Senior Analyst, Quality Control

Cambridge, MA

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced QC Senior Analyst to support establishing new commercial-level in-house GMP testing laboratories to support release and stability for multiple stages of our gene therapy and immune oncology products. This includes performing analytical methods, data review and trending, implementation of GMP operational support systems ensuring a compliant Quality Control lab. The candidate will interface with Analytical Development and Method Validation in support of method qualification and validation activities ensuring successful method transfer and collaboration, Quality Assurance, IT, Facilities, and other cross-functional teams as required. A strong cGMP, operational and technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role. This position will require hands on laboratory time.

About the Role:

  • Perform cGMP analytical testing (bioassay, flow cytometry, qPCR, HPLC, and ELISA)
  • Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.
  • Author, review, and/or approve SOPs/policies and technical reports with general guidance
  • Lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required
  • Lead, author, perform, and/or review equipment validations with minimal guidance.
  • Implement, lead and/or support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
  • Execute phase-appropriate test method validation protocols as needed
  • Participate in providing the necessary information for regulatory filings and inspections.
  • Lead and support CAPA/Continuous Improvement Initiatives

 

About You:

  • BS with 7+ years or MS with 4+ years in a biotechnology discipline
  • 4+ years of experience in a cGMP/GxP environment is preferred
  • Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC methods
  • Demonstrate a strong initiative and scientific leadership
  • Direct experience in authoring and review/approval of SOPs
  • Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
  • A passion for addressing the critical unmet medical needs of patients
  • Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
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