Fate Therapeutics is seeking an experienced and highly motivated manufacturing supervisor 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 reporting to the Senior Manager, Manufacturing, and is located at our corporate headquarters in San Diego, CA.
- Accountable for the daily operations in the manufacturing area, responsible for supervising all activities in the assigned work area to ensure manufacturing goals are met while maintaining compliance with cGMP and EHS guidelines.
- Assures team members are trained and understand duties and responsibilities.
- Coordinates day to day activities collaborating with cross functional teams.
- Writes manufacturing operating procedures that are technically sound, promotes effective and efficient operations, and complies with cGMP requirements.
- Communicates to manufacturing team daily while maintaining a constant floor presence.
- Reviews and approves 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.
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
- Minimum of 2 years of experience supervising or managing a team in cGMP biologics cell culture commercial manufacturing.
- Minimum of 5 years of manufacturing experience, preferably in biotech.
- Key leadership attributes including: o Fosters collaboration and teamwork. o Champions change. o Leads with integrity and respect. o Coaches and develops. o Promotes a positive work environment.
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.