We are searching for a Director of Bioprocess Development for an exciting new biotech company working in mammalian cell culture. Our client is a venture backed Series A startup who’s leaders have decades of experience in cell biology, tissue engineering, and bioreactor design. The Director of Bioprocess Development will lead a team developing and optimizing mammalian / avian seed trains, scaling-up and scaling-out GMP-compliant bioreactor systems, and enabling large-scale cell / tissue harvesting.
Requirements for the Director of Bioprocess Development:
- 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 instrumentation diagrams, clean rooms, sterilization and cleaning infrastructure, culture media and buffer preparation from powdered media.
- A track record of accomplishment mentoring and developing process development teams
Responsibilities of the Director of Bioprocess Development:
- Build and lead a team of industry-experienced bioprocess scientists and engineers
- Lead internal bioreactor tech transfer from our R&D team
- Refine design, scale-up, and coordinate fabrication of 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.
- In collaboration with quality, coordinate the drafting of GMP production documentation, including SOPs and batch records
- 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
Occupational Category: 19-1029 Biological Scientists, All Other
: Please apply using the form or send your resume to Debbie Winkelbauer