Sr. Scientist, Gene Editing Materials Process Development(temp)

Allogene Therapeutics•South San Francisco, CA

3d•Remote

About The Position

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 can be remote with some travel to San Francisco and various CDMO sites.

Requirements

PhD in biological sciences, engineering or related discipline with 5+ years of relevant experience in process development for the manufacturing of gene and cell therapy or related field is required (or MS with 10+ years, BS with 12+ years of industry experience)
Strong knowledge background and 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.
Experience with applying Design of Experiments (DOE), statistical analysis, and data visualization tools (JMP, Spotfire, or equivalent) for process development or characterization studies
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
Candidates must be authorized to work in the U.S

Nice To Haves

Prior experience serving as technical support for internal and external teams to manage process development and manufacturing at CDMOs is a plus
Experience with analytical assay development, qualification, transfer is a plus
Familiarity with cGMP manufacturing and regulatory expectations for biologics gene editing material or cell therapy products is a plus

Responsibilities

Serve as technical subject matter expertise supporting CDMOs to provide process 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
Assess impact of gene editing and/or gene delivery materials on CART production process
Engage with broader Process and Product Development team to contribute to achievement of Department goals
Other duties as assigned