Job Description
Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing MSAT team to be based in St. Louis, MO or San Diego, CA or remote. This candidate will be responsible supporting technology 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.
Primary Responsibilities
- Review and approve CMO master batch records
- Perform CMC review and approval of specifications, labels, protocols, technical reports, etc.
- Support person-in-plant observations, process gap and risk analysis, and preparation of Technical Transfer packages to facilitate cGMP manufacturing at CMOs
- Lead or support investigations related to manufacturing deviations
- 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
Preferred Qualifications
- MS in a scientific discipline (Biological Sciences, Biomedical/Chemical Engineering, or related) with 1+ years of relevant experience, or BS with 2+ years of relevant experience (industry experience preferred)
- Prior process development experience or technology transfer experience to a CMO
- GMP manufacturing or QC experience, batch record creation/review experience
- Cell and gene therapy experience is strongly preferred
- Hands-on experience with the CliniMACS Prodigy system (or other cell processing systems) and experience with formulation and cryopreservation
- Self-motivated with ability to work independently and operate effectively within an entrepreneurial fast-paced, collaborative work environment.
- Detail-oriented with strong organizational and communication skills
- JMP, flow cytometry, qPCR and cell-based assay, Veeva Vault experience considered a plus
- Strong knowledge in standard software including Word, Excel, PowerPoint, Teams and OneNote
