Principal Scientist, Bioanalytical Outsourcing Lead

Regeneron Pharmaceuticals Inc.; Village of Tarrytown (NY); On-site; USD 129,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k) plan

Health benefits

Wellness programs

Fitness centers

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals Inc. in New York seeks a highly skilled Principal Scientist to lead and oversee the Bioanalytical Outsourcing Team, ensuring robust PK, immunogenicity, and biomarker analyses at external CROs across multiple platforms, under GLP/GCLP frameworks.

You will direct assay development/qualification/validation, coordinate sample analysis and reporting for drug programs, and communicate progress to stakeholders with scientific rigor and strategic flair.

Qualifications

• Previous experience in managing external CROs in assay validation and bioanalysis.
• Strong communication skills and the ability to work in a cross-functional environment.
• Ability to work under tight timelines and be flexible with changing priorities.
• Hands-on experience with regulated bioanalysis including assay validation/qualification under multiple platforms: LBA, LC/MS, PCR-based methods.
• A Ph.D. with 10+ years of experience in the Pharmaceutical Industry.
• Preferred: Experience with novel drug candidates (gene therapies, CAR-T, ADCs, AOCs, etc).

Responsibilities

• Provide scientific and operational oversight on all bioanalytical activities conducted at Contract Research Organizations (CROs).
• Provide CRO with critical material and documentation; reconcile scientific or operational concerns; manage review meetings and vendor visits.
• Provide scientific support to CRO efforts in design, development, and implementation of analytical methods in a regulated environment.
• Work 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 maintain contract/quotes/purchase orders.
• Review sample analysis of pharmacokinetic, immunogenicity, and biomarkers to ensure data quality and integrity.

Skills

CRO management

Cross-functional communication

Regulated bioanalysis

Multi-tasking

Problem solving

Education

PhD in Pharmaceutical/related field

Tools

LBA platform

LC-MS

PCR-based methods

Job description

Regeneron Pharmaceuticals Inc. in New York seeks a highly skilled Principal Scientist to lead and oversee the Bioanalytical Outsourcing Team, ensuring robust PK, immunogenicity, and biomarker analyses at external CROs across multiple platforms, under GLP/GCLP frameworks.

You will direct assay development/qualification/validation, coordinate sample analysis and reporting for drug programs, and communicate progress to stakeholders with scientific rigor and strategic flair.