$80K — $100K *
Description 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 scaledown 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
• Experience in cell therapy R&D desired, preferably with NK, T-cell and/or pluripotent cell
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 incident
Valid through: 8/13/2020