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 the Manufacturing Sciences and Technology (MSAT) function, primarily engaged in the transfer and implementation of Wugen’s cell therapy programs at contract manufacturing organizations (CMOs). This role will also support in-house Product Development, investigations, and regulatory filings. The compensation package will be competitive and commensurate with experience and the specific level of the candidate.
- Oversee the preparation of Technical Transfer packages to facilitate manufacturing at domestic and international CMOs.
- Review and approve CMO master batch records.
- Lead or support investigations related to manufacturing or analytical deviations.
- Perform CMC review and approval of specifications, labels, protocols, technical reports, etc. – as appropriate.
- Participate in audits of CMOs.
- Work closely with research and development to ensure smooth transfer from discovery through development and into manufacturing/QC.
- Write and/or review development protocols and reports.
- Support IND activities, including authoring, reviewing, and data verification of appropriate sections.
- Build an MSAT team, as needed.
- Degree in biology, engineering, or related field. 7+ years industry experience with a PhD, 9+ years with an MS, or 12+ years with a BS; industry experience strongly preferred.
- Gene and cell therapy manufacturing, with GMP manufacturing or QC experience.
- Technical transfer experience to a CMO and batch record creation/review.
- Experience culturing T cells and NK cells.
- Hands on experience with the CliniMACS Prodigy system, and experience with formulation and cryopreservation in a controlled rate freezer.
- Statistical analysis proficiency for data analysis.
- Flow cytometry, qPCR, and cell-based assay experience considered a plus.