Principal Scientist - Bioanalytical Quality Scientist
About The Position
Regeneron is seeking a Senior Principal Scientist to serve as a Biomarker Assay Quality Lead within Translational Medicine. In this highly collaborative, matrixed role, the scientist provides independent oversight of externally led biomarker assay development, validation, implementation, and quality monitoring to help ensure assays supporting clinical development are scientifically rigorous, fit for purpose, and consistently high quality. The role partners with internal teams and external laboratories to strengthen assay strategies, minimize the impact of preanalytical variables, and deliver reliable biomarker data that support clinical endpoints and development decisions. From project initiation through closeout, the scientist reviews and approves scopes of work, development and validation plans, quality-control strategies, final validation reports, and biomarker analytical reports. The position is based in Tarrytown, New York, with four days onsite.
Requirements
- Ph.D., M.D., or comparable advanced degree in a relevant scientific discipline.
- At least 3 years of experience contributing to cross-functional teams in the pharmaceutical or biotechnology industry, including at least 3 years in clinical assay development, validation, and implementation.
- Broad analytical-validation experience across biomarker platforms, with particular strength in molecular testing, including DNA and RNA methods, and histochemistry.
- Deep understanding of the scientific and operational challenges involved in developing, validating, and implementing biomarker assays in clinical development.
- Working knowledge of relevant regulatory requirements, CLIA/CAP expectations, fit-for-purpose validation principles, and industry best practices.
Responsibilities
- Provide independent scientific and quality oversight for biomarker assay development, validation, implementation, and ongoing performance across multiple technology platforms.
- Review and approve assay-development scopes of work, analytical validation plans, quality-monitoring plans, final validation reports, and biomarker analytical reports.
- Define fit-for-purpose validation strategies and design pilot studies to identify and control preanalytical variables that may affect assay performance.
- Partner with Global Clinical Operations and external central, specialty, contract research, and diagnostic laboratories to ensure assays are properly validated and implemented for clinical sample testing.
- Conduct technical assessments and site visits as needed to evaluate analytical performance, operational rigor, scientific quality, and readiness to meet clinical-study needs.
- Influence internal teams and external partners to standardize and harmonize specimen selection, collection, processing, storage, and quality-monitoring practices.
- Collaborate with Regeneron laboratories, including Discovery Research, Molecular Profiling, the Regeneron Genetics Center, DNA Core, and Bioanalysis, to translate research assays into validated clinical methods and standardized assay documentation.
- Improve the efficiency, consistency, and scalability of biomarker assay development and validation across Precision Medicine and partner organizations.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
