Sr. Scientist, Gene Editing Materials Process Development; temp

About Allogene:

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.

Job Description:

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.

Responsibilities include, but are not limited to:

• 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

Position Requirements &

Experience:

• 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)
• Direct experience developing, characterizing, scaling, or supporting GMP manufacturing processes for gene editing materials (e.g., mRNA, nucleases) and/or gene delivery materials (e.g., AAV, lentiviral vectors, non-viral delivery systems) is strongly preferred. Experience solely using these materials for gene editing applications without involvement in process development or manufacturing is unlikely to meet the requirements of this role.
• 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…