Senior Scientist, Gene Editing Process Sciences

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

We are seeking a highly motivated, self-driven and collaborative individual to join the Process and Product Development organization. The successful candidate will serve as a technical lead working with internal teams and external CDMOs focused on development and continued improvement of the manufacturing processes of gene delivery and/or gene editing materials used in allogeneic cell therapies. This individual will provide technical leadership across the product lifecycle, from early-stage process development through late-stage process characterization, control strategy development and commercial manufacturing readiness to support BLA submission and commercialization. This position will also provide technical oversight to support the production and re-supply of gene delivery and gene editing materials, as appropriate. This position is based in South San Francisco.

• Serve as technical subject matter expertise supporting CDMOs to provide process and assay development expertise for gene editing and/or gene delivery materials
• Partner with internal and external R&D, External Manufacturing, MSAT, and Quality to ensure cross-functional alignment
• Contribute to process development, process characterization, control strategy development and PPQ planning activities
• Work with internal and external partners to assess impact to process and method change for gene editing and/or gene delivery materials
• Support planning, execution and troubleshooting deviations of Process Development and GMP runs at CDMOs
• Develop and execute experiments to assess impact of gene editing and/or gene delivery materials on CART production process
• Develop analytical assays and provide testing for gene editing and/or gene delivery materials, as needed
• Engage with broader Process and Product Development team to contribute to achievement of Department goals
• Other duties as assigned

• PhD in biological sciences, engineering or related discipline with 5+ years of relevant experience in gene editing or gene delivery related field required (or MS with 10+ years, BS with 12+ years of industry experience)
• Strong knowledge background and hands-on experience with process and analytical development or manufacturing of gene editing material and/or viral/non-viral gene delivery material are required
• Experience with applying Design of Experiments (DOE), statistical analysis, and data visualization tools (JMP, Spotfire, or equivalent) for process development or characterization studies
• Prior experience serving as technical support for internal and external teams to manage process development and manufacturing at CDMOs is a plus
• Familiarity with cGMP manufacturing and regulatory expectations for biologics gene editing material or cell therapy products is a plus
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• Ability to work independently and in a matrixed environment
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Ability to travel up to 10%
• Candidates must be authorized to work in the U.S
• This is a 1-year contract opportunity with the possibility of extension or contract-to-hire.