Associate Director, Pharmaceutical Sciences Regulatory Strategy Lead

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 CMC regulatory activities toward commercialization of our gene therapy products. In this position, you will report to the Vice President of Process Development and play a highly visible role within the Pharmaceutical Sciences 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 a proven track record in process and product development, including CMC-based interactions with global Health Authorities. This is a great opportunity to lead in the matrix to deliver therapies that transform the lives of patients.

Responsibilities:

  • Provide strategic leadership for the authoring, review and approval of the CMC sections of major regulatory submissions and response to queries
  • Provide oversight for a CMC authoring scope that includes all aspects of the manufacturing process: starting materials, plasmids, lentiviral vector, autologous cells and cellular drug product
  • As a matrix leader, guide a high-performing team of scientists and engineers with a vision of setting industry-leading standards for autologous cell-based gene therapies
  • Identify technical gaps and risks and drive resolution within the relevant functional areas
  • Apply knowledge of biologics CMC while driving to re-define how they are applied in this novel and growing field
  • Support the interface between other CMC, Research, Quality, Regulatory, Clinical, and Program Management functions to align the functional strategy with peer dependencies and with program, portfolio, and corporate goals
  • Ensure compliance to regulatory requirements, and quality systems in a GMP environment

Qualifications:

  • A M.S. in pertinent life science or engineering, with 15+ years relevant industry experience. Equivalent combinations of education and industry experience will be considered.
  • Demonstrated excellence in process development and/or manufacturing support for late stage or commercial products
  • Experience managing scientists and engineers in a research, process development or manufacturing organization is required
  • Demonstrated expertise in authoring CMC sections of marketing authorisation applications (MAAs), biologics license applications (BLAs) or major post approval submissions for biologics drug substance and/or drug product
  • Experience in the cell or gene therapy field is a plus
  • 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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