updated 1 month ago
Sr. Scientist, Gene Editing Materials Process Development (Biotechnology)
60 - 70$
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Job description
Text:
TL;DR
Sr. Scientist, Gene Editing Materials Process Development (Biotechnology): Developing and improving manufacturing processes for gene editing and gene delivery materials used in allogeneic cell therapies with an accent on process characterization, control strategy development, and GMP manufacturing readiness. Focus on designing experiments, troubleshooting manufacturing runs at CDMOs, assessing process changes, and supporting BLA submission and commercialization.
Location: South San Francisco, California, United States; onsite. Candidates must be authorized to work in the U.S. Ability to travel up to 10%.
Salary: $60–$70 per hour
Company
is a clinical-stage biotechnology company developing allogeneic CAR T cell products for cancer and autoimmune disease.
What you will do
- Provide technical leadership for the development and improvement of gene editing and gene delivery material manufacturing processes.
- Support CDMOs with process development expertise and technical oversight for production and resupply activities.
- Contribute to process development, characterization, control strategy, PPQ planning, and commercial manufacturing readiness.
- Partner with R&D, External Manufacturing, MSAT, Quality, and external partners to align process and method changes.
- Plan, execute, and troubleshoot process development and GMP manufacturing runs at CDMOs.
- Develop experiments to assess the impact of gene editing and gene delivery materials on CAR T production.
Requirements
- PhD in biological sciences, engineering, or a related discipline with 5+ years of relevant experience; equivalent alternatives include an MS with 10+ years or a BS with 12+ years of industry experience.
- Direct experience developing, characterizing, scaling, or supporting GMP manufacturing processes for gene editing or gene delivery materials.
- Experience with Design of Experiments, statistical analysis, and data visualization tools such as JMP or Spotfire.
- Strong written and verbal communication skills, independence, organization, and ability to work in a matrixed environment.
- U.S. work authorization is required.
Nice to have
- Experience supporting internal and external teams with process development and manufacturing at CDMOs.
- Experience with analytical assay development, qualification, and transfer.
- Familiarity with cGMP manufacturing and regulatory expectations for biologics, gene editing materials, or cell therapy products.
Culture & Benefits
- Collaborative work environment with cross-functional and external partnerships.
- One-year contract opportunity with potential for extension or contract-to-hire.
- Opportunity to contribute to the development of life-changing cell therapy products.
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