ABOUT THE FLOCK

Join bluebird bio’s enthusiastic and collaborative Quality Science and Technology (QSAT) team and in Quality Control as we continue on our mission of bringing out life-changing, novel gene therapies to patients! We are looking for an energetic and goal-oriented candidate to join our QSAT team, overseeing QC analytical methods for bluebird bio’s autologous cellular drug products in our late stage and commercial gene therapies. In your role, you will be responsible for managing and supporting all activities associated with analytical method lifecycle, such as method validation, method transfer, method investigation and remediation, and method implementation of in-process and release tests across the associated CxO network (Contract Testing Organizations and Contract Manufacturing Organizations.

HOW YOU’LL FLY

You'll help to bring more patients their bluebird days by: 

• Designing and overseeing QC laboratory studies performed for validation and/or remediation of QC methods used for inprocess, release, and stability testing of our autologous cellular drug products
• Authoring and review of method lifecycle documents such as protocols, reports, test methods, SOPs, and risk assessments required for the maintenance of the lifecycle for lot release and stability methods used by the QC unit.
• Analyzing data generated during method lifecycle activities using statistical software and/or Microsoft Excel.
• Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results.
• Participating in method monitoring of bioassay, molecular, and/or cell-based methods to support QC method lifecycle.
• Tracking project status and communicating to cross-functional teams including QC, CMC, and Quality.

WHAT YOU’LL BRING

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

• Bachelor’s or Master’s degree in Biology, Biochemistry, or related scientific discipline.
• A minimum of five (5) years of related experience in a QC GMP environment with late-stage clinical (Phase II, III) or commercial setting; commercial experience a plus.
• Experience with development, qualification, and validation of QC test methods (i.e. cell-based assay, flow cytometry, potency assay, and/or cell culture experience is desirable).
• Experience with owning quality system records required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results
• Good understanding of or proficiency with statistical software packages, such as JMP or Prism

Contract Length: 12 months

Location: U.S. Remote - East / Central Time.