Senior Manufacturing Associate / Manufacturing Associate
Fate Therapeutics is seeking an experienced and highly motivated manufacturing technician to join our manufacturing team to support operation of the cGMP clean room suite in a variety of production activities related to Fates cell therapy clinical trials. The successful candidate will develop and adhere to written procedures (SOPs) related to housekeeping, monitoring of equipment and facilities, and manufacturing of cell therapies internally at Fate. This person demonstrates cGMP compliance and support for manufacturing activities across multiple programs. This is a full-time position initially reporting to the Associate Director, Manufacturing, and is located at our corporate headquarters in San Diego, CA.
- Assists in setting up manufacturing areas and equipment/fixtures. Performs facility and equipment monitoring activities.
- Writes manufacturing operating procedures that are technically sound, promotes effective and efficient operations, and complies with cGMP requirements.
- Performs manufacturing and support operations described in standard operating procedures and batch records.
- Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
- Completes training assignments to ensure the necessary technical skills and knowledge.
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
- Minimum 2 years of experience in cGMP biologics cell culture manufacturing, experience in biotech or cell therapy manufacturing preferred.
- Experience in the following preferred: o Aseptic processing in ISO 5 biosafety cabinets. o Universal precautions for handling human derived materials in BSL-2 containment areas. o Cell expansion using incubators and single use bioreactors. o Cell washing processes and automated equipment. o Cell separation techniques and automated equipment. o Cryopreservation processes and equipment.
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Working Conditions and Physical Requirements:
- Will require working with cells and cell lines
- Will require working with hazardous materials
- 100% on-site work at corporate headquarters in San Diego, CA
- Evening and weekend work as necessary
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.
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). The Company’s pipeline also includes ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease in patients with hematologic malignancies undergoing allogeneic stem cell transplant. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.