Overview In this role you provide scientific and operational oversight of all bioanalytical activities performed at CROs, ensuring GLP/GCLP compliance and timely delivery across nonclinical and clinical programs. You work with internal and external SMEs to design, develop, validate, and implement bioanalytical methods and to drive sample analysis and reporting. You will communicate progress to cross-functional teams and manage CRO relationships to meet milestones. This position supports Regeneron's mission to accelerate patient access to science-driven therapies and offers the chance to influence bioanalytical strategy at scale.
Compensation / Benefits- competitive total rewards package
- annual bonuses or incentive plans
- equity awards
- retirement benefits (401(k) match)
- health and wellness programs
- paid time off
Responsibilities- Oversee bioanalytical activities at CROs (nonclinical and clinical)
- Coordinate assay development, qualification, and validation across multiple platforms
- Ensure timely sample analysis, data reporting, and milestone delivery
- Communicate progress and issues to internal teams and project teams
- Assess GLP/GCLP compliance at CROs and manage documentation
- Coordinate with CROs for materials, contracts, and vendor visits
- Facilitate CRO oversight meetings and issue resolution
- Support design and implementation of regulated bioanalytical methods
Key requirements- BS/MS with 10+ years of industry experience
- Hands-on experience with regulated bioanalysis
- Hands-on experience with assay validation/qualification on LBA, LC/MS, and PCR-based methods
- Excellent documentation skills and data quality focus
- Clear, concise communication of goals and deliverables
- Ability to multi-task and work under tight timelines
- Preferred: experience managing external CROs and coordinating bioanalysis; experience with gene therapies, CAR-T, mAbs, ADCs
- strong written and verbal communication
- team collaboration
- attention to detail
- regulated bioanalysis
- assay validation/qualification
- LBA (ligand-binding assays)
