Principal Scientist - Bioanalytical Quality Scientist

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); On-site; USD 129,000 - 210,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension / retirement benefits

401(k) match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Senior Principal Scientist to lead biomarker assay quality within Translational Medicine. You will oversee assay development, validation, and quality assurance across platforms including molecular, NGS, IHC, and other emerging technologies.

The role requires a Ph.D./M.D. or equivalent and 3+ years in cross-functional clinical assay development. Collaboration with internal and external labs ensures robust data to support clinical

Qualifications

• Ph.D., M.D., or comparable advanced degree in a relevant scientific discipline.
• 3+ years in cross-functional teams in the pharma/biotech industry with clinical assay development, validation, and implementation.
• Broad analytical-validation experience across biomarker platforms, with molecular testing and histochemistry strengths.
• Working knowledge of regulatory requirements (CLIA/CAP), 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 pilot studies to identify and control preanalytical variables affecting assay performance.
• Partner with Global Clinical Operations and external labs to ensure assays are properly validated and implemented for clinical sample testing.
• Conduct technical assessments and site visits to evaluate analytical performance, operational rigor, and readiness to meet clinical-study needs.
• Influence internal teams and external partners to standardize specimen selection, collection, processing, storage, and quality-monitoring practices.
• Collaborate with Regeneron laboratories to translate research assays into validated clinical methods and standardized documentation.
• Improve efficiency, consistency, and scalability of assay development and validation across Precision Medicine and partners.

Skills

Biomarker assays

Analytical validation

Molecular testing

Histochemistry

Education

Ph.D./M.D. or equivalent

Job description

Build our future together: 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.

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.

When & where:

Location: Tarrytown, NY

Work model/flexibility: 4 days onsite

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.

Benefits:

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

Salary:

Salary Range (annually) $128,600.00 - $210,000.00

For jobs in Canada: this posting is for an existing position.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.