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Jobs · Information Technology · Washington

Principal Scientist, Analytical Science and Technology (ASAT), Cell Therapy

Bristol Myers Squibb · Seattle, WA · 3 wk ago
Information Technology$128k–$155k/yrFull-time

Position Summary

The Principal Scientist is a highly experienced subject matter expert responsible for leading method optimization, transfer, and validation in support of Cell Therapy analytical portfolio. Conceptualize and lead complex projects, provides strategic scientific and technical input to the programs and projects. Apply technical knowledge, regulatory requirements, and scientific principles to independently perform complex troubleshooting and problem solving. The Principal Scientist balances deep hands-on laboratory involvement with cross-functional leadership, mentoring, and external scientific engagement.

  • Subject matter expert in Cell Biology and/or Molecular Biology, leads method technical investigation, method optimization/remediations, method transfer and method validation in compliance with regulatory requirements.
  • Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
  • Conceptualize and independently lead complex projects, investigations, corrective actions and continuous improvement efforts. This includes the design and hands-on executions of laboratory experiments, evaluation of experimental data, identification of risks and impact.
  • Represent the department in product review boards, regulatory inspections (internal and external audits).
  • Own and author relevant analytical sections of regulatory submission and responses to health authority questions and requests.
  • Implement method lifecycle and method maintenance programs to support methods in support of viral vector and cell therapy drug products.
  • Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
  • Represent ASAT interest on cross functional/ cross-site teams and communicate and collaborate effectively.
  • Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for non-routine complex issues.
  • Perform other tasks as assigned.

    Qualifications

    • Specific Knowledge, Skills, Abilities:
      • Demonstrated advanced technical writing skills.
      • Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical.
      • Ability to work independently in a fast-paced matrix environment, meet deadlines, and prioritize work from multiple projects.
      • Track record of scientific productivity as evidenced by publications, presentations, or equivalent internal contributions.
      • Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.
    • Reporting Relationship:
      • Perform other tasks as assigned.

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