New · posted Nov 10
Regeneron · Biotechnology
Principal Scientist - Bioanalytical Quality Scientist
- Tarrytown, NY
- Hybrid
- Full-time
- Senior & Principal
The role
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.
What you need
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.
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, and 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. If you have any questions, please speak with your recruiter.
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.
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.
What you'll do
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.
Pay and benefits
$128,600 – $210,000 a year
Employer provided$128,600.00 - $210,000.00
Annual bonuses or incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Tarrytown, NYHybridOpen in Maps (opens in a new tab)
More jobs in Tarrytown, NYWorking conditions
When & where
- Location: Tarrytown, NY
- Work model/flexibility: 4 days onsite
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 37% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in the US36 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $128,600 | — | $210,000 |
| All US (middle half) | $105,250 | $123,250 | $139,375 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 96 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods12
- Validation and qualification12
- Collaboration and leadership5
- Documentation and SOPs3
- Clinical trial conduct2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Validation & CQV work in biotechnology, each linked to the agency or standards body that publishes it.
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ISOISO 15189(official source, opens in a new tab)Quality and competence of medical laboratories
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
Company hiring pulse
Regeneron on Regulatory Jobs
- 174
- Open roles
- 174
- Distinct roles
- 12
- Locations
By discipline
- Clinical74 42%
- Quality73 42%
- Regulatory28 16%
By level
- Manager54 31%
- Associate & Specialist53 30%
- Director52 30%
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Principal Scientist - Bioanalytical Quality Scientist at Regeneron
Open until filled. $129K–$210K a year, employer provided.