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Senior Analyst II

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

Job Description:

Come join bluebird bio's enthusiastic and collaborative Quality Science and Technology (QSAT) team in Quality Control as we continue on our mission of bringing our life-changing, novel gene therapies to patients! As a Senior Analyst II, you will manage and/or support analytical method lifecycle management activities for bluebird bio's cellular drug products in our late stage and commercial gene therapies. You will be responsible for managing and supporting all activities associated with method lifecycle, such as method validation, method transfer, method remediation, and method implementation of in-process and release tests across the associated CxO network (Contract Testing Organizations and Contract Manufacturing Organizations).
You'll help to bring more patients their bluebird days by:

  • Manage Quality Control related communications within CTOs and CMOs
  • Design and oversee external QC laboratory studies performed for validation and/or remediation of QC methods used for in-process, release, and stability testing
  • Author and/or review of method lifecycle documents such as protocols, reports, Test Methods, SOPs
  • Own quality systems required for change controls, deviations, laboratory investigations, CAPAs and out-of-specification (OOS) related to method implementation or method performance
  • Own and/or support cGMP routine testing by owning quality systems required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results
  • Manage activities required for method transfer and validation including coordination of sample shipment, submitting legal contracts, and owning POs
  • Ensure all documentation complies with cGMP regulations and industry guidelines.

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

    • BS or MS in a scientific discipline, 3-5+ years of related experience in QC GMP environment in a clinical and/or commercial environment
    • Experience in cell-based bioassays (such as potency assays), molecular biology (such as qPCR), ELISA, and/or biochemistry
    • Strong track record of interpreting cGMP/ICH/FDA/EU regulations
    • Experience with and good understanding of statistical software packages such as JMP

Keywords: bluebird bio, Somerville , Senior Analyst II, Professions , Somerville, Massachusetts

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