Senior Scientist, Bioanalytical Outsourcing

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); On-site; USD 180,000 - 230,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a highly motivated Principal Scientist to lead bioanalytical outsourcing efforts, overseeing PK, immunogenicity, and biomarker analyses at CROs under GLP/GCLP guidelines.

The role involves supervising assay development/qualification/validation, sample analysis, and reporting for multiple drug programs. The candidate will collaborate with internal SMEs and external CROs to ensure on-time delivery, regulatory compliance, and rigorous data quality across

Qualifications

• Experience in managing external CROs in assay validation and bioanalysis.
• Hands-on experience with regulated bioanalysis including assay validation/qualification under multiple platforms: LBA, LC/MS, PCR-based methods.
• Ph.D. with 10+ years of experience in the Pharmaceutical Industry.

Responsibilities

• Provide scientific and operational oversight on all bioanalytical activities conducted at CROs, independently and with BOT representatives.
• Provide CRO with critical material and documentation, coordinate vendor visits and reconciliation of concerns.
• Provide scientific support to CRO efforts in design, development, and implementation of analytical methods in a regulated environment.
• Collaborate with internal and external SMEs to address issues during assay development and sample analysis.
• Interface with CROs to ensure on-time delivery of milestones and manage budgets/contracts.

Skills

CRO management

Bioanalytical oversight

GLP/GCLP knowledge

LBA

LC/MS

PCR-based methods

Regulatory guidance

Communication skills

Education

Ph.D. in Pharmaceutical Sciences (or related)

Job description

Regeneron Pharmaceuticals, Inc. is seeking a highly motivated Principal Scientist to lead bioanalytical outsourcing efforts, overseeing PK, immunogenicity, and biomarker analyses at CROs under GLP/GCLP guidelines.

The role involves supervising assay development/qualification/validation, sample analysis, and reporting for multiple drug programs. The candidate will collaborate with internal SMEs and external CROs to ensure on-time delivery, regulatory compliance, and rigorous data quality across