Lead Bioanalytical Outsourcing Scientist

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 190,000 - 280,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Experienced Principal Scientist for Bioanalytical Outsourcing in Tarrytown, NY. Lead external CRO bioanalysis of PK, immunogenicity, and biomarkers, directing assay development/qualification/validation and downstream sample analysis and reporting.

You will communicate progress to stakeholders, ensure GLP/GCLP compliance, and collaborate with internal SMEs to resolve assay development and analysis issues. PhD with 10+ years in pharma is preferred.

Qualifications

• PhD with 10+ years of experience in the pharmaceutical industry.
• Experience managing external CROs in assay validation and bioanalysis.
• Hands-on with regulated bioanalysis including assay validation/qualification across multiple platforms (LBA, LC/MS, PCR).
• Strong communication skills and ability to work in a cross-functional environment.
• Ability to manage tight timelines and shifting priorities.

Responsibilities

• Provide scientific and operational oversight of bioanalytical activities at CROs, independently and with BOT representatives.
• Coordinate with CROs to obtain documentation, reconcile issues, and manage review meetings.
• Support design, development, and implementation of analytical methods in GLP/GCLP environments.
• Collaborate with internal and external SMEs to address assay development and sample analysis issues.
• Interface with CROs to ensure on-time milestone delivery and contract/PO management.
• Review pharmacokinetic, immunogenicity, and biomarker data to ensure data quality and integrity.

Skills

Scientific oversight

CRO management

Communication

Regulatory awareness

Education

PhD in Pharmaceutical Sciences or related

Tools

LBA

LC/MS

PCR-based methods

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Experienced Principal Scientist for Bioanalytical Outsourcing in Tarrytown, NY. Lead external CRO bioanalysis of PK, immunogenicity, and biomarkers, directing assay development/qualification/validation and downstream sample analysis and reporting.

You will communicate progress to stakeholders, ensure GLP/GCLP compliance, and collaborate with internal SMEs to resolve assay development and analysis issues. PhD with 10+ years in pharma is preferred.