Senior Scientist, Gene Editing Materials Process Development

This is a fully remote position, open to applicants in California.

📋 Description

• Act as a technical subject matter expert, providing process development expertise for gene editing and/or gene delivery materials to CDMOs.

• Deliver technical leadership throughout the product lifecycle, from initial process development to process characterization, control strategy formulation, commercial manufacturing readiness, BLA submission, and product commercialization.

• Offer technical oversight to support the production and replenishment of gene delivery and gene editing materials.

• Collaborate with internal and external R&D, External Manufacturing, MSAT, and Quality teams.

• Engage in process development, process characterization, control strategy formulation, and PPQ planning.

• Evaluate the effects of process and method modifications for gene editing and/or gene delivery materials.

• Aid in the planning, execution, and troubleshooting of Process Development and GMP runs at CDMOs.

• Analyze the influence of gene editing and/or gene delivery materials on the CAR T production process.

• Contribute to the objectives of the Process and Product Development department.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• PhD in biological sciences, engineering, or a related field with 5+ years of pertinent experience in process development for the manufacturing of gene and cell therapy or a related area is required; alternatively, an MS with 10+ years or a BS with 12+ years of industry experience is acceptable.

• Strong expertise and hands-on experience in developing, characterizing, scaling, or supporting GMP manufacturing processes for gene editing materials and/or gene delivery materials is highly preferred.

• Proficient in Design of Experiments (DOE), statistical analysis, and data visualization tools such as JMP, Spotfire, or similar platforms.

• Previous experience in supporting both internal and external teams in managing process development and manufacturing at CDMOs is advantageous.

• Familiarity with analytical assay development, qualification, and transfer is a plus.

• Knowledge of cGMP manufacturing and regulatory requirements for biologics gene editing materials or cell therapy products is beneficial.

• Excellent verbal and written communication skills.

• Ability to work independently as well as collaboratively in a matrixed environment.

• Strong organizational and prioritization capabilities.

• Willingness to travel up to 10%.

• Candidates must possess authorization to work in the U.S.

• This position is a 1-year contract opportunity with potential for extension or transition to permanent hire.

🏝️ Benefits

• Opportunity for contract extension or transition to permanent hire.

• Collaborative work environment.

• Travel opportunities to San Francisco and various CDMO locations.