Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing CMC team to be based in St. Louis, MO or San Diego, CA. This candidate will oversee process development activities related to our memory natural killer (mem NK) program and will play a vital role in the translation of our novel cell therapies into the clinic. The compensation package will be competitive and commensurate with experience and the specific level of the candidate.
- Oversee a team of scientists who are responsible for the design and execution of NK process development studies, optimization experiments, data analysis, and generation of development reports.
- Work closely with R&D to ensure smooth transfer from discovery to CMC.
- As clinical programs progress, oversee manufacturing process scale up.
- Support regulatory activities, including ownership of development-related IND and BLA sections.
- Support the transfer of manufacturing processes to external CDMOs/CROs.
- Degree in biology, engineering, or related field. 15+ years industry experience with a BS, 10+ years with an MS, or 8+ years with a PhD.
- 5+ years management experience.
- Cell therapy development, including design of experiments.
- NK cell culture experience, and knowledge of aseptic technique, GxP, automated culturing systems (e.g., CliniMACS Prodigy).
- Proficiency with statistical analysis software for experimental design and data analysis.
- Familiarity with technical transfers to a CDMOs/CROs and protocol creation/review.
- Experience authoring regulatory documents.