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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Senior Scientist, Method Development (Regulated Bioanalysis) - Method Development, Regulated Bioanalysis

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timePrinceton, NJ, USAIn-person

About the Job

Requirements

  • A Ph.D. or equivalent advanced degree in the Life Sciences is required.
  • At least 2 years of academic and/or industry experience is stated, and a separate qualification lists at least 4 years of academic and/or industry experience.
  • A preferred candidate will have a degree in Chemistry, Biochemistry, Biology, or a related field, plus relevant drug-development experience at a pharmaceutical company or a bioanalytical and biomarker contract research organization.
  • A good understanding of bioanalysis and biomarkers and their roles in drug development, including method development, validation, study support, and the impact of quality bioanalytical or biomarker data on pharmacokinetic/pharmacodynamic correlation, is required.
  • Strong liquid chromatography–tandem mass spectrometry skills are required, including separation and quantitation or identification of small- or large-molecule therapeutics and biomarkers in biological matrices.
  • Experience performing liquid chromatography–tandem mass spectrometry and ligand-binding assay method development, qualification and validation, and study-sample analysis in a regulated environment to support compliant preclinical and clinical studies is required.
  • A proven track record of method-development accomplishments in the field, demonstrated through presentations or publications, is required.
  • Experience authoring and reviewing bioanalytical and biomarker assays, troubleshooting assay issues, and directing junior scientists is required.
  • The candidate must be able to multitask and work collaboratively in a team environment.
  • The candidate must be able to communicate effectively in a team-based environment.

Responsibilities

  • Evaluate and implement bioanalytical methods during development.
  • Provide leadership on bioanalytical and biomarker method development, validation, and study support for development compounds across modalities, primarily using liquid chromatography–mass spectrometry technology.
  • Evaluate advanced laboratory equipment as a subject-matter expert.
  • Act as a bioanalytical or biomarker lead on cross-functional study teams and work with them to address related issues.
  • Evaluate and apply novel techniques or approaches to address challenging bioanalytical and biomarker issues.
  • Conduct in-house bioanalytical and biomarker support for development programs, including tandem mass spectrometry-based method development, validation, sample analysis, data interpretation, and report preparation in a regulated laboratory.
  • Serve as the technical expert on sample cleanup, chromatography, mass spectrometric instrumentation, stability, and other method-related issues.
  • Interact with bioanalytical contract research organizations to address method-related issues and lead knowledge transfer of novel technologies.
  • Keep management apprised of project status and current scientific trends through written and oral summaries and presentations.

Desired Qualifications

  • A strong foundation and experience using, maintaining, and troubleshooting mass spectrometers is preferred.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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