Associate Director, Cellular Process Development, Immunotherapy

Location
Cambridge, MA, United States
Posted
Sep 20, 2018
Ref
1214717
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The Process and Analytical Development organization at bluebird bio encompasses lentiviral vector, gene editing, and cellular drug product processing for oncology and severe genetic diseases. The cellular process development team is responsible for developing cellular drug product processes and introducing new technologies for stem cell and T cell therapies.

In this role you will have a leadership position within the cellular process development group that encompasses lentiviral vector transduction, gene editing and cell culture process development for our engineered T cell processes. 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 oncology portfolio and advance the manufacturing capabilities to scale-out engineered T cell 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 engineered T cell therapies
  • Drive the continued development of robust, cost-effective, scalable autologous cell-based drug product manufacturing processes for engineered T cell products
  • Identify and bring in new technology to improve the therapeutic potential of engineered T cells for cellular immunotherapy.
  • Support the interface between other Research, CMC, Quality and Regulatory 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 7+ years relevant industry experience (or MS with 10+ years) is required
  • 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 immunotherapy or gene therapy field is preferred.
  • 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