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 Wugen’s allogeneic CAR-T program. The compensation package will be competitive and commensurate with experience and the specific level of the candidate.
- Oversee clinical manufacturing at an external CDMO.
- Coordinate scheduling, shipping, and testing of drug product.
- Investigate deviations and work with quality and regulatory to determine lot disposition.
- Oversee clinical lot release testing at external CROs.
- Oversee process optimization and scale up activities.
- Manage internal team of scientists.
- Outsource additional optimization and scale up activities at a CDMO.
- Transfer CAR-T manufacturing to a partner in China.
- Coordinate with outsourcing, MSAT, regulatory, and clinical teams to ensure Wugen’s drug product supply and regulatory needs are met.
- Degree in biology, engineering, or related field. 15+ years experience with a BS, 12+ years with an MS, or 8+ years with a PhD.
- 5+ years management experience.
- Cell therapy development, including design of experiments.
- T-cell culture experience, and knowledge of aseptic technique, GxP, automated culturing systems (e.g., CliniMACS Prodigy).
- Flow cytometry and cell-based assay qualification/validation experience preferred.
- 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.