Senior Scientist, External CRO Bioanalysis

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

Job summary

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Scientist to oversee all bioanalytical activities at external CROs for nonclinical and clinical programs. You will coordinate assay development, qualification, validation, and subsequent sample analysis and reporting for each drug program.

Collaborate with internal teams to ensure GLP/GCLP compliance and manage CRO relationships to deliver milestones on time while maintaining data integrity and regulatory standards.

Qualifications

• BS/MS with 10+ years industry experience.
• Hands-on regulated bioanalysis experience.
• Assay validation across LBA, LC/MS, PCR-based methods.
• Excellent documentation and data quality.
• Clear communication of goals and timelines.
• Ability to multi-task under tight timelines.
• Experience managing external CROs (preferred).
• Experience with novel drug candidates (gene therapies, CAR-T, mAbs, ADCs).

Responsibilities

• Provide scientific and operational oversight of bioanalytical activities at CROs.
• Support design, development and validation of analytical methods across platforms.
• Ensure on-time delivery of milestones and adherence to GLP/GCLP.
• Coordinate with SMEs to resolve assay development and analysis issues.
• Review GLP/GCLP compliance status at CROs.

Skills

Regulated bioanalysis

Assay validation

Documentation

Communication

Multi-tasking

Education

BS/MS with 10+ years in industry

Tools

LBA

LC-MS

PCR-based methods

Job description

Regeneron Pharmaceuticals, Inc. in Tarrytown, NY is seeking a Scientist to oversee all bioanalytical activities at external CROs for nonclinical and clinical programs. You will coordinate assay development, qualification, validation, and subsequent sample analysis and reporting for each drug program.

Collaborate with internal teams to ensure GLP/GCLP compliance and manage CRO relationships to deliver milestones on time while maintaining data integrity and regulatory standards.