Fate Therapeutics is seeking Senior Manufacturing Associate/Lead: Aseptic Cell Culture to join our Manufacturing team. This position will require a subject matter expert/lead for well-regulated GMP aseptic cell culture activities including media preparation, cell thaws, cell expansion, cell differentiation, and cell harvests using standard, well understood cell culture technologies in a cleanroom environment. Will also perform verifier activities during the process. Will be responsible for the accurate and timely performance and documentation of work performed. This is a full-time exempt position reporting to the Manufacturing Supervisors/Managers and will be located at our corporate headquarters in San Diego, CA or Torrey Pines Location.Responsibilities
- Responsible for the execution of cell culture manufacturing activities of iPSC based Drug Product from thaw of MCB's through harvested cryopreservation and quarantine of Drug Product
- Responsible for scheduling manufacturing activities and staff
- Responsible for accurate documentation of manufacturing activities
- Responsible for documenting and investigating manufacturing related deviations
- Engage with supply chain and materials management to assure adequate inventory of raw materials to support planned production activities
- Maintain cGMP training requirements
- Support a positive and engaged work environment for manufacturing personnel.
- Develop personnel schedules to allow effective execution of manufacturing activities.
- Develop and maintain professional relationships with partner groups including Quality Assurance, Supply Chain, Quality Control, MSAT, Process Development, Clinical, and Facilities.
Working Conditions and Physical Requirements
- A High School diploma is required. An Associate or Bachelor's degree in a relevant discipline highly preferred
- 5 years technical experience in the GMP Manufacturing area for Drug Products produced by aseptic cell culture.
- The ability to create, read, review, and edit manufacturing related documents including batch records, SOP's, and forms
- The ability to collect, compile and analyze a variety of data, and use to draw conclusions
- Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced & dynamic environment.
- Experience in iPSC or hESC drug product manufacturing is preferred.
- Familiarity with standard cell culture methods is preferred.
- Primarily on-site work at one location in San Diego, CA with some travel between locations
- Occasional evening and weekend work will be required.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit .