Principal Scientist - Bioanalytical Outsourcing
About The Position
The Principal Scientist will join Regeneron’s Bioanalytical Outsourcing Team (BOT) and oversee bioanalysis of pharmacokinetics (PK), immunogenicity, and biomarkers for nonclinical and clinical programs at external contract research organizations (CROs). This includes managing assay development, qualification, and validation across analytical platforms, followed by sample analysis and reporting. The role communicates progress and status to stakeholders and requires technical proficiency, scientific rigor, independent thought, and the ability to work effectively in a team-oriented environment. The position provides scientific and operational oversight of CRO bioanalytical activities, supports CRO method design and implementation in regulated GLP/GCLP settings, coordinates with internal and external subject matter experts, and ensures quality, integrity, and timely delivery of bioanalytical work and data. The stated location is Tarrytown, New York. The posting notes that many Regeneron roles are performed onsite; applicants should confirm expectations with the recruiter and hiring manager.
Requirements
- Previous experience managing external CROs in assay validation and bioanalysis.
- Strong communication skills and ability to work efficiently in a cross-functional environment.
- Ability to work under tight timelines and adapt to changing priorities.
- Creative and strategic thinking, strong problem-solving skills, and ability to multitask.
- Hands-on experience with regulated bioanalysis, including assay validation or qualification using multiple platforms: ligand-binding assays (LBA), LC/MS, and PCR-based methods.
- Ph.D. and 10 or more years of experience in the pharmaceutical industry.
- Demonstrated technical proficiency, scientific rigor, independent thought, and ability to thrive in a team-oriented environment.
- Solid understanding of GLP and GCLP.
Nice To Haves
- Experience with novel drug candidates, such as gene therapies, CAR-T, ADCs, and AOCs.
Responsibilities
- Provide scientific and operational oversight of bioanalytical activities conducted at CROs, independently and in collaboration with BOT representatives.
- Provide critical materials to CROs, obtain required documentation, resolve scientific or operational concerns, manage standing review meetings, and arrange vendor visits as appropriate.
- Provide scientific support for CRO design, development, and implementation of analytical methods in regulated GLP/GCLP environments, ensuring alignment with current regulatory guidelines.
- Work with internal and external subject matter experts to address issues arising during assay development or sample analysis.
- Coordinate with CROs to ensure timely delivery of milestones and communicate proactively about timelines, contracts, quotes, and purchase orders.
- Review nonclinical pharmacokinetic, immunogenicity, and biomarker sample analyses and bioanalytical data to ensure data quality and integrity.
- Communicate status and progress of bioanalytical deliverables to appropriate stakeholders.
- Oversee assay development, qualification, and validation, as well as subsequent sample analysis and reporting for drug programs.
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, medical, dental, vision, life and disability insurance, paid time off, and family support benefits. Availability depends on country and role.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
