Director of Manufacturing
Stratacuity
FR
il y a 13h

Job Scope & Purpose :

Our exceptional small, privately owned and clinical stage Greater Boston area client, developing novel delivery approaches to cell therapy (via a device platform, is seeking a dynamic leader to manage all aspects of manufacturing.

This individual will focus on overseeing external partners (CMOs) producing cells (drug substance) and focusing on a biologic-

device combination (drug product). This leader will build and lead a dynamic team to drive process engineering for all manufacturing needs through to mid and late-

stage clinical trials and commercialization. Opportunities like this do not come along often so reach out to Todd Jamison and his team to learn more!

Primary Job Responsibilities :

  • Optimize current processes and develop a next-generation process focused on supplying cells and final product for future clinical and commercial efforts
  • Manage existing CMOs producing cell banks and expanding operations needed to supply clinical inventory
  • Manage external partners focused on the biologic-device combination
  • Build and lead a team dedicated to manufacturing and process engineering
  • Serve as a technical Subject Matter Expert on all manufacturing initiatives internally
  • Primary Job Requirements :

  • Degree in a relevant biologic or engineering discipline, with a minimum of 10 years’ industry experience
  • Must have significant experience in developing and managing FDA-regulated cellular GMP manufacturing
  • Previous supervisory and leadership experience is required
  • Relevant management experience in an FDA biologics regulated environment strongly preferred
  • Previous experience in the creation of, or significant contributions towards CMC sections of an IND and / or BLA
  • Ability to travel 10-20%
  • To Be Successful, an Ideal Candidate must have :

  • Strong roots in Cell Therapy / Biology the mechanical / automation foundation is based on an understanding of HOW cells react
  • Regulatory knowledge on requirements associated with combination products
  • Understanding what it takes to be successful in a small company
  • Creativity and confidence to find solutions to problems and be comfortable with ambiguity in a relatively new arena of development
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