Senior Scientist, Method Development (Regulated Bioanalysis) Full-time NEW

Senior Scientist, Method Development (Regulated Bioanalysis)

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The position will be responsible for evaluating and implementing bioanalytical methods in the development stage. The individual will provide leadership on the BA/biomarker method development, validation, and study support of development compounds from various modalities (small molecule, large molecule therapeutics, etc.) mainly using LC-MS technology. In addition, the candidate will play a critical role as an expert in the evaluation advanced laboratory equipment. There are also development opportunities to act as a BA or biomarker lead on cross-functional study teams, and work with them to address bioanalytical and biomarker-related issues.

Key Responsibilities

• Evaluate and apply novel techniques or approaches to address challenging bioanalytical and biomarker issues.
• Conduct in-house bioanalytical and biomarker support for development programs with tandem mass spectrometry-based method development, validation, sample analysis, data interpretation, to report preparation in a regulated laboratory.
• Be the technical expert on sample cleanup, chromatography, mass spectrometric instrumentation, stability, and other method related issues.
• Interact with bioanalytical CROs to address method related issues and provide leadership for the knowledge transfer of novel technologies.
• Keep management apprised of project status and current scientific trends using written and oral summaries, as well as presentations.

Qualifications & Experience

• Ph.D. or equivalent advanced degree in the Life Sciences
• 2+ of academic and / or industry experience
• 4+ of academic and / or industry experience
• Preferred candidate will have a degree in chemistry, biochemistry, biology or related fields, plus relevant drug development experience at either a pharmaceutical company or a bioanalytical & biomarker CRO.
• A good understanding of bioanalysis & biomarker and their roles in drug development, including method development, validation, study support, and impact of quality bioanalytical/biomarker data to PK/PD correlation.
• Strong LC-MS/MS skills with separation and quantitation (or identification) of small (e.g. chiral assays) or large molecule therapeutics (e.g. hybrid assays for ADCs) and biomarkers (e.g. small molecule/protein assays) in biological matrices. A strong foundation and experience in using, maintaining, and trouble-shooting mass spectrometers is preferred.
• Experiences in performing LC-MS/MS and LBA method development, qualification/validation, and study sample analysis in a regulated environment to support preclinical and clinical studies with compliance.
• A proven track record of method development accomplishments in the field (thru presentations or publications).
• Good communication skills and experience in authoring and reviewing bioanalytical & biomarker assay, troubleshooting assay issues and direct junior scientist.
• Ability to multi-task and work in a collaborative team environment.