StLouis, mo; san diego, ca; or remote work eligible
Wugen, incIs a clinical-stage biotechnology company developing novel “off-the-shelf” memory nk and car-t cell therapies for the treatment of cancerOur immuno-oncology therapies address the unmet need of patients with solid tumors and hematologic malignanciesOur transformative platform provides a distinct set of advantages over other immune cells commonly used for cell therapyWe have premier research facilities in stLouis, mo and san diego, caCome join us in our pursuit to eradicate cancer.
Job description
Wugen incIs seeking exceptional and highly motivated candidates to join our growing cmc team to be based in stLouis mo or san diego caThis 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 filingsThe compensation package will be competitive and commensurate with experience and the specific level of the candidate.
Primary responsibilities
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.
Preferred qualifications
Degree in biology, engineering, or related field7+ 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.
