Senior Technology Transfer Specialist, Process Sciences
Fate is currently seeking a motivated technical leader to join our Process Sciences team, to facilitate technology transfer of novel iPSC-derived immunotherapy production processes to manufacturing facilities. The successful candidate will partner with functional groups - including manufacturing, process sciences, development, and quality teams - to execute technology transfer plans in support of Fate iPSC product pipeline. The position will be responsible for drafting manufacturing batch records, performing reviews of documentation, compiling process descriptions and flow diagrams, training new manufacturing facilities, and performing analysis of product lots for clinical trials. The successful candidate will have excellent organization and communication skills, a keen attention to detail and thrive in a team environment. This is a full-time position reporting to the Associate Director of Process and Assay Development and is located at our corporate headquarters in San Diego, California.
- Develop and execute plans for iPSC-derived hematopoietic product manufacturing process and assay technology transfer to clinical manufacturing facilities.
- Provide technical support to clinical manufacturing facilities via phone, e-mail, and/or on‑site visits, as necessary. This includes training, oversite of manufacturing activities, and troubleshooting efforts.
- Help to manage product-specific supply chain for clinical manufacturing facilities.
- Draft batch records and SOPs, and facilitate the manufacturing document review prior to implementation.
- Partner with functional teams to identify essential process improvement aims and ensure successful implementation of process changes across manufacturing facilities.
- Author, review, and/or edit technical documents to support regulatory filings, including reports, INDs, and amendments.
- Review clinical batch production records and continually assess manufacturing process data to expand process understanding.
- B.S. / M.S. / Ph.D. degree in Biological sciences or equivalent scientific discipline.
- Minimum 7 years of related experience in a clinical-stage biotech or pharmaceutical company.
- At least one year of cell therapy experience strongly preferred.
- Must work well in a team environment with admirable interpersonal and communication skills (written and verbal).
- Experience working with contract manufacturing facilities, providing technical support, as well as training.
- Must be highly organized, detail oriented and have strong analytical and problem-solving skills.
- Experience with stem cell biology, developmental biology and/or immunology strongly preferred.
- Experience using sterile technique, cell culture or other related experience.
- Working knowledge of cGMPs, GTPs and GCPs.
- Experience writing study protocols, executing experiments, drafting study reports and batch records.
Working Conditions and Physical Requirements
- Will require working with cells and cell lines of human and/or animal origin
- Will require working with hazardous materials
- 100% on-site work at corporate headquarters in San Diego, CA
- Evening and weekend work as necessary
- Requires occasional travel
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.
For consideration send cover letter and resume to: email@example.com and reference job code 215BR.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company is pioneering the development of off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.