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Senior Analyst I

Company: bluebird bio
Location: Somerville
Posted on: January 27, 2023

Job Description:

ABOUT THE FLOCK
Join bluebird bio's enthusiastic and collaborative Quality Science and Technology (QSAT) team in Quality Control organization to contribute to the overall success of our novel gene therapies. As a Senior Analyst I reporting to the Manager in Quality Control, you will manage and/or support contract testing organizations and contract manufacturers for bluebird bio starting/raw materials and lentiviral vectors for our late stage and commercial gene therapy products. This includes managing and supporting all activities associated with method lifecycle activities such as method qualification/validation, method transfer, method remediation and reagent qualification at the associated CxO(s).
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days by:


  • Managing Quality Control activities related to starting/raw materials and lentiviral vectors method lifecycle and communications within CTOs and CMOs
  • Authoring and/or supporting approval of internal and external protocols, reports, SOP's, and technical assessments in support of starting/raw materials and lentiviral vectors method lifecycle activities at bluebird bio's network of QC laboratories
  • Owning quality systems required for change controls, deviations, laboratory investigations, CAPAs and out-of-specification (OOS) related to method implementation or method performance
  • Managing activities required for method lifecycle including coordination of sample shipment, submitting legal contracts, and owning POs
  • Supporting method monitoring focused on assessment of method performance
  • Ensuring all documentation comply with cGMP regulations and industry guidelines

    WHAT YOU'LL BRING
    You're the bird we're looking for if you have:

    • BS and 5+ or MS and 3+ years of related experience in a GMP/GxP clinical and/or commercial environment
    • Experience with development, qualification, validation of analytical methods
    • 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
    • Proficiency with Microsoft Word, Excel, and PowerPoint
    • Superb organizational, analytical, and communications skills
    • An exceptional attention to detail

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

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