The Treg Manufacturing QA and Operations Manager at the UCSF and HICTF and GMP Facility will be responsible for operations primarily for Suite B (Regulatory T cell / stimulated B cell manufacturing and minimally for Suite A (Allogeneic and Autologous Islet manufacturing), including QA activities for Ste-B.
Specific duties include Treg manufacturing source cell material acceptance, batch record review and release, final product label, SOP reviews and revisions, equipment maintenance and QC, supplier qualification, and shared reagent inspection and receipts. Will work on special projects, including process development for new cell therapy products.
The Treg QA and Operations Manager reports directly to the Facility Director Florinna Dekovic. Salary commensurate with experience.
The UCSF HICTF and GMP Facility is a multi-use cGMP cellular therapy manufacturing facility that manufactures several cell types for clinical trials across the country, in addition to cell products for standard of care here at UCSF.
The Human Islet and Cellular Transplant Facility (HICTF) - GMP Facility at the University of California, San Francisco comprise the manufacturing cleanrooms designed and managed specifically for the production of innovative cellular therapy (CT) products under the standards of both current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP). The CT products are used in the... treatment of human diseases in approved early phase IND (Investigation New Drug application) clinical trials.
The GMP Facility has a three-fold mission in service, research and in education.