Director, Cell Process Development

Cambridge, MA

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approaches. bluebird bio seeks an experienced professional to lead the cellular drug product process development function. In this role you will have a leadership position within the process and analytical development organization that encompasses both lentiviral vector and cell processing operations for oncology and severe genetic diseases. The position is ideally suited for a professional with passion for and a proven track record of exceptional talent development and organizational leadership. There is great opportunity to lead and evolve this function to support a broad portfolio and advance the manufacturing capabilities to scale-out autologous cell-based processes to deliver therapies that transform the lives of patients.

Responsibilities:

  • Develop and mentor a high-performance team of scientists and engineers with a vision of setting industry-leading scientific standards in drug product process development for autologous cell-based gene therapies
  • Develop the strategy to evolve the drug product development function for late-stage products and rapid transition of early-stage candidates into the clinic
  • Drive the continued development of robust, cost-effective, scalable autologous cell-based drug product manufacturing processes for hematopoietic stem cell and T-cell products
  • Identify risks and drive continuous improvement through technological innovation and alignment with regulatory and commercial manufacturing requirements
  • Apply biologics development and continuous/automated manufacturing concepts, tools, and practices while driving to re-define how they are applied in this novel and growing field
  • Support the interface between other Research, CMC, Quality, Regulatory, Clinical, and Program Management functions to align the functional strategy with peer dependencies and with program, portfolio, and corporate goals
  • Build processes and relationships with external and internal development and manufacturing organizations
  • Ensure compliance to regulatory requirements, and quality systems in a GMP environment
  • Support regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filings

Qualifications

  • A PhD in the pertinent life sciences or engineering, with 10+ years relevant industry/academic experience
  • Experience managing scientists and engineers in a research, process development or manufacturing organization is required
  • Demonstrated ability to drive technological innovation and implementation in a clinical or commercial manufacturing environment is required
  • Prior experience in the cell or gene therapy field is a plus
  • A keen ability to build an organization, interface with stakeholders, and help manage the dynamics of change within a rapidly growing company
  • 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
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
  • Above all else, an absolute passion for addressing the critical unmet needs of patients.
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