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Senior Analyst I

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

Job Description:

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).
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

    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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