Principal Scientist, Bioanalytical Lead

About the position

The Principal Scientist, Bioanalytical Lead at Bristol-Myers Squibb is responsible for providing bioanalytical leadership for drug development programs, utilizing LC-MS technology. This role involves overseeing assay development, validation, and sample analysis, while ensuring high-quality data delivery to support regulatory filings and drug development processes. The position requires collaboration with internal teams and external partners, contributing to scientific literature, and representing bioanalysis on cross-functional teams.

Responsibilities

• Provide bioanalytical strategies related to BMS development compounds from GLP studies to life cycle management.
• Provide leadership for bioanalytical issues for BMS development candidates on project teams.
• Oversee assay development, validation, and performance monitoring at CROs, ensuring on-time, high-quality delivery of data and reports.
• Author and review regulatory filing documents (IND, NDA/BLA, IB, etc.) and interact with health authorities on BA-related inquiries.
• Represent regulated bioanalysis on cross-functional teams and contribute to process improvements.
• Act as LC-MS Technology lead on cross-functional teams for non-routine LC-MS BA analysis responsibilities.
• Enhance the scientific credibility of BMS through contributions to scientific literature and interactions with academic and health authorities.

Requirements

• Bachelor's Degree with 8+ years of academic and/or industry experience, or a Master's Degree with 6+ years, or a Ph.D. with 4+ years of experience in the Life Sciences.
• Demonstrated background in regulated LC-MS bioanalysis project management in a regulated organization (CRO or pharmaceutical company).
• Strong background in sample preparation, chromatographic separation, and mass spectrometric technology utilized in regulated bioanalysis.
• Thorough understanding of GxP regulations and ICH M10.
• Record of accomplishments in cross-functional leadership, scientific presentations, and time management.

Nice-to-haves

• PhD degree in a related field is preferred.
• Ability to multi-task and work in a collaborative team environment.
• Effective communication skills in a team-based environment.

Benefits

• Competitive salary
• Wide variety of competitive benefits, services, and programs to support employee goals.