
- Bring in novel sample preparation and LC-MS technologies
- A Ph.D. degree in chemistry, biochemistry, biomedical sciences, or a related field with at least 6 years of experience is required
- Supervisory experience is required
- Experience working with CROs is required
- Extensive knowledge and hands-on experience of liquid chromatography and mass spectrometry (LC-MS) is required
- Have hands-on experience for analysis of small molecules in complex biological matrices is required
- Knowledge and experience with bioanalysis method development and assay establishment is required
- Extensive knowledge of DMPK and diversified drug discovery/development knowledge is required
- Pharmacokinetics experience is required
- Track record of scientific publications and presentations is required
- Deep knowledge of regulatory guidance for bioanalysis practice and industry best practices is required
- Candidate should be recognized as a industry leader in the fieldR&D
2
Senior Principal Scientist Resume Examples & Samples
- Analyzes; evaluates; and plans methods of approach for projects and organizes means to achieve the solution of problems
- Conducts complex investigations or tests pertaining to the development of new designs; methods; materials; or processes and investigates possible applications of results
- Specifies equipment; materials and suppliers required for completion and implementation of projects
- Evaluates vendor capabilities to provide or build required services; supplies; or equipment
- Supervises assigned staff
- 10-15 years of related experience in scientific research; analysis and/or engineering
3
Senior Principal Scientist Resume Examples & Samples
- Provide technical leadership to Pall filtration products in Microelectronics Wet-Etch Chemicals market
- Study compatibility of Pall filtration technologies in advanced Semiconductor Chemicals
- Interact with external customers on issues involving product selection and use, and investigation of problems potentially involving Pall filtration products, producing reports or presentations on findings as needed
- Participate on cross-functional teams dealing with characterization of advanced filtration products
- Provide training to customers and to internal personnel on filtration topics and related technical areas, developing new training materials for this purpose as needed
- Lead a small technical team to provide advanced metrology solutions
- Represent Pall Corp in major scientific and technical conferences through leading-edge publications and presentations
- PhD in Chemistry, Chemical Engineering or Materials Science
- 5+ years of post-graduate experience in Microelectronics industry or Semiconductor Industry (Processes and/or Materials)
- 5+ years of electronic materials experience in advanced wet-etching chemicals used in semiconductor processes
- 5+ years of experience of on-wafer defectivity and metrology techniques
- 5+ years of experience in advanced materials characterization techniques
- 5 or more years of project management experience
- 10+ years of post-graduate experience in Microelectronics industry or Semiconductor Industry (Processes and/or Materials)
- 10+ years’ in electronic materials experience in advanced wet-etching chemicals used in semiconductor processes
- 5 or more years of customer interface experience
4
Senior / Principal Scientist Epigenetics Resume Examples & Samples
- Set antibody quality standards for epigenetics antibodies and ensure antibodies in the production pipeline meet quality criteria
- Manage other projects as necessary to help drive epigenetics portfolio quality
- Manage epigenetic collaborations as required for product development
- Provide and evaluate suggestions for antibody product pipeline &/or other new products, with a focus on epigenetics
- Be part of cross-department epigenetics team to develop product strategy for epigenetics products
- Some travel to conferences may be required (international & national)
5
Senior Principal Scientist Resume Examples & Samples
- Capable of designing, conducting, interpreting, and reporting in vitro and in vivo data; adept at appropriately supervising laboratory scientists responsible for conducting such studies
- Familiar with various drug metabolizing enzymes, biotransformation pathways, transporters, and chemical mechanisms
- Experience and expertise in the interpretation, analysis, documentation, and presentation of results to scientists and management at all levels. Must be able to translate complex findings to appropriate summary statements and informative slides
- Possesses creative skills leading to the development of new strategies. Additionally, functions as an acknowledged resource and technical leader externally in a specific project-relevant area
- Comfortable and confident representing DMPK on multidisciplinary project teams; able to work collaboratively and productively with colleagues in other functions such as Drug Discovery Support, Nonclinical Drug Safety, and Clinical Pharmacokinetics
- Demonstrates compliance with applicable regulations, capable of performing laboratory work in a safe manner, and able to maintain proper records in accordance with internal SOPs
6
Senior Principal Scientist, Dmpk Resume Examples & Samples
- Design and conduct in vitro and in vivo ADME experiments focused on identification of molecules for advancement in the Discovery pipeline including the following capacities
- Supervisory oversight of conduct of quality in vitro ADME, in vivo PK assays and bioanalysis
- Conduct and lead in silico modeling efforts to predict human PK and dose
- Departmental representation on multiple Discovery project teams
- Innovation in tailoring ADME experiments to address specific needs and step outside the current DMPK paradigms to critically evaluate traditionally accepted concepts
- Effective collaborations with medicinal chemistry, biotherapeutics, formulations, pharmacology, and toxicology departments
- Ability to serve as a strategic resource to resolve complex problems on discovery teams
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or other life sciences fields and a minimum of 15 years of relevant experience
- Understanding of biotransformation and metabolite identification and scientific areas beyond DMPK
- Ability to provide expert guidance and lead and/or influence discovery teams
- Demonstrated scientific excellence through laboratory skills, publications and/or leadership
- Ability to lead, motivate, and mentor DMPK scientists and assist with management of the department
- Full understanding of the conduct of ADME studies including the in-life, drug metabolism, and bioanalysis using LC/MS/MS, and analysis of data using modeling tools such as WinNonLin (Pheonix)
- Strong interpersonal communication skills and an ability to present effective and succinct points of view to influence the projects through scientific debate
- Working collaboratively with colleagues in other Departments and Project Teams
- Ability to multi-task and work in a collaborative team environment
- Enthusiasm to learn and to contribute to teams in a collaborative fashion across multiple disciplines
- Ability to partner with senior management in developing visions for novel/practical R&D directions
7
Senior Principal Scientist Resume Examples & Samples
- Provides direct on-site support to enable efficacy, PK, and toxicology studies for San Diego small molecule Drug Discovery efforts
- Provides drug substance characterization including crystallinity assessment, solubility determination, and physicochemical stability evaluation
- Offers solubility enhancement for poorly water soluble compounds by applying various solubilization techniques
- Develops understanding of the impact of physicochemical and solid state properties on drug candidate performance
- Serves as a resident pharmaceutical science subject matter expert to inform, educate, and influence Drug Discovery teams finding new chemical entities with desirable physicochemical and pharmacokinetic properties
- Provides on-going communication regarding San Diego Drug Discovery efforts to Pharmaceutical Development and partner groups to ensure organizational awareness, understanding, and alignment
- Provides input to the development of program strategy, budgets, timelines, and project development plans, as needed
- May be responsible for the technical leadership of junior scientists and contractors
- May participate in due diligence assessments and may serve as the department’s direct interface with alliance partners with responsibility for risk assessment, financial and strategic planning, and project guidance responsibilities to protect the Company’s interests and resource investments
- Builds and maintains strong working relationships with CRO/CMO partners ensuring that activities are managed collaboratively, efficiently, and effectively
- 10+ years of relevant experience in discovery and preclinical support, biopharmaceutics, preclinical formulation development, salt screening and selection, polymorph screening, solid state characterization, and drug development in the pharmaceutical industry with a demonstrated track record of scientific and leadership responsibilities
- Excellent communication, interpersonal and leadership skills to collaborate with others on projects (including both internal teams and external collaborators)
- PhD in Pharmaceutics, Pharmaceutical Science, Pharmaceutical Chemistry, Organic Chemistry or related scientific discipline required
- Minimum of 10 years experience in the pharmaceutical industry in small molecule drug discovery and development
- Demonstrated knowledge, experience, and successful track record in discovery and preclinical support, preclinical formulation development, salt screening and selection, polymorph screening, solid state characterization, and aiding formulation design
- Strong fluency in biopharmaceutics
- Established knowledge of phase appropriate formulation considerations
- Sound knowledge of pharmaceutical research and development processes
- Has a mastery of the scientific/technical concepts and techniques, applies and furthers those concepts and techniques to efficiently and effectively resolve scientific/technical issues
8
Senior Principal Scientist Resume Examples & Samples
- Translational science leader in the context of early-phase clinical trials
- Manage the selection, validation, and deployment of novel clinical-stage assay methods and analysis of data to accelerate development and provide insight into disease biology and drug mechanisms
- Design and interpret experiments to define dose-schedules, patient selection markers and other biomarker readouts, combination strategies and pathways of drug resistance for oncology programs
- Design and oversee execution of experiments to test hypotheses from clinical observations in preclinical model systems
- Present work at governance committees, internal forums, and external meetings
- Lead the planning and execution of collaborative projects with leading academic and commercial research groups worldwide
- Manage projects to successful outcomes through scientific leadership, teamwork and influence, and potentially direct reporting relationships
- Mentor research staff through instruction, coaching, and guidance
- Expert in clinical translational studies including sampling, analysis, and interpretation of multiple data types including NGS/ omic data
- Experienced translational leader able to define program priorities and strategies
- Comprehensive knowledge of cancer biology and drug development
- Strong understanding, derived from direct participation, of the design and execution of clinical trials incorporating translational science and correlative endpoints
- Expertise in biomarker discovery and development, with advanced skills in assay design, development, validation, and troubleshooting
- Broad understanding of the R&D process
- Functional group advisor/go-to person
- Demonstrate broad understanding of Drug Discovery & Development
- Recognized as expert in the field
- Serves as subject matter expert and functional group advisor on science, technology, methods, etc
- Familiar with basic business principles and focus of corporation
- Uses this knowledge to drive projects
- Has accountability for scientific strategies and timelines
- Prioritizes risks and recommend or endorse contingency plans
- Developing others beyond functional expertise
- Viewed as subject matter expert across multiple scientific subjects
- Responsible for internal and external resources
- Coordinate cross functional activities
- Role model for scientific culture
- Develop cross functional strategy
- Communicate and make recommendations to line management
9
Senior Principal Scientist Resume Examples & Samples
- Pursue and supervise leading systems and clinical immunology research towards key Celgene scientific objectives, including coordination and mentorship of junior staff as required
- 15 + years experience of inter-disciplinary computational and drug discovery research in university, hospital or biotechnology environments
- Experience with large immuno-profiling datasets including flow cytometry, cyTOF, imaging and immunohistochemistry data required
- Proven ability to collaborate and problem-solve productively as a member of an inter-disciplinary team
10
Senior / Principal Scientist Group Leader Resume Examples & Samples
- Development and validation of analytical methods used in the leachable testing of drug products by means of various procedures including HPLC/UV, HPLC/MS GC, GC/MS, and ICP-OES; Reading, understanding, and interpreting diverse analytical procedures presented in a variety of written styles
- Utilizing technical knowledge in the development of unique analytical methods (including researching projects via literature and internet)
- Documenting work clearly and performing tests accurately; contacting clients on a routine basis and being responsible for some projects
- Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
- Coordinate workflow and perform daily monitoring to meet TAT
- Conduct semiannual performance reviews, interview applicants, keep training records up to date for assigned employees, perform succession planning in preparation for growth
- Confront and address problems, concerns, and performance issues
- Coach and develop individual and team to maximize performance
- Support and promote company policies and procedures
- Perform all functions in support of and in compliance with all state and federal employment regulations
- Conducts all activities in a safe and efficient manner
- 2 or more years of pharmaceutical industry experience
11
Senior / Principal Scientist Resume Examples & Samples
- An independent research scientist contributing high quality technical/scientific results coupled with wide technical/scientific planning and input, based on advanced knowledge of their discipline
- Uses scientific judgment to apply and adapt methods and techniques to complete assignments
- Demonstrates sustained scientific creativity
- Applies technical knowledge to independently design experiments, interpret and summarize results within a project team and maybe on multiple subprojects in parallel
- Consistently delivers technology at the desired quality with high productivity in an independent and timely manner
- Makes decisions that require developing new options to solve moderately complex problems
- Works in ambiguous situations as part of a project team with moderate uncertainty of a successful scientific outcome for some solutions attempted
- Strong, demonstrated performance in synthetic organic chemistry
- BS, MS, or PhD in science or other related degree concentration, or equivalent directly-related experience
12
Senior Principal Scientist Resume Examples & Samples
- Late stage process development experience for multiple programs
- Experience with completing regulatory filings such as CMC sections of IND and BLA filings
- Solid understanding and hands-on experience in upstream process development and scale-down model development for cell culture process
- Excellent scientific understanding of cell biology and engineering principles for recombinant protein production with mammalian cell culture, including molecular biology, cell metabolism, upstream process development and scale-up
- Demonstrated scale-up and tech transfer of upstream processes for clinical or commercial manufacturing
- Solid record of accomplishments in the field of upstream process development
- Demonstrated ability in leading functional teams in multidisciplinary environment
- Demonstrated managerial and employee development skills
13
Senior Principal Scientist Resume Examples & Samples
- Act as a QCP/PK-PD lead on assigned CRST and program/project teams, deliveringQuantitative Clinical Pharmacology Strategic planning. In particular, ensure that clear strategic QCP/PK-PD direction and input is provided tostudy levelplans, designs, dose selections, PK/PD measures, strategy, and where appropriate operational expertise.Responsible for analysis, interpretation and reporting of human pharmacology results and PK-PD results from non-human pharmacology studies. Developing/managing clinical pharmacology/M&S -related aspects of clinical trial/program budgets
- Participate in implementing Model Based Drug Development using quantitative approaches to address complex questions arising during drug development. In particular, integrating PK-PD knowledge on an ongoing project basis. Accountable and responsible for assigned protocol synopsis and study report content
- As appropriate, being GED lead for the assigned project
- Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD data are generated and analysed including population PK, PK-PD modeling and simulation, meta-analysis etc, to support the project progression
- Providing recommendations for clinical doses and dosing algorithms to the clinical and Development teams and, for the project of competence, leading the quantitative clinical pharmacology contributions to all regulatory documents, leads and contributes to the writing and reviewing responses to regulatory queries
- May provide quantitative clinical pharmacology/pk-pdexpertise to discovery and due diligence activities
- Expanding and maintaining key networks of external thought/opinion/academic leaders, as well as alliances with partners from the pharmaceutical industry, ensuring publication of key clinical pharmacology studies in international, peer reviewed journals, and presentations at international scientific meetings of relevance
- Knowledge of Clinical Pharmacology and the application of Modeling & Simulation
- Proven experience in Clinical Pharmacology area
- Able to understand clinical effects, pharmacological, physiological and biochemical understanding
- Knowledge of basic pharmacology in vivo/in vitro models
- Able to understand/Interpret safety/pharmacology/toxicology data
- Experience inthe assigned therapeutic area and with surrogate marker identification and application
- Experience in managing/delivering clinical PK/PD modeling activities
- Experience in managing/delivering PBPK, population PK and IVIVE
- Understanding of mechanism-based drug interactions/In vivo/in vitro models
- General knowledge of Biopharmaceutics/Biostatistics/Pharmacogenomics
- Sufficient Knowledge of phases of Drug development
- Able to communicate quantitative clinical pharmacology PK/PD core activities at a PST/ CRST and sub-team level in a manner that promotes productive relationships
- Ability to effectively contribute to interdisciplinary team meetings and, able to effectively leading sub-teams (e.g. QCP sub-team) motivating others in matrix/departmental environment
- Able to represent function and UCB at regulatory meetings
- Understand drug development bridging strategies
- Ability to anticipate program needs and problem-solve, sharing critical data within the team and the line andproactively proposing solutions,
- Working in a matrix team based environment being the initiator of the assigned part ofdevelopment plans and studies
- Scientific expertise recognized internally and externally
14
Senior / Principal Scientist Resume Examples & Samples
- Identifying, developing, setting up and validating new in vitro assays according to the recent advance in ADME field
- Performing mechanistic, bespoke studies to answer specific question of projects
- Proficient in communication with impact
- Autonomous in decision-making, issue solving and critical mindset
15
Senior Principal Scientist Resume Examples & Samples
- Be a champion of innovation to ensure Zoetis leadership in vaccine analytical development and characterization
- Represent Analytical Sciences on project teams and lead analytical subteams, collaborating closely with scientists from Process and Formulation Development, Biologicals Research, Clinical, Regulatory, Project Management, and Manufacturing/Quality Control to deliver robust methods and products. Facilitate work and decision making for analytical issues that affect project direction and progress
- Design and conduct laboratory experiments including analytical method development, validation and transfer. Perform analytical methods necessary for the characterization and release of antigen, process and formulation samples. Design, set up, and conduct stability and other hypothesis driven studies
- Develop and/or adopt new analytical technology, as appropriate, to advance programs with significant analytical technical and timeline challenges and with a mindset of continuous improvement
- Document and communicate results in laboratory notebooks, technical reports, and oral presentations. Assist Regulatory colleagues in preparing, editing, and refining regulatory submissions for vaccines
- Lead co-development teams partnering with manufacturing and taking responsibility to set strategy, communicate and drive work to develop robust products and methods and transfer processes and assays to Global Manufacturing and Supply
- Develop constructive working relationships in both internal and external networks for the purpose of strengthening the vaccine analytical function and to align team goals with organizational objectives. May represent Zoetis at external meetings and with Regulatory agencies as appropriate
- Coach and mentor Zoetis colleagues in Analytical Sciences and provide direction to contingent workers and contractors providing support to the function
- PhD or MS in Biology, Analytical Chemistry, Biochemistry, or a related discipline with at least 10 years hands-on industry experience in biologicals and analytical method development
- First-hand knowledge of the regulatory requirements (EMA, USDA) that apply to the development of physical/chemical methods for control and release of vaccines
- Strong theoretical knowledge in the scientific disciplines that support antigen and vaccine characterization and method development, such as analytical chemistry, biochemistry and biology
- Comprehensive understanding of the tools used in antigen and vaccine characterization: ligand binding assays, PCR, cell-based assays, mass spectrometry, etc
- Demonstrated track record in developing efficient and robust analytical methods for development and manufacturing control
- First-hand knowledge of the regulatory expectations for critical aspects of vaccine filings, including product release, product characterization, and stability
16
Senior Principal Scientist Resume Examples & Samples
- Be a champion of innovation to ensure Zoetis leadership in CLD science. Apply comprehensive skills and knowledge in the discipline gained through experience in designing high-volume workflows for stable cell line transfection
- Lead through example by working hands-on at the bench to design and develop workflows for stable transfection of Chinese Hamster Ovary (CHO) cells for expression of monoclonal antibodies and recombinant proteins. Generate stable cell lines suitable for manufacture of both clinical supplies and commercial products in accord with GMP
- Establish protocols for CLD workflows that ensure clonality and stability of transfected cell lines. Author study reports that describe cell lineages and write sections of dossiers to support regulatory filings for new product registrations. This task will include the design and execution of protocols for testing of cell lines to ensure purity and identity in accord with global regulatory requirements
- Represent the CLD function on global project teams for development of new veterinary biopharmaceuticals. Contribute at the strategic level to the direction of project teams and facilitate decision making in the realm of CLD issues that affect project direction and progress
- Identify strategies that support the mid-term goals of the CLD function and some projects will be self-initiated. Such would include the initiation of programs to evaluate selected proprietary platform technologies offered for high-titer expression of monoclonal antibodies in CHO cell lines
- Coach and mentor Zoetis colleagues in the CLD team and provide direction to contingent workers and contractors providing support to the function
- PhD or MSc in Biochemistry, Molecular Biology, Cell Biology or a related discipline with at least 5 years industry experience in CLD
- First-hand knowledge of the regulatory requirements (FDA, EMA) that apply to the development of stable cell lines for GMP manufacture of biopharmaceuticals
- Strong theoretical knowledge in the scientific disciplines that support cell line development such as molecular biology, biochemistry, cell physiology, and microbiology
- Comprehensive hands-on practical experience in the current tools used in cell line development including transfection, limiting dilution, cloning and ranking (Clonepix, FACS, imaging)
- Practical experience with instrumentation for monitoring cell growth (eg: Cedex Bio HT) and evaluating both the quantity and quality of expressed proteins (Forte Bio Octet, SDS-PAGE, HPLC, etc.)
- Demonstrated track record in developing highly productive and stable cell lines for GMP manufacture
- First-hand knowledge of the regulatory expectations for critical aspects of cell bank quality including clonality and stability
17
Senior Principal Scientist TS Resume Examples & Samples
- Plans and performs advanced scientific studies on new and varied problems where only general objectives are stated
- Acts as technical liaison with customers and sponsors, to include the preparation and presentation of high-level technical information
- Interprets, organizes, and coordinates overall project assignments within an assigned scientific functional area
- Analyzes, evaluates, and plans methods of approach for projects and organizes means to achieve the solution of problems
- Establishes and defines the theoretical bases and principles which should apply and the empirical test procedures to be used
- Conducts complex investigations or tests pertaining to the development of new designs, methods, materials, or processes and investigates possible applications of results
- Interprets and evaluates test data and results of investigations and develops recommendations
- Specifies equipment, materials and suppliers required for completion and implementation of projects
- Evaluates vendor capabilities to provide or build required services, supplies, or equipment
- May serve as technical team or task leader
18
Senior Principal Scientist Resume Examples & Samples
- Ideally PhD with considerable experience
- Preferred area of study: DSP background, but will consider USP backgroun
- Substantial experience with demonstratable track record in a biopharm / biotech company, or equivalent organisation
- Broad and demonstrable knowledge of other areas, both within development and manufacturing, outside of areas of scientific experts
- Good reputation in scientific community and Lonza network
- Substantial training and knowledge in several relevant scientific / technical disciplines, with knowledge of technical issues and potential solutions
- Strong evidence for delivering on commitments, working-in and leading multi-disciplinary teams
- Confidence dealing with uncertainty and working outside scientific comfort zone
19
Senior Principal Scientist Resume Examples & Samples
- Analysis of preclinical experiments involving complex cell culture models to provide deep insight into the actions of both existing and novel therapies. Profiling data derived from a range of transcriptomic, proteomic, genomic, and wider cell-molecular assay platforms
- Early prediction of patient phenotypes associated with response to therapy, using patient profiling data from Celgene early phase clinical trials and additional data sources drawn from collaborations and the public domain
- Provide collaborative leadership to develop target prioritization, patient-centric indication prioritization, patient selection, and rational combo-therapy prediction strategies in support of Protein Homeostasis therapeutic programs
- Enable groundbreaking next-generation Protein Homeostasis therapeutic approaches with integrated informatics capabilities alongside Research Analytics colleagues
- Pursue and supervise leading computational biology research towards key Celgene scientific objectives, including line management of research staff
- Participate as a core team member in the Protein Homeostasis Thematic Center of Excellence (TCoE) leadership team
- Coordinate application of novel computational analysis and biological interpretation approaches to leverage internal, public and partner datasets and empower data-driven decisions across therapeutic programs
- Collaborate to investigate compound and disease properties and influence decisions from target prioritization through to translational development
- Oversee scientific report writing. Present methods, results and conclusions to a publishable standard
- Drive strategic informatics collaborations with academic and commercial thought leaders to benefit therapeutic programs
- A Ph.D. in computational biology, proteomics, bioinformatics, or related field from a recognized higher-education establishment
- 15+ years experience of inter-disciplinary computational and molecular/chemical biology research in university, hospital or biotechnology environments
- Strong knowledge of biological processes, cellular mechanisms, and their interpretation via computational analysis in context of neoplastic disease - preferably with focus on post-translational modification, wider proteasomal and/or immune mechanisms
- Familiarity with comparative pre-clinical therapeutic action studies that involve high-throughput molecular profiling is prerequisite, alongside ability to design and apply methods to mine public structural and genetic databases
- Knowledge of cheminformatics and/or structural biology approaches desirable
- Experience in leading pharmaceutical informatics research with track record of enabling data-driven decisions for patient benefit and peer-reviewed publication in relevant scientific journals
20
Senior Principal Scientist Resume Examples & Samples
- Veterinary degree (DVM/VMD) from an accredited veterinary school, or acceptable international equivalent in veterinary medicine
- Post-graduate research (MS or PhD) highly preferred
- Pharmaceutical development/project team/regulatory interaction experience desirable
- ACVP/ECVP Board certification required
- 6-10 years of pathology experience post-DVM; working knowledge of clinical pathology
- Specialized training and/or experience in toxicologic pathology preferred
- Experience with GLP as study director, monitor or sponsor representative
- Excellent organizational and communication (verbal and written English) skills
21
Senior Principal Scientist, Immune Modulation Resume Examples & Samples
- Effectively integrate scientific insights and drug development experience to propose immune modulation-based new therapeutic concepts (NTCs) and independently formulate research plans to enable the validation of proposed NTCs
- Lead and oversee cross-functional teams to drive NTC-based candidate selection/nomination to contribute to BI’s pipeline in immunological diseases. Function as an acknowledged resource and technical leader within and outside of the department in at least one specific area of immunology research or technology, providing guidance and expertise to support the advancement of existing pipeline and evaluation of potential in-licensing opportunities
- Assume responsibility for direct reports as needed including recruiting, managing, mentoring and developing scientific staff. Direct, oversee and mentor experimental design, data generation and interpretation of junior level research scientists
- Collaborate extensively with other members of the Immune Modulation Group in Ridgefield and globally, the larger BI’s Global Immune Modulation Biotherapeutics Discovery (IMBD) Division, as well as with members of other BI research entities such as the Inflammation & Respiratory therapeutic area. Leverage scientific expertise and external network to proactively identify and establish collaborative efforts with key academic leaders
22
Senior Principal Scientist for Process Technology Resume Examples & Samples
- The role will be accountable to deliver measurable results, by delivering new and improved cell culture development services. Working closely with business development and the Mammalian Process R & T team to understand and execute projects aligned to improve bottom line Business Unit(s) results
- This position is accountable for refining and delivering technical solutions to meet industry demands for the creation of cell lines that express recombinant proteins and monoclonal antibodies and maintain Lonza as a preferred leading supplier
- Reporting to the Head of Mammalian Process R & T
- Line management responsibility for (currently) up to 4 scientists working on a variety of Research and Technology projects
- To provide scientific and technical guidance to develop processes for biopharmaceutical development
- Makes sure that Pharma&Biotech stays ahead of the curve for its cell line and process development capabilities and services
- Working closely under the direction of the Head of Mammalian Process R & T; drives, leads and executes the Pharma&Biotech technical approach to cell line development process improvements for CD&L services
- Provides scientific direction to the R & T team members in the cell line and process development area
- Reviews and evaluates process technology platforms – define, select, develop and implement the required new technology solutions
- Involved with creating strategic relationships with scientific leaders
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Senior Principal Scientist Resume Examples & Samples
- The candidate will hold a Ph. D. in biological sciences or equivalent; have a minimum of 10 years relevant experience in the pharmaceutical industry supported by an appropriate publication record
- The successful candidate will be able to clearly demonstrate a consistent track record of impact on drug discovery programs through the judicious use of science and technology
- Experiences in the application of modern automation and miniaturization technology are important assets for this position
- Additionally, the candidate must be able to demonstrate superior assay design and screening skills for both biochemical and cell based assays especially in major target classes such as GPCR, enzymes etc
- Extensive knowledge of biochemical pharmacology, cell biology, and high throughput assay design and execution are required
- Understanding physiologically relevant models and translational approaches to drive target from concept to clinical setting will be a plus
- An ability to create and maintain an effective scientific network through teamwork, across geographic boundaries, excellent problem solving skills and an open collaborative style are of critical importance for success in this role
- Supervisory experience in a multidisciplinary environment is essential
- 1604539
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Senior Principal Scientist Resume Examples & Samples
- Ph.D. in biochemistry, chemistry, pharmaceutical sciences, or related fields
- 5 years industry experience in protein analytical development and drug product Quality Control
- Experience with HT technology and automation is a plus
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Senior Principal Scientist Resume Examples & Samples
- A PhD degree in a relevant scientific discipline and a minimum of 10 years of industrial experience with a significant portion of that experience in in vivo pharmacology with an emphasis in Immuno-oncology and the tumor microenvironment
- A proven track-record of achievement, as evidenced by publications in peer-reviewed journals, authorship of patents, and internal and/or external scientific presentations
- Proven ability to lead matrix teams, with demonstrated ability to influence team direction, manage conflict and resolve issues
- A deep understanding of the drug discovery process, from target identification and validation through development of drug candidates for clinical development. Key attributes include a deep understanding of pharmacokinetics, pharmacodynamics, in vivo immune cell profiling, and the ability to integrate PK/PD/efficacy data to drive drug candidate optimization
- The preferred candidate will also possess the following skills
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Senior Principal Scientist Resume Examples & Samples
- Develop and maintain a strong working relationship with statisticians, modelers, pharmacometricians, translational scientists and IT partners bringing a deep understanding of the science behind the clinical programs
- Maintain a keen awareness of developments in data technologies, analytics, methods and systems
- Develop data integration, management and analysis strategies aligned to Sanofi drug development priorities
- Be the go to person for data processing, analysis and analytics platform support
- Hands on implementation of analytical solutions, data access and management technologies
- Be the thought leader, publish and present internally and externally on a regular basis on data solutions and applications
- Educational training focused on data/computational sciences, statistics/mathematics, engineering with appropriate mix of experience. (i.e. Bachelors + 10 yrs experience or Masters + 8 yrs or PhD + 5 yrs. Or similar mix of aptitude for learning and scientific research)
- Strong programming and scripting skills (at least 5 yrs of experience) in one or more (polyglot) of JAVA, C, C++, Python, Perl, R, Matlab, SAS environments
- Good coding practices, documentation, examples of code acceptable
- Prior hands on experience in application development (web development, Javascript, PHP, HTML5, CSS), implementation of analytics on big data stacks (HDFS, Spark, NoSQL databases)
- Prior hands on experience (with examples) with one or more business intelligence stacks, data visualization frameworks (Spotfire, Tableau, Microstrategy etc.) and integration with big data technologies etc
- Some experience with systems integration, ETL technologies, systems and data migration (in life sciences space will be preferred)
- Familiarity with machine learning/statistical methods (Regression techniques, inference methods, probability) and tools to implement various algorithms (Weka, Knime, R, Python libraries etc.), additional skills in signal/image processing would be preferred
- Experience with automation, scripting, batch/cron jobs, writing shell/batch scripts
- A decent understanding of various life science data standards CDISC, OMOP, Mini Sentinel and familiarity with popular databases (Gene Ontology, KEGG, Pathways etc.)
- A good understanding of life sciences lab technologies and data from genomics, proteomics, metabolomics and analysis methods specific to these data types
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Senior Principal Scientist Resume Examples & Samples
- Lead a translational research group supporting immunology and inflammation research programs
- Develop strategy and technologies to conduct experiments and analytical procedures, applying a wide variety of scientific principles and concepts
- Build efficient interactions with collaborators within and outside the Immunology and Inflammation Research and Early Development Therapeutic Area
- Provide scientific expertise, establish and manage external scientific collaborations, monitor external market, and provide critical assessment
- Manage direct reports, including scientists and research associates. Provide scientific support to train the team, and promote their career development
- Prepare publications, research and clinical/regulatory documentation in accordance with Sanofi quality standards
- Track record of recent scientific publications and high level of proficiency with mechanistic studies of human immune regulation
- Track record of pre-clinical drug discovery including moving scientific targets into early clinical development
- Experience with in vitro functional assays using human immune cells is highly desirable
- Strong people organizational and presentation skills
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Senior Principal Scientist Resume Examples & Samples
- Develops strategy and technologies relevant to the autoimmunity to conduct experiments and analytical procedures, applying a wide variety of scientific principles and concepts
- Coordinates research efforts and makes key technical contributions affecting the direction of the group and/or project
- Track record of excellent recent scientific publications and high level of proficiency with mechanistic studies of human immune regulation
- Previous experience in managing scientists
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Senior Principal Scientist Pharmacokinetics Resume Examples & Samples
- A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related field with a specific focus on pharmacokinetics
- 5 years pharmaceutical industry experience in the conduct of pharmacokinetic support
- Experience as a team member on interdisciplinary project teams, with experience on biotherapeutic projects essential
- Experience in preparing PK reports appropriate for regulatory submission and authoring relevant components of regulatory filing documents
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Senior.principal Scientist Toxicologist Resume Examples & Samples
- PhD or DVM and post-doctoral experience
- 4-6 years of relevant industry experience
- Knowledgeable about regulatory nonclinical testing requirements for pharmaceutical development of small molecules and biotherapeutics
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Senior Principal Scientist Biostatistician Resume Examples & Samples
- Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics
- Lead the interaction 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/vaccine projects
- Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants
- The incumbent may initially work in a specific disease area (Oncology)
- Primary activities
- Lead a team of statistical and/or programing staff assigned to a development project as needed
- Lead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis
- May lead a team of statisticians and statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
- Represent biostatistics in regulatory interactions including presentation at advisory committee meetings
- Lead research activities for innovative statistical methods and applications in clinical trial development
- Collaborates in publication of research results in areas of applications
- Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee works as needed
- Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V
- An understanding of biology of disease and drug discovery and development. Oncology clinical trial experience preferred but not required
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Senior Principal Scientist, Chemistry Resume Examples & Samples
- Initiating, maintaining and extracting value from research collaborations with third parties (e.g., academic institutes and hospitals) aimed at the discovery and/or validation of novel therapeutic targets and/or medicines
- Active participation in recruitment, training and development of scientific staff at all levels including mentorship of other project leaders
- Conducting due diligence review and providing recommendations on potential licensing opportunities
- Maintaining a substantial external scientific presence including authoring significant scientific publications and presentations
- Minimum of 12 years of medicinal chemistry experience
- Experience leading drug discovery projects that have delivered clinical candidates
- Significant track record of leading programs that delivered clinical candidates, including FDA approved medicines
- Extensive publication record
- Experience managing recruitment of scientific staff
- Experience initiating new drug discovery programs
- Experience conducting due diligence
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Senior / Principal Scientist, Immunologist Resume Examples & Samples
- PhD in Immunology or extensive professional work experience in cellular immunology
- 8+ years of drug discovery experience with a record of important contributions to development of novel clinical candidates
- Recognized scientific expert in immunology. Strong record of external publications and presentations
- Expertise and a deep understanding of the cellular immune components, and their role in autoimmune diseases and inflammation
- Demonstrated experience in independently leading, designing and executing experiments focused on autoimmune diseases in context of T/B cell activation, effector function and/or regulation
- Experience in working within and leading matrix teams is required
- Strong communications skills are required
- Outstanding written and oral presentation capabilities
- Experience as an effective line manager of cell biology lab scientists. Strong capabilities to teach and mentor lab scientists
- Record of success in working effectively with external research organizations, including academic institutions, contract research organizations, and/or public-private consortia
- Experience as a drug discovery program team leader is preferred
- Expertise in one or more of the following therapeutic areas: Oncology, Immunology, and Infectious Diseases is a strong asset
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Senior Principal Scientist Resume Examples & Samples
- Possession of a Doctoral degree (e.g., D.V.M., D.Sc., M.D., or Ph.D.) from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) appropriate to biomedical research
- A minimum of ten (10) years of post-graduate experience, including at least five (5) years at a Senior Scientist level
- Five (5) or more years of experience managing complex programs
- Demonstrated skills and understanding of nucleic acid based assays such as PCR, RTPCR, next generation sequencing (Whole Exome and Whole Genome), next generation RNA sequencing, ctDNA and other molecular and genomic assay technologies
- Basic understanding of next generation sequencing data analysis pipelines
- Experience with assay development, validation and trouble-shooting
- Experience with the research, diagnostic and clinical application of assays
- Experience managing groups and complex projects from inception to successful completion
- In depth knowledge and experience in cancer biology
- Demonstrated ability to work independently on a complex project(s), or development of techniques and procedures
- First or senior authorships on peer-reviewed publications, attendance and presentation at national and international meetings, high citation record
- Ability to effectively supervise and motivate staff
- Clinical trial experience
- Familiarity with drug development processes
- Knowledge covering all aspects of sample handling (sample logging and tracking databases, pre-assay analytics, assay quality assurance and result reporting)
- A solid knowledge of oncology and related biomarkers
- Excellent team player driven to achieve success
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Senior Principal Scientist Resume Examples & Samples
- Candidate must have a minimum of 5 years of Physical-Organic Chemistry experience
- Must be able to obtain a Secret clearance
- Experience in thermochemical and combustion analysis
- Demonstrated experience in melt-pour, pressure casting, and granulation and pressing
- Knowledge and demonstrated experience in polymer chemistry and decomposition reaction mechanisms, manufacturing process control and methodologies, facility and process design, and hazards characterization
- Broad understanding of statistical methods and their application in aerospace
- Strong knowledge rocket motors, flares, aerospace vehicles and components
- Extensive experience with design of experiments, SPC, variance analysis, Monte Carlo methods
- Strong skills in a wide variety of statistical methods and their application
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Senior Principal Scientist Resume Examples & Samples
- A PhD degree in a relevant scientific discipline and a minimum of 10 years of industrial experience with a significant portion of their academic and industry experience in immunology/inflammation/oncology
- A proven track-record of achievement, as evidenced by leadership of drug discovery teams which delivered drug candidates into clinical trials, publications in peer-reviewed journals, authorship of patents, and internal and/or external scientific presentations
- Proven ability to lead teams directly and to lead matrix teams, with demonstrated ability to influence team direction, manage conflict and resolve issues
- A deep understanding of the drug discovery process, from target identification and validation through development of drug candidates for clinical development
- Key attributes include deep expertise in genetic and pharmacologic target validation, immune cell assay design, the design and execution of drug discovery screening trees, pharmacokinetics, pharmacodynamics, and in vivo immune cell profiling,
- Evidence of independent design of novel experimental approaches
- Familiarity with bioinformatics databases and data analysis
- A working knowledge of Flow cytometry
- Demonstrated ability to supervise direct PhD and BS/MS reports, providing prompt and accurate technical and performance feedback and development support
- Have excellent written and oral communication skills in order to provide frequent feedback to supervisor, team and governance bodies
- Possess a high level of critical scientific thinking, high energy, independence, a strong desire to learn new areas, and the ability to work in a highly dynamic flexible team-oriented and transparent research organization
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Senior Principal Scientist Resume Examples & Samples
- Design, validate, and implement new analytical methods / preformulation / formulation and production processes in support of the drug product development process, including all necessary procedures, training, and regulatory documentation
- Participate on project teams as member, leader, or liaison to facilitate the team’s activities and achievement of goals
- Identify innovative methods/improvements applicable to the drug development process
- Direct team activities to meet specified department and corporate goals and timeframes
- Effectively interpret and defend analytical data and reports and interact with Regulatory Affairs in response to official inquiries
- Document all laboratory activities and prepare summary reports, memos, SOPs, and other required documents necessary to support projects
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Senior Principal Scientist Resume Examples & Samples
- The candidate must have a Ph.D. in a relevant biological discipline and a minimum of 10-12 years of relevant experience
- Extensive wet lab molecular biology experience is required, including a variety of expression profiling methods
- Relevant bioinformatic skills essential
- Experience directly leading small research teams and working with larger matrix teams in a drug discovery environment is required
- A track record of scientific productivity documented in peer reviewed journals is required
- Excellent communication skills, evidence of innovative thinking, and documented ability to function at a high level in a highly matrixed environment is required
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Senior Principal Scientist Resume Examples & Samples
- We ask you to provide a biomarker plan (including time lines/ time frame, data analysis plan) and to identify and prioritize biomarker platforms. Furthermore you will define the sampling strategy for a given project
- The delivery of biomarker-specific sections of project-level documentation is up to your hands
- In addition, you support the preparation, review and presentation development to internal governance bodies as well as for external communication
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Senior Principal Scientist Resume Examples & Samples
- PhD or equivalent in Electrical Engineering or Computer Science
- 8+ years post PhD research experience in Computer Vision algorithms
- 3+ years in current leading computer vision techniques such as deep learning/ Convolutional Neural Networks (CNN)
- 5+ years’ experience in an industrial research lab leading teams with 5 or more members
- Multiple examples of successful proposals to corporate and/or government funders for substantially funded projects
- Multiple examples of delivering cutting edge research to business divisions for substantial functionality in products
- Strong reputation in the computer vision research community with strong record of accomplishments and leadership in world-leading research organizations
- Proven track record in identifying new application problems and ability to invent viable solutions to solve the problems
- Ability to lead project planning and coordination across different locations
- >10 issued patents and tens or more pending
- Excellent communication skills, interpersonal skills, good team spirit, and adaptability
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Senior Principal Scientist Resume Examples & Samples
- A Ph.D. in pharmacokinetics or other related discipline, with ≥8-year industrial experience, is required
- A sound understanding of PK and PD principles and demonstrated problem-solving skills are essential to this job
- Hands-on modeling experience is a significant plus
- In addition, strong communication skills and ability to influence and cooperate in a multi-discipline team setting are required for this function
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Senior Principal Scientist Resume Examples & Samples
- Representing the formulation function at project team meetings; being an active and engaged project team member to deliver valuable new products on ambitious timelines
- Collaborating with other scientists from a variety of disciplines such as analytical chemistry, process chemistry, clinical, pharmacokinetics, safety, project management, marketing and manufacturing to achieve identified project goals
- Forging partnerships with manufacturing organizations for efficient development of well-characterized and robust processes and products
- Innovating, to differentiate and add value to the Zoetis portfolio
- Writing development reports and collaborating to prepare regulatory filings
- Leading CMC teams of scientists from chemistry, formulation, analytical, clinical supply, regulatory, manufacturing and related functions for drug candidates from the early discovery stage to registration and commercialization
- Communicating effectively to senior Zoetis management on projects, technologies and strategy
- Coaching and mentoring direct and indirect reports
- Developing and/or expanding one’s own scientific expertise as well as enhancing and advancing the expertise of those reporting to him/her
- Ph.D. with at least 10 years (or M.S. with 20 years) of industrial formulation experience, ideally including early formulation research and scale-up/technology transfer of processes to commercial production
- Demonstrated ability to collaborate, lead and develop people
- Knowledge and practical experience with physicochemical characterization of drug substances and experience with preformulation research of various types of solid and liquid dosage forms
- Ability to apply pharmaceutical science knowledge to assist R&D in selecting new chemical entities
- Interpersonal skills resulting in superior abilities to collaborate with scientists in a variety of disciplines including chemistry, analytical, pharmacokinetics, clinical, safety, regulatory, manufacturing, marketing and quality assurance
- Coaching, mentoring and team building skills to produce an excellent team
- Proven track-record in bringing formulations from early stages through commercial production including regulatory approval
- Experience in collaborating with academicians, consultants and contract research organizations
- International R&D experience and/or ability to work effectively across cultures
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Senior Principal Scientist, Biotherapeutics Resume Examples & Samples
- Functions as a project leader for Skill center activities and understands both the NBE process and project-specific biology sufficient to optimize Biotherapeutics Discovery contributions.The individual will have had a significant track record of high level impact on a clinical or technology portfolio
- Demonstrates clear understanding of research team goals and works effectively toward achieving them; Has ability to participate as co-leader or representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals
- Identify and implement strategies to generate and optimize antibodies and multi-specific molecules
- Work with multi-disciplinary groups, including CRO’s, recombinant antibody discovery, lead engineering, protein characterization, protein expression and with disease-related matrix teams to ensure optimal lead selection
- Establish an international reputation in area of expertise; represent BIPI as a scientific leader in field of expertise at both internal and national/international conferences, meetings and organizations
- Prepares clear technical reports, publications and oral presentations. Independently communicates results in the form of reports and or presentations; Presents responsibly and defends own work at scientific meetings; May deliver project updates to senior level management
- Keeps abreast of relevant literature and serves as resource in area of specialized expertise; Develops and maintains outside visibility
- Assumes responsibility for direct reports as needed including recruiting and managing; Mentors and develops scientific staff; Directs and oversees experimental design and results of technicians and junior level scientists
- Lead author publications, patents and conference presentations
- Needs experience in one or more of the skills listed above, along with knowledge of the skill center process and the ability to apply those skills to the process. Requires international travel and collaboration. Requires personnel management of experienced professionals
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Senior Principal Scientist Resume Examples & Samples
- Serves as primary technical consultant / advisor for other scientists and management
- Directs laboratory work and ensures deliverables
- Provides project leadership including technical progress and financial review
- Serves as consultant / advisor to other scientists and management
- Prepares technical reports
- Supervises laboratory staff
- Conducts laboratory investigations for anomalous results in a compliant and thorough manner
- Serves as a highly technical pharmaceutical analysis expert
- Directs physical, wet chemical and instrumental analysis, including HPLC and GC
- Develops technical proposals and estimates project costs
- Keeps current in new analytical capabilities and advises management on industry trends and business opportunities
- Provides an expert interpretation of laboratory results and designs experiments
- Prepares analytical reports and documentation for regulatory filings
- Effectively communicates with managers on project status and problems encountered
- Provides training, supervision and scheduling assistance for Technicians and Chemists
- Develops training programs
- May lead laboratory safety programs
- Contribute to patents and the scientific literature
- Pharmaceutical analysis expert with advanced training
- Good working knowledge of the pharmaceutical industry and regulatory requirements (open to new graduates MS or PhD with strong knowledge of interactions and reactions between molecules)
- Ability to exercise independent intellectual judgement based on the individual’s specialized skills in pharmaceutical analysis
- Demonstrated program management skills
- Good laboratory technique and able to train others
- Advanced troubleshooting and method development skills
- Technical project leadership abilities
- Safety minded in performance of duties
- Quality minded with ability to perform work with accuracy and in accordance with established procedures
- Effectively communicates with Manager, team members, and Senior Management
- Organized and able to perform duties in a timely manner
- Innovative
- Senior title will be based on level of experience, candidate can be brought in at the scientist level
- Recent PhD Graduates with organic/analytical expertise welcome to apply
- Minimum: Bachelor’s or Master’s degree in chemistry or related scientific field with approximately fifteen years experience in a pharmaceutical analysis
- Preferred: PhD degree in chemistry or related scientific field with ten years experience in pharmaceutical analysis
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Senior / Principal Scientist Resume Examples & Samples
- Document work as required for GMP compliance
- PhD preferred, MS with at least 3 years experience will be considered
- Extensive experience in molecular and/or cell biology, as well as method development experience
- At least five years hands on experience in a molecular/cell biology laboratory; industry and/or contract testing experience desired
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Senior Principal Scientist Resume Examples & Samples
- Lead a multidisciplinary functional group. Provide leadership and technical expertise in the areas of biophysics, biostructure and protein chemistry. Design and execute the strategy and plan for further development of the existing group. Recruit and train scientists and associates in experiment design, data management and analysis. Direct research scientists to ensure program efficiency
- Deliver results with impact to project teams. Design and supervise protein chemistry efforts to support assay development and biostructure studies. Design and supervise biophysical and biostructural studies on molecular targets and mechanism of actions. Facilitate structure-based drug design and fragment-based drug discovery. Work with biologists, medicinal chemists and computational chemists to analyze structural information, understand the structure-function relationship of drug targets and address disease-related biological questions. Plan, supervise, multitask and direct projects to completion. Ensure timelines are met; communicate program objectives to cross-functional teams
- Maintain high visibility for team and department. Act in the role of Chemical Biology Lead member of project teams. Provide critical leadership and steering to projects from the perspective of Chemical Biology. Build novel technologies in protein expression, purification, biophysics and biostructure. Actively direct research for opportunities to publish the results and strive for high impact opportunities
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Senior Principal Scientist, Process Research Resume Examples & Samples
- Lead in defining research and development project goals; direct and perform scientific experiments with a predefined goal; propose and open new R&D areas independently; Keep abreast of relevant literature and maintain a high level of expertise in own field with internal and external recognition
- Collaborate with scientists within and outside the department in identifying, defining and executing R&D goals; Formulate multi-disciplinary team approaches to reach goals; Assume leadership role for department project teams or act as a technical leader in expertise areas to enable the team to achieve project milestones, as per requirement
- Serve as a role model for effective communication; Effectively deliver project updates to department and R&D Sr. management in the context of overall project goals; Foster effective communication across R&D; Lead in R&D multi-disciplinary teams, when needed
- Responsible for maintaining/managing publication/presentation/patent record as appropriate for discipline
- Demonstrate strong knowledge in API development; Function as an acknowledged resource and technical leader within and outside of the department in expertise areas; Apply knowledge and awareness of overall business, competitive and scientific aspects of the pharmaceutical industry to influence direction of R&D projects
- Manage all aspects of laboratory operations; Recruit, manage, mentor, coach, evaluate and develop scientific staff; Take responsibility for group productivity
- Demonstrate awareness of overall departmental budget; Propose and implement new technologies and concepts to impact business; Implement and facilitate changes; Suggest capital equipment and/or external research contracts as appropriate; Assume specific responsibilities for departmental operations, if needed
- Ensure that all group members are trained and comply with all regulations and policies; Perform all work in a safe manner; Maintain proper records (notebooks, batch sheets, etc.) per relevant SOPs
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Senior Principal Scientist Resume Examples & Samples
- Represent SALAR on discovery teams and participate in therapeutic area discovery governance committee reviews
- Promote and facilitate creative thinking from target identification/validation through lead optimization towards advancing programs primarily in the Cardio-renal and Metabolic Disease Area but also Ophthalmic and Oncology Disease Areas
- Be a “drug creator” and promote such thinking by influencing both cross-site disease area aligned groups as well as functional area disciplines
- Be responsible for contributing to disease area strategy in collaboration with senior management and play a lead scientist role on Scientific Review committees
- The individual may also lead early development teams, informing on preclinical studies to support product development
- Define the appropriate in silico, in vitro and in vivo studies, including the design, dose selection, and timing to help innovate and select candidates with the highest probability of success, and collaborate with SALAR and discovery scientists to assure the appropriate conduct of these studies
- Effectively communicate the safety de-risking strategies, study data and conclusions to discovery teams, governance committees, and management
- Collaborate with the discovery and SALAR scientists to address other scientific issues including assessment of efficacy, metabolism, formulation and purity of drug product and substance
- Work closely with the SALAR development compound leaders and therapeutic area leaders to align on development plans, to facilitate a smooth transition of discovery programs into development and to assure the highest probability of success for the initiation of first-into-man studies
- Provide due diligence support for licensing efforts of targets and candidates
- Contribute to the planning and implementation of exploratory and mechanistic studies supporting discovery teams
- Minimum of 10+ years of demonstrated pharmaceutical industry experience as a non-clinical safety scientist (e.g. Toxicology, Pathology etc.) and/or as non-clinical safety assessment representative to a cross-functional development and/or discovery teams
- Excellent communicator who know when and how to speak up and appropriately raise issues to appropriated stakeholders and to management; keeps both team members, colleagues and management full apprise of project/initiative status and issues
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Senior Principal Scientist Resume Examples & Samples
- Strong knowledge of chemistry and metabolism of chemicals and pharmaceuticals in the context of toxicology and genotoxicity
- Experience with the generation and interpretation of software (Q)SAR predictions. A minimum of 5 years practical FDA experience as a pharm/tox reviewer is required, including review of nonclinical PK/ADME, safety pharmacology, general toxicology, genetic toxicology, developmental and reproductive toxicology, and carcinogenicity
- Excellent communication (oral and written) and collaboration skills
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Senior / Principal Scientist Resume Examples & Samples
- Design and perform research in target discovery and validation
- Screening assay development
- Establish state-of-the art cell based assay to support protein therapeutics identification for diabetes/obesity
- Propose, explore and implement relevant new technology in the field of molecular biology/in vitro biology
- Supervise research associates
- Present results to senior management and other research stuff
- Scouting within diabetes/obesity/CVD for new project idea initiation and evaluation
- May lead early stage drug discovery effort
- Ph.D. in biology or relevant areas with minimum 2-3 years of postdoctoral training experience
- Proven record of productivity
- Independent and innovative researcher
- Must have demonstrated knowledge in the field of metabolic diseases (diabetes, obesity, cardiovascular disease, etc.)
- Strong written and verbal communication skills, fluent in English, overseas experience preferred
- Excellent team player and collaboration skills
- Industrial experience preferred
