Sr Associate Scientist II / Scientist I, QC Method Validation (468)

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 professional to support qualification and validation of analytical methods for the Quality Control release and stability testing, in support of the late stage clinical trials and eventual product commercialization of gene therapy products. The candidate will interface with Analytical Development and Process Development for method qualification and validation activities, and to develop validation strategies and timelines. A strong technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role. This position may require travel and hands on laboratory time.

About the Role:

  • Collaborate internally and externally to manage test method qualification, transfer, validation
  • Author, review and approve phase-appropriate test method validation protocols and reports
  • Lead the implementation of test methods at external manufacturing organizations and contract laboratories by overseeing the qualification and validation activities as well as critically assessing laboratory readiness and capabilities.
  • Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements
  • Support of cGMP operations, including technical review of change controls, corrective actions/preventative actions , deviations, OOS and other investigations or assay troubleshooting
  • May plan and execute laboratory experiments with general guidance
  • Assist in the writing and review of standard operating procedures (SOPs) and Quality Control policies
  • Support the generation, characterization, and maintenance of reference standards for analytical methods and bioassays

About You:

  • BS with 6+ years or MS with 3+ years in a biotechnology discipline
  • 3+ years of experience in a GMP/GxP environment is preferred
  • Hands on experience in qualifying and validating flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC methods
  • 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 test methods and 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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