Principal Scientist - Bioanalytical Quality Scientist
Regeneron Pharmaceuticals
Summary
Regeneron is seeking a Senior Principal Scientist to serve as a Biomarker Assay Quality Lead within Translational Medicine. In this highly collaborative, matrixed role, you will help ensure that biomarker assays supporting clinical development are scientifically rigorous, fit for purpose, and executed to consistently high quality standards. You will provide independent oversight of externally led assay development, validation, implementation, and quality monitoring across a broad range of platforms, including molecular and next-generation sequencing assays, immunohistochemistry and AI-enabled pathology, ligand-binding assays, proteomics, LC-MS and metabolomics, flow cytometry, qPCR/qRT-PCR, and emerging technologies.
Job description
You will partner 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, you will review and approve scopes of work, development and validation plans, quality-control strategies, final validation reports, and biomarker analytical reports.
Discover your role
- 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.
This role requires
- A Ph.D., M.D., or comparable advanced degree in a relevant scientific discipline.
- 3+ years of experience contributing to cross-functional teams in the pharmaceutical or biotechnology industry, including at least three 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.
Requirements
- Ph.D., M.D., or comparable advanced degree in a relevant scientific discipline
- 3+ years of experience contributing to cross-functional teams in the pharmaceutical or biotechnology industry
- At least three years in clinical assay development, validation, and implementation
- Broad analytical-validation experience across biomarker platforms
- Strength in molecular testing, including DNA and RNA methods, and histochemistry
- Deep understanding of scientific and operational challenges 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
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, Dental & Vision
- Life and disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.