Quality Control Lead Analyst

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek a quality control professional with experience leading analytical and bioanalytical validations as well as strategically leading lifecycle management of quality control methods. The methods will be implemented and maintained to support release and stability testing of materials related to late stage clinical trials and eventual product commercialization. The candidate will interface with Analytical Development and Process Development for method qualification and validation activities. The candidate will interface with Regulatory Affairs and Senior Quality management to develop validation strategies and timelines. A strong technical background in cell biology, biochemistry, and molecular biology will be utilized in the role. This position may require some hands on laboratory time.

About the Role:

  • Collaborate internally and externally to manage test method transfer, assay validation and troubleshooting
  • Author, review and approve phase-appropriate test method validation protocols and reports
  • Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements
  • Support of cGMP operations, including technical review of change control documentation and reports, deviations, OOS and other investigations
  • Lead laboratory experiments both internally and externally with general guidance
  • Lead the review of internal SOPs/policies to align with industry standards
  • Lead the implementation of a references standard program for analytical methods and bioassays

About You:

  • BS with 10+ years or MS with 5+ years in a biotechnology discipline
  • 5+ years of experience in a GMP/GxP environment is preferred
  • Supervisory experience designing and overseeing the execution of laboratory experiments
  • Direct involvement with ensuring lab experiments are conducted to meet established timelines
  • Proficient at technical writing of protocols and reports for method validation
  • Experience with statistical analyses for evaluation method performance and justifying product release specifications
  • Demonstrate a strong initiative and scientific leadership
  • Direct experience in authoring and review/approval of SOPs
  • Knowledge of designing analytical method qualifications and validations in accordance with cGMP/ICH/FDA/EU regulations
  • 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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