Principal Scientist, Bioanalysis Outsourcing Lead

BioSpace; Village of Tarrytown (NY); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron in Tarrytown, NY is seeking a Principal Scientist to oversee all bioanalysis conducted at CROs, including PK, immunogenicity, and biomarkers, and to manage method development and validation across LBA, LC-MS, and PCR-based platforms.

The role requires strong communication, cross-functional collaboration, and the ability to drive on-time delivery while maintaining GLP/GCLP compliance and working with external CROs in a regulated environment.

Qualifications

• Previous experience in managing external CROs in assay validation and bioanalysis.
• Strong communication skills and the ability to efficiently work in a cross-functional environment.
• Ability to work under tight timelines and be flexible with changing priorities.
• Ability to think creatively and strategically with strong problem-solving and multi-tasking skills.
• 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 aspects of bioanalytical activities conducted at CROs, independently and in collaboration with team members.
• Provide CRO with critical material and documentation, manage standing review meetings, and coordinate vendor visits.
• Support CRO efforts in design, development, and implementation of analytical methods in a regulated environment.
• Collaborate with internal and external SMEs to address assay development and sample analysis issues.
• Interface with CROs to ensure on-time delivery of milestones and contract logistics.
• Review sample analyses and bioanalytical data to ensure data quality and integrity.

Skills

Communication skills

Cross-functional collaboration

Problem solving

Multi-tasking

Creative thinking

Regulated bioanalysis

Education

Ph.D. in Pharmaceutical Sciences or related

Tools

LBA platform

LC-MS

PCR-based methods

Job description

Regeneron in Tarrytown, NY is seeking a Principal Scientist to oversee all bioanalysis conducted at CROs, including PK, immunogenicity, and biomarkers, and to manage method development and validation across LBA, LC-MS, and PCR-based platforms.

The role requires strong communication, cross-functional collaboration, and the ability to drive on-time delivery while maintaining GLP/GCLP compliance and working with external CROs in a regulated environment.