Head of Drug Product Manufacturing

Cambridge, MA

 

Lead and build out the consolidation of our novel Drug Product manufacturing operations

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approach. bluebird bio seeks an entrepreneurial manufacturing professional to drive the strategy for our late-stage and early-stage clinical development programs. This role encompasses leading our manufacturing operations group and is ideally suited for a professional with strong management experience leading and evolving this function to support a broad portfolio of therapies. We are interested in candidates with a proven track-record of successfully integrating activities and perspectives across functions to achieve our ultimate goal to deliver therapies that transform the lives of patients. 

About the role:

  • Apply manufacturing concepts, tools and practices while driving to re-define how they are applied in this novel and growing field.
  • Act as a first-line resource to manage the interface between other CMC, Quality, Regulatory, Clinical, and Program Management functions and to align the functional strategy with peer dependencies and with program, portfolio, and corporate goals.
  • Facilitate/lead tech transfers for early and late stage hematopoietic stem and CAR T cell clinical programs to/from CMOs and participate in the customer interface as required.
  • Develop and mentor a high-performing team with a vision of setting industry-leading standards in this nascent field.
  • Build processes and relationships with external and internal development and manufacturing organizations.
  • Identify risks and drive continuous improvement in the manufacturing process through technological innovation and alignment with regulatory and commercial manufacturing requirements.
  • Actively engage in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites. Implement/support business process for continuous improvements.
  • Drive functional compliance to regulatory requirements, and quality systems in a GMP environment.
  • Author, review, and approve CMC documentation for regulatory filings as well as attending pertinent regulatory meetings as the functional owner.
  • Travel 20-30%

About you:

  • A PhD in the pertinent life sciences or advanced degree, with 10+ year’s relevant industry experience.
  • Experience managing a broad organization as well as external manufacturing providers, partners, and or academic collaborations is required.
  • Prior experience in successfully managing manufacturing functions in the cell or gene therapy field is a plus.
  • Proven track-record of successfully integrating activities and perspectives across functions
  • Ability and track record of successfully managing biologics programs through late-stage clinical development is required.
  • Thorough working knowledge of cGMP manufacturing.
  • Technology transfer and extensive CMO experience is required.
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations.
  • Outstanding communication, analytical and organizational skills.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment.
  • A passion for addressing the critical unmet medical needs of patients.
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

 

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