Associate Director, Process Development
- Progressive cell therapy company near San Francisco is seeking a process development leader with advanced process development and process improvement skills that include experience with mammalian cell cultures, stirred tank bioreactors, scale-up, and exposure to the distinct challenges of cell therapy.
- Leadership will include directing and executing process development studies to enable tech transfer of scalable cell therapy processes. Will provide a strategic voice in project planning, assessments, and presentations in collaboration with senior management. Will support compilation of CMC sections of novel drug INDs. Will bring advanced industrialization and bioreactor skills as demonstrated in a proven ability to work both standardized and new projects with equal ease.
- In addition to upstream-to-downstream scale-up and tech transfer experience bridging PD with GMP and experience working with mammalian cells, stem cells, or primary (CAR T or NK) cell categories, we would especially welcome a process development leader who has a novel mindset motivated to address the unique challenges of cell therapy.
- This role will report to a technically seasoned senior director who promotes independence, yet is readily accessible to provide support and mentoring as needed.
- Though this is not a one-hundred percent in-lab position, the ideal process development associate director would nevertheless have “good hands” in the lab and would not be adverse to investing some time in the laboratory. This multi-faceted technical leadership role requires exceptional cross-functional communication skills, collaboration, and guidance skills.
- This would be an ideal opportunity for a process development leader who believes in the high potential of cell therapy and who wishes to build technical and leadership skills within a uniquely collaborative work culture.
- PhD in Bioengineering, Biomedical Engineering, Process Engineering, or other scientifically relevant areas with a number of years of industry experience in a process development management role. Or an MS with equivalent combination of scientific training and industry seasoning.
- Experience applying the principals of engineering relevant to cell biology including both small-scale /early development experience AND larger scale / downstream (>10L) bioreactor experience.
- Experience in scaleup and tech transfer and in suspension based-bioreactors for the culture of mammalian-cell growth for advancement of GMP manufacturing of biological products, ideally for cell therapy.
- Advanced DOE and QBD skills; proven multi-tasking, organizational, and troubleshooting skills.
- Advanced cross-functional collaboration skills and ability to communicate effectively and providing cogent reports and presentations to diverse audiences.
- Ability to meet the challenges of a fast paced highly collaborative team-based work culture.
(An extra plus would be knowledge of viral transduction principles and processes.)
TO APPLY: Send CV by using the BioSpace link or by emailing your CV directly to firstname.lastname@example.org using the following job code on subject line: AD/PD/CT.