Senior Scientist, Manufacturing Science and Technology

Location
San Diego, CA, United States
Posted
Sep 14, 2020
Ref
325RA
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Fate Therapeutics is seeking an experienced and highly motivated cell therapy process development professional to develop manufacturing processes for new cellular immunotherapeutic candidates. The successful candidate will work in a multidisciplinary science and technology team to define robust manufacturing processes and associated analytical systems, develop scalable, cGMP-compliant processes and documentation for the manufacturing of novel allogeneic cellular therapeutic products. This position requires prior experience with mammalian cell culture, process development for cellular therapies, assay development, and excellent technical, organizational, and interpersonal skills. This is a full-time position reporting to the Senior Director of Manufacturing Science and Technology, and is located at our corporate headquarters in San Diego, CA.

Responsibilities:
• Lead the development and scale-up of cellular immunotherapy processes and products according to Fate Therapeutics' clinical and commercial strategic objectives.
• Assist in the identification and evaluation of new equipment, technologies and scientific advancements to establish a state-of-the-art cell therapy manufacturing capability.
• Establish process critical and quality attributes during process scale-up and lead the development of scaled-down models to expedite the development of robust commercial manufacturing processes.
• Assist in the implementation of automated systems for cell culture, downstream processing and fill-finish.
• Utilize and develop analytical and statistical methods to enable process and product characterization during process scale-up.
• Collaborate with Process & Analytical Development and Quality Assurance to translate protocols and processes into formal manufacturing procedures and batch records.
• Lead the tech transfer of new processes to internal and external GMP facilities and act as a technical expert during subsequent manufacturing campaigns.
• Train and supervise members of the MSAT team to develop new processes, scaled-down models, analytical methods and production techniques.
• Effectively & efficiently communicate results internally and externally. Prepare data reports for internal use, regulatory filings, and scientific conferences.

Qualifications
• PhD in Immunology, Biology, Biochemistry, Biochemical Engineering or Bioengineering with minimum 4+ years, MS with 6+, or BS with 8+ years industry experience.
• Expertise with small- and large-scale mammalian cell culture, as well as excellent aseptic bioprocessing techniques.
• Expertise with closed-culture systems and cell processing equipment, including cell culture in bioreactors, downstream processing, and cryopreservation processes, is preferred.
• Previous experience with developing cellular characterization assays including techniques such as, multiple parameter flow cytometry, ELISA's, and molecular biology experience is preferred.
• Familiarity with automated systems and/or statistical tools to enable process scale-down and robustness evaluation is preferred.
• Demonstrated ability to work collaboratively with Program Leaders from all functional areas (i.e. Quality, Regulatory Affairs, Clinical, Research and Technical Operations) to achieve project objectives on schedule.
• Experience writing protocols, reports, procedures and batch records.
• Familiarity with Good Manufacturing Practices (cGMP) is preferred.
• Self-motivated with excellent time management, organizational, analytical, and problem-solving skills.
• Experience in cell therapy R&D desired, preferably with NK, T-cell and/or pluripotent cell therapies.

Working Conditions and Physical Requirements
• 90% on-site work at corporate headquarters in San Diego, CA. 10% travel possible during technology transfer activities
• Evening and weekend work as reasonable and necessary
• Will require working with cells and cell lines of human and/or animal origin
• Will require working with hazardous materials 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 curriculum vitae to: careers@fatetherapeutics.com and reference Job Code 325RA. About Fate Therapeutics: Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of firstin-class cellular immunotherapies for cancer and immune disorders. 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 immunooncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include 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, 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.