Senior Bioanalysis Outsourcing Scientist (PK & Biomarkers)

Regeneron Pharmaceuticals; Tarrytown (GA); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals, a leading biotech company in the United States, seeks a Principal Scientist for Bioanalytical Outsourcing to oversee external CRO bioanalytical activities for PK, immunogenicity, and biomarkers in both nonclinical and clinical programs. The role requires hands-on governance of assays, validation, and regulatory alignment, with collaboration across internal teams.

The position emphasizes scientific rigor, regulatory knowledge (GLP/GCLP), and ability to operate in a

Qualifications

• Ph.D. with 10+ years of experience in the pharmaceutical industry.
• Experience managing external CROs in assay validation and bioanalysis.
• Knowledge of GLP and GCLP environments.

Responsibilities

• Provide scientific and operational oversight of bioanalytical activities at CROs.
• Coordinate with CROs on materials, documentation, and vendor visits.
• Support design and validation of analytical methods in GLP/GCLP.
• Collaborate with SMEs to resolve assay development issues.
• Ensure on-time CRO deliverables and contract documentation.
• Review PK, immunogenicity, and biomarker data from studies.

Skills

CRO management

Communication

Cross-functional work

Time management

Creative thinking

Problem solving

Bioanalysis platforms

Education

Ph.D. in Pharmaceutical Sciences

Job description

Regeneron Pharmaceuticals, a leading biotech company in the United States, seeks a Principal Scientist for Bioanalytical Outsourcing to oversee external CRO bioanalytical activities for PK, immunogenicity, and biomarkers in both nonclinical and clinical programs. The role requires hands-on governance of assays, validation, and regulatory alignment, with collaboration across internal teams.

The position emphasizes scientific rigor, regulatory knowledge (GLP/GCLP), and ability to operate in a