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

Location: South San Francisco, California, United States. Candidates must be authorized to work in the U.S.; travel up to 10% may be required.

Salary: $60–$70 per hour. This is a 1-year contract opportunity with possible extension or contract-to-hire.

Company

hirify.global is a clinical-stage biotechnology company developing allogeneic CAR T cell therapies for cancer and autoimmune disease.

What you will do

• Provide technical leadership for development and improvement of manufacturing processes for gene editing and gene delivery materials.
• Support CDMOs with process development expertise and technical oversight for production and re-supply activities.
• Contribute to process development, characterization, control strategy development, PPQ planning, and commercial manufacturing readiness.
• Partner with R&D, External Manufacturing, MSAT, Quality, and external manufacturing organizations.
• Assess process and method changes, execute experiments, and evaluate effects on CAR T cell production.
• Plan, execute, and troubleshoot process development and GMP manufacturing runs.

Requirements

• PhD in biological sciences, engineering, or a related discipline with 5+ years of relevant experience; alternatively, an MS with 10+ years or BS with 12+ years of industry experience.
• Direct experience developing, characterizing, scaling, or supporting GMP manufacturing processes for gene editing materials such as mRNA and nucleases, and/or gene delivery materials such as AAV, lentiviral vectors, or non-viral delivery systems.
• Experience applying Design of Experiments, statistical analysis, and data visualization tools such as JMP, Spotfire, or equivalent.
• Strong communication, organizational, prioritization, and independent working skills in a matrixed environment.
• Must be authorized to work in the U.S.

Nice to have

• Technical support experience for internal and external teams managing 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 environment involving internal teams and external manufacturing partners.
• Opportunity to support development of cell therapy products intended to improve access to scalable, on-demand treatments.
• Contract engagement with possible extension or conversion to hire.