Senior Scientist Method Development, Regulated Bioanalysis

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Senior Scientist, Method Development (Regulated Bioanalysis)

Please Note:  The position will be responsible for evaluating and implementing bioanalytical methods in the development stage.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.     

The Regulated Bioanalytical function within Precision Medicine, Bioanalytical & Translational Sciences is a centralized function for testing biological samples for Pharmacokinetics (PK), Biomarkers, and Immunogenicity assessments. The responsibilities of the groups include providing bioanalytical leadership on BMS drug development teams via scientific/technical expertise and strategic input; overseeing and/or performing assay development/validation, and sample analysis; supporting discovery studies for biotherapeutics and regulated and non-regulated bioanalysis for toxicology and clinical studies; and preparing appropriate documentation and/or interacting with health authorities on the BA portion of regulatory filings. The BA groups utilize both internal resources and external strategic partners to ensure on-time delivery of BA data to enable key decisions for the organization.

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.

Basic Qualifications:

• Ph.D. or equivalent advanced degree in the Life Sciences

2+ of academic and / or industry experience

Preferred Qualifications

• Ph.D. or equivalent advanced degree in the Life Sciences

            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 bioanalytic