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SENIOR PRINCIPAL SCIENTIST
Job # PRE000653
The Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) is seeking an experienced scientific leader to join the Regulated Immunogenicity / Molecular Biology Bioanalytics team. The primary role of the successful candidate will be to provide scientific and regulatory leadership to the organization in the area of assays to assess immunogenicity for biologic and vaccine programs. The successful individual must be able to provide strong scientific and strategic direction, including novel methodologies and platforms using state of the art technologies for the assessment of immunogenicity. The desired candidate must also show strong working knowledge of regulatory (GLP and clinical) immunogenicity and assay guidance and have experience in authoring and reviewing regulatory submissions and responses. The top candidates are recognized industry leaders in the field of regulated bioanalysis with respect to immunogenicity measurements for biologics and vaccines.
The successful candidate will strategically influence general and program-specific assay development with a line of site to successful product approvals. In this role as a senior scientist, responsibilities include scientifically coaching and mentoring across the group, being influential in program strategy cross - functionally across Merck's portfolio, working across industry and with health authorities to set immunogenicity assay guidance, critical review of regulatory submissions and responses, and bringing new innovations into the group. Scientific excellence in assays such as ligand binding, cell - based assays, and molecular assays, and experience in the design of experiments and setting assay cut - points is also required. Candidates without all qualifications will be reviewed and could be successful based on past achievements and a desire for continued learning.
Education Minimum Requirement:
- A Ph.D. Degree in Biology, Biochemistry, Molecular Biology, Virology, Pharmaceutical Sciences, or related area with 12+ years, a M.S. Degree with 15+ years, or B.S. Degree with 16+ years of relevant experience and sustained documented interactions with regulatory agencies
Required Experience and Skills:
- Expertise in authoring and reviewing program internal development documents and regulatory submissions and responses as well as experience interacting with Health Authorities
- Strong scientific and technical expertise in regulated bioanalytical assay design, development, and execution in support of biologics and / or vaccines in discovery, preclinical and clinical development such as but not limited to MSD, ELISA, cell base, Elispot, and Luminex.
- Independent scientist able to coach scientists through influence at various levels; encourages curiosity in others and challenges the status quo to foster innovation, well developed decision making skills
- Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross - company working groups or consortia
- Proven ability to lead the development of new, innovative approaches including experience with new assay technology evaluation and shaping scientific strategy both at the platform and program level
- Serve as point of contact in regards to program lead for PPDM BA and collaborate with various early / late development program leaders across Merck
- Excellent oral and written communication skills
- Experience leading diverse teams and driving a collaborative and inclusive mindset
- Substantial experience in regulated (GLP and clinical) bioanalytics in support of immunogenicity endpoints on biologics and / or vaccines programs
Preferred Experience and Skills:
- Vaccine, anti - viral, anti - bacterial, infectious disease and / or oncology knowledge and experience
- Background in laboratory automation and/or information management systems is desirable
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