Start up in the RTP is seeking a Director of Bioprocess to build and lead our Bioprocess team. Core parts of the role include developing and optimizing mammalian/avian seed trains, scaling-up/scaling-out GMP-compliant bioreactor systems and enabling large-scale cell/tissue harvesting.

typical roles and responsibilities for Senior Director of Bioprocess

Reporting to the CTO, the Senior Director of Bioprocess will build and lead the bioprocess team, with an initial focus on designing and operationalizing a process for pilot manufacturing systems, including, but not limited to, the following activities:

  • Build and lead a team of industry-experienced bioprocess scientists/engineers
  • Serve as point person for internal bioreactor tech transfer from our R&D team
  • Refine design, scale-up, and coordinate fabrication of our proprietary bioreactor
    prototype into a validated, GMP-compliant bioreactor module, including design and
    integration of process monitoring and control systems
  • Design and coordinate execution of bioprocess optimization and cost-of-goods reduction studies, including biomass yield optimization, culture media usage optimization, media recycling, and evaluation of media feed strategies.
  • Coordinate the drafting of GMP production documentation, including SOPs and batch records with our Director of Quality
  • Coordinate and execute the internal tech transfer of the GMP production bioprocess to the pilot manufacturing team
  • Develop next generation GMP bioreactor systems and further bioprocess optimization and COGs reduction

Requirements for Director Senior Director of Bioprocess – Scientific

  • PhD or MS in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, or another relevant engineering discipline
  • 10+ years of industrial experience in upstream mammalian bioprocess scale-up and optimization
  • 5+ years of industrial leadership experience
  • Deep and broad experience implementing GMP and QbD in bioprocesses
  • Demonstrated expertise in mammalian seed train development
  • Demonstrated expertise in designing and coordinating the fabrication of GMP-compliant
    mammalian cell bioreactor systems
  • Experience in GMP facility build-out, including, but not limited to, drafting of Functional Requirements Specifications, Detailed Design Specifications, and Process and Instrumentation Diagrams, clean rooms, sterilization and cleaning infrastructure, culture media and buffer preparation from powdered media
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