Principal Scientist - Bioanalytical Quality Scientist

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 129,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension/retirement benefits

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Principal Scientist to lead Biomarker Assay Quality within Translational Medicine.

You will oversee assay development, validation, and quality monitoring across multiple platforms, coordinating with internal teams and external labs to ensure robust data for clinical endpoints. The role emphasizes scientific rigor, fit-for-purpose validation, and preanalytical variable control, with an on-site work model (4 days onsite) in Tarrytown, NY.

Qualifications

• Ph.D., M.D., or comparable advanced degree required.
• Proven track record in clinical assay development, validation and implementation.
• Experience with cross-functional teams in pharma/biotech is essential.

Responsibilities

• Provide independent scientific and quality oversight of biomarker assay development, validation, implementation, and ongoing performance.
• Review and approve assay-development scopes of work, analytical validation plans and quality-monitoring plans.
• Collaborate with internal labs and external laboratories to standardize assay documentation and data quality.
• Lead efforts to improve efficiency and harmonize specimen handling and preanalytical variables.

Skills

Biomarker assays

Quality oversight

Cross-functional collaboration

Molecular techniques

Education

Ph.D./MD 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. #PMQBS

Does this sound like you?

We are committed to building a workplace with an inclusive culture. 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. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually) $128,600.00 - $210,000.00

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

If you have any questions, please speak with your recruiter.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.