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Senior Scientist, Gene Editing Materials Process Development

🔥 0 minutes ago

🏄 California – Remote

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đź’µ $60 - $70 / hour

⏳ Contract/Temporary

đźź  Senior

đź‘» Ghost score 0%

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Logo of Allogene Therapeutics

Allogene Therapeutics

201 - 500 employees

Founded 2017

🧬 Biotechnology

đź’Š Pharmaceuticals

Biotechnology • Pharmaceuticals

Allogene Therapeutics is a clinical-stage biotechnology company headquartered in South San Francisco developing allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer and autoimmune diseases. The company focuses on immunotherapy and oncology, leveraging off-the-shelf CAR T approaches to create allogeneic cell therapy products targeting hematologic malignancies and potentially autoimmune indications.

đź“‹ Description

• Serve as technical subject matter expert supporting CDMOs with process development expertise for gene editing and/or gene delivery materials • Provide technical leadership across the product lifecycle, from early-stage process development through process characterization, control strategy development, commercial manufacturing readiness, BLA submission, and commercialization • Provide technical oversight supporting production and re-supply of gene delivery and gene editing materials • Partner with internal and external R&D, External Manufacturing, MSAT, and Quality teams • Contribute to process development, process characterization, control strategy development, and PPQ planning • Assess impacts of process and method changes for gene editing and/or gene delivery materials • Support planning, execution, and troubleshooting of Process Development and GMP runs at CDMOs • Assess the impact of gene editing and/or gene delivery materials on the CAR T production process • Contribute to Process and Product Development department goals • Perform other duties as assigned

🎯 Requirements

• PhD in biological sciences, engineering or related discipline with 5+ years of relevant experience in process development for manufacturing of gene and cell therapy or related field required; alternatively, MS with 10+ years or BS with 12+ years of industry experience • Strong knowledge and direct experience developing, characterizing, scaling, or supporting GMP manufacturing processes for gene editing materials and/or gene delivery materials strongly preferred • Experience with Design of Experiments (DOE), statistical analysis, and data visualization tools such as JMP, Spotfire, or equivalent • Prior experience supporting internal and external teams managing process development and manufacturing at CDMOs is a plus • Experience with analytical assay development, qualification, and transfer is a plus • Familiarity with cGMP manufacturing and regulatory expectations for biologics gene editing material or cell therapy products is a plus • Strong verbal and written communication skills • Ability to work independently and in a matrixed environment • Excellent organizational and prioritization skills • Ability to travel up to 10% • Candidates must be authorized to work in the U.S. • This is a 1-year contract opportunity with possible extension or contract-to-hire

🏖️ Benefits

• Possibility of contract extension or contract-to-hire • Collaborative environment • Travel opportunity to San Francisco and various CDMO sites

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