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Senior Manager, Stability

Company: bluebird bio
Location: Somerville
Posted on: January 26, 2023

Job Description:

This is a hands-on leadership role within our Quality Control stability team. We are looking for an experienced Quality Control professional to lead activities associated with QC strategic management of stability programs for ancillary materials, starting materials ,and drug products in support of our early and late-phase clinical and commercial development to ensure successful clinical and commercial regulatory filings in the US. You will provide significant contribution to the daily operations of the Quality Control, and partner with various internal laboratory operations as well as a Contract Testing Organizations (CTO) network.
You'll help to bring more patients their bluebird days by:

  • Contributing to the operation of stability programs across a multi-product portfolio
  • Originating ICH compliant stability plans, protocols, and reports; coordinate, review, trend, and report stability test data for drug product
  • Overseeing the maintenance of stability sample inventory, performance of stability sample pulls, and sample submissions to test laboratories
  • Managing and documenting stability test schedules and tracking of pending data for the purpose of maintaining performance of program metrics
  • Collecting raw data from test labs, performing cGMP data review, collating and archiving; utilizing statistical software to trend analytical data associated with stability testing
  • Leading and/or collaborating with Quality, internal functional areas, and/or CxOs, to review and perform documentation of deviations, CAPAs and OOS/OOT investigation reports
  • Providing data verification for CMC stability section of regulatory filings.

    You're the bird we're looking for if you have:

    • Bachelor's degree in a scientific discipline, 5+ years of related experience in a QC GMP environment
    • Strong knowledge of cGMP/ICH/FDA/EU stability regulations
    • Solid understanding of statistical analysis as it relates to product stability trending and establishment of shelf life
    • Experience and strong understanding of statistical software packages such as JMP
    • Ability to foster open communication, and facilitate mutual understanding and cooperation across various teams
    • Ability to navigate and be successful in fast-paced and highly-matrixed work environment with changing priorities
    • Experience with CTO/CMO management and strong interpersonal skills with the ability to motivate others, influence, and negotiate challenging situations

Keywords: bluebird bio, Somerville , Senior Manager, Stability, Executive , Somerville, Massachusetts

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