Quality Control CMC Lead

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 quality professional to represent QC across the various drug candidate teams. This role will help integrate the needs of each candidate team within the short and long-term operational goals of QC groups and functions (analytical method lifecycle, release/stability testing, systems implementation, regulatory support). The ideal candidate will have experience both within biopharma QC and project management. The role will not just track timelines, but will be responsible for offering solutions, maintaining strategic alignment across programs, identifying and ensuring awareness of resource constraints.

About the Role:

  • Represent QC on drug candidate and commercial CMC teams
  • Routinely present status updates to internal and external customers to maintain cross-quality alignment
  • Manage QC timelines across programs and program-specific integrated timelines
  • Maintain cross-project visibility for QC department
  • Help identify resource constraints and offer solutions before conflicts arise
  • Coordinate activities with internal (cross department) and external (CTO) stakeholders
  • Participate in new initiatives and systems implementations (paper and electronic) across sites

About You:

  • BS or MS in a scientific discipline, 8+ years of related experience in QC GMP environment in a clinical and/or commercial environment
  • Project Management skills and a strong understanding of risk management and risk tolerance
  • Strong track record of interpreting cGMP/ICH/FDA/EU regulations
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders (internal and external)
  • 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 can work with limited direction in a risk tolerant, fast-paced, innovative environment
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
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bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

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