Senior Bioanalytical Outsourcing Scientist

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); On-site; USD 94,000 - 153,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Scientist to oversee bioanalytical activities at external CROs, coordinating assay development/validation across LBA, LC-MS, and PCR-based methods.

The role requires GLP/GCLP compliance, strong documentation, and collaboration with internal and external teams in a fast-paced, team-driven environment. You will communicate progress to nonclinical and clinical colleagues, ensure on-time milestones, and contribute to drug programs with rigorous scientific

Qualifications

• BS/MS with 10+ years experience in an industry setting.
• Hands-on experience with regulated bioanalysis.
• Hands-on experience with assay validation/qualification across multiple platforms: LBA, LC/MS, PCR-based methods.
• Excellent documentation skills with attention to detail and data quality.
• Ability to clearly communicate project goals and deliverables internally and externally.
• Ability to multi-task and work under tight timelines.
• Preferred: experience managing external CROs and coordinating bioanalysis/assay validation.
• Preferred: experience with novel drug candidates (gene therapies, CAR-T, mAbs, ADCs).

Responsibilities

• Provide scientific and operational oversight on bioanalytical activities at CROs.
• Support design, development, and implementation of analytical methods in GLP/GCLP environments.
• Collaborate with SMEs to address assay development and analysis issues.
• Interface with CROs to ensure on-time delivery of milestones and manage contracts, quotes, and PO processes.
• Provide CRO with materials, documentation, and assist with issue reconciliation.
• Review GLP and GCLP compliance status at CROs.

Skills

Bioanalytical oversight

Regulatory GLP familiarity

Communication

Team collaboration

Education

BS/MS in relevant field

Tools

LC-MS

LBA

PCR-based methods

GCLP

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Scientist to oversee bioanalytical activities at external CROs, coordinating assay development/validation across LBA, LC-MS, and PCR-based methods.

The role requires GLP/GCLP compliance, strong documentation, and collaboration with internal and external teams in a fast-paced, team-driven environment. You will communicate progress to nonclinical and clinical colleagues, ensure on-time milestones, and contribute to drug programs with rigorous scientific