Job Summary :

Sangamo Therapeutics is seeking a Process Development Engineer, who will be responsible for the design, execution, analysis, and communication of cell therapy process development activities. The candidate will contribute to the development of a robust and consistent cell manufacturing processes, in accordance with manufacturing and cGMP requirements. This role requires a good understanding of cell therapy manufacturing process and its impact on the function and activity of cell quality attributes. This role also involves working at the bench at laboratory scale to evaluate critical process parameters influencing cell isolation, expansion, purification, transduction/transfection and cryopreservation unit operations related to yield and quality. Activities will also integrate scale-up of developed process and participation to GMP transposition in Manufacturing facility.

The candidate will be able to conduct and analyze flow cytometry assays and cell count and viability assays, working closely with Analytical department, to support process development activities.

Essential Functions :

• Lead in design, development, analysis and execution of manufacturing processes for cell therapy products as subject matter expert
• Identify and implement relevant up to date technologies for successful manufacturing of cell therapy products
• Provide process expertise in at least one of the areas of cell isolation, expansion, purification, transduction/transfection, cryopreservation
• Familiar to statistical tools and DOE approach to support process development
• Conduct/Analyze in process controls to support process development activities (mainly phenotypic analysis, cellular assays that indicate cell functionality)
• Lead, review and/or assist in writing and revising technical documents including laboratory SOPs, study protocols and reports
• Collaborate with Analytical Development, Research, MSAT, Manufacturing and Quality as well as external partners to design,
• Participate to the implementation of GMP-compliant cell therapy manufacturing process.
• Provide Subject Matter Expertise during Tech Transfer to internal or external manufacturing teams and provide training and technical support.
• As SME and in collaboration with MSAT/QA, support complex deviation investigations to ensure timely resolution and support GMP batch release
• Manage and develop direct reports 

Education, Experience and skills requirements :

• Ph.D. or M.Sc  or Engineer degree in Immunology, BioChemical Engineering, Cell Biology, Biological Sciences, or Biochemistry, or related life science disciplines with 5+ years industry experience.
• Experience in process development of mammalian cell lines or primary cells, preferable within the field of cell and gene therapy in the biopharmaceutical industry
• Preferable experience in manufacturing of cellular therapies including cell separation, cell processing, gene editing, and cell culture techniques for primary cells. Experience with cell base assays, immunoassays, FACS analysis & practices is a real “plus”,
• Must have a solid understanding of process development activities from early stage up to technology transfer. Including knowledge of the relevant regulatory guidelines regarding process development
• Good statistical and DoE knowledge used in process development
• Relevant skills include experience with management of small teams and lab workers
• Excellent written and oral communication skills. Ability to acquire knowledge quickly.
• Ability to work independently and to participate in cross-functional teams, meet deadlines, and organize and prioritize work