Career Opportunities

Head of Development: CAR-T

St. Louis, MO / San Diego, CA

Wugen, Inc. is a clinical-stage biotechnology company developing novel “off-the-shelf” Memory NK and CAR-T cell therapies for the treatment of cancer.  Our Immuno-oncology therapies address the unmet need of patients with solid tumors and hematologic malignancies. Our transformative platform provides a distinct set of advantages over other immune cells commonly used for cell therapy. We have premier research facilities in St. Louis, MO and San Diego, CA. Come join us in our pursuit to eradicate cancer. To learn more about us, please visit www.wugen.com and follow us on LinkedIn.

Job Description

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.

Primary Responsibilities

  • 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.

Preferred Qualifications

  • 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.

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