CRO Oversight Principal Scientist, Bioanalysis

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

Job summary

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Principal Scientist to lead bioanalytical outsourcing for PK, immunogenicity and biomarker work across external CROs. You will oversee assay development, qualification, validation and subsequent sample analysis, reporting in a regulated GLP/GCLP environment.

The role requires a Ph.D. with 10+ years in the pharmaceutical industry, strong communication, and cross-functional collaboration.

Qualifications

• Experience managing external CROs in assay validation and bioanalysis.
• Proven ability to communicate status and progress to stakeholders.
• Ability to work under tight timelines and adapt to changing priorities.
• Hands-on experience with regulated bioanalysis under GLP/GCLP.

Responsibilities

• Provide scientific and operational oversight of bioanalytical activities at CROs, independently and with BOT representatives.
• Coordinate with CROs for documentation, vendor visits, and issue resolution.
• Support design, development, and implementation of analytical methods across platforms (LBA, LC/MS, PCR-based).
• Collaborate with internal/external SMEs to address assay development and sample analysis issues.
• Ensure on-time delivery of milestones and maintain contract/quote/purchase order transparency.
• Review pharmacokinetic, immunogenicity, and biomarker data for quality and integrity.

Skills

Cross-functional collaboration

Communication skills

Time management

Problem solving

Bioanalytical oversight

Education

Ph.D. in Pharmaceutical Science or related

Tools

LC-MS

PCR-based assays

Bioanalytical assay development

Job description

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Principal Scientist to lead bioanalytical outsourcing for PK, immunogenicity and biomarker work across external CROs. You will oversee assay development, qualification, validation and subsequent sample analysis, reporting in a regulated GLP/GCLP environment.

The role requires a Ph.D. with 10+ years in the pharmaceutical industry, strong communication, and cross-functional collaboration.