Join a fast-paced startup based in St. Louis with the opportunity to help drive process development activities of novel therapies for treating rare diseases. The product development (PD) scientist/engineer role will focus on the transfer and implementation of Wugen-developed processes at contract manufacturing organizations (CMOs). This role will also support in-house PD research and developing/running analytical methods.
- Support manufacturing at an external CMO.
- Work closely with research and development to ensure smooth transfer from discovery through development and into manufacturing/QC.
- Support process development studies.
- Support the development and running of analytical methods.
- Write and/or review development protocols and reports.
- Support IND activities, including reviewing, data verification, and potentially authoring sections.
- Degree in engineering, biology, or related field. 5+ years experience with a BS, 3+ years with an MS, 1+ years with a PhD; 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.
- Good sterile technique in a biosafety cabinet, hands on experience with the CliniMACS Prodigy system, and experience with formulation and cryopreservation with a controlled rate freezer.
- Statistical analysis proficiency for data analysis.
- Flow cytometry, qPCR, and cell-based assay experience considered a plus.