Quality Control Manager - Bioassay Validation

Cambridge, MA, United States
Dec 07, 2018
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced Quality professional with extensive experience with bioassay method implementation, validation, and lifecycle management. Specifically related to novel lentivector potency analyses using qPCR and flow cytometry methodology. The bioassays will support a wide variety of manufacturing process technical transfers as well as routine Quality Control operations. The manager will lead a growing team and should have a proven track record as a supervisor or manager in a fast-paced innovation driven setting. The role will interface with internal Quality Control, Analytical and Process Development, Manufacturing Sciences and Technology, and multiple Quality Assurance groups to ensure company procedures and industry guidelines are followed. A strong technical background, and proven track record in Quality Control, with methods related to viral advanced cell therapies, bioassay, cell biology, biochemistry, and molecular biology.

About the Role:
  • Collaborate internally and externally to manage a team focused on implementation and lifecycle management of bio-analytical, cell-based, and immunological-based assays
  • Additional collaboration responsibilities will focus on manufacturing process technical transfer, in-process testing strategy, analytical and process comparability assessments
  • Support or lead implementation of a assay monitoring program focused on proactive assessment of method performance, including reevaluation of system suitability requirements
  • Experience with statistical data analysis for method and process monitoring and reporting would be preferred
  • Support of cGMP operations, including technical review of change control documentation and reports, deviations, OOS and other manufacturing and laboratory investigations
  • Lead the review of internal SOPs/policies to align with industry standards related to analytical method and critical reagent lifecycle, including continued process verification for viral-based advanced therapy medicinal products
  • May manage 2+ direct reports and a team of 4+
  • This position may require travel (approximately 5%)

About You:
  • BS with 10+ years or MS with 8+ years in a biotechnology discipline in a GMP/GxP environment
  • 3+ years' experience with managing direct reports in an analytical or Quality Control laboratory
  • Knowledge of designing analytical method validations in accordance with USP/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 works 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