Director, Process Development (Cell Therapy)

Location: South San Francisco, California, United States; on-site

Salary: $170,000–$240,000 per year

Company

hirify.global develops and operates integrated automated manufacturing technologies for cell therapies through its Cell Shuttle platform and Smart Factories.

What you will do

• Lead the Enterprise Programs team within Process Development and manage scientists and research associates.
• Manage technology transfer and process development activities supporting regulatory filings.
• Translate manual and automated client manufacturing processes onto the Cell Shuttle platform.
• Develop standards, templates, protocols, batch records, and best practices for moving processes into characterization and manufacturing.
• Plan resources, budgets, headcount, quarterly goals, and continuous improvements across the team and processes.
• Support verification, validation, performance qualification, analytical assessment, technical reports, and regulatory submissions.

Requirements

• PhD, M.S., or B.S. in biological sciences such as molecular biology, immunology, or genetics.
• 4+ years of experience in cell and gene therapy manufacturing or process development, including at least two years in industry.
• Experience with genetically modified cell therapy modalities, including CAR-T, TCR, HSCs, or CD34+ cells.
• Experience with autologous and allogeneic manufacturing workflows in preclinical, clinical, or commercial environments.
• Experience leading process development teams, managing client relationships, designing experiments, troubleshooting, and analyzing scientific data.
• Experience in GMP environments, process optimization and characterization, technology transfer, and communicating scientific results to technical and non-technical audiences.

Nice to have

• Experience interfacing with the FDA.
• PhD or post-doctoral experience in gene or cell therapy.
• Experience authoring CMC sections for IND, IMPD, and NDA submissions.
• Experience with management and process improvement tools such as root cause analysis and value stream mapping.

Culture & Benefits

• Mission-driven, fast-paced environment focused on scaling access to cell therapies.
• Highly subsidized medical, dental, and vision plans.
• 401(k) matching and stock options.
• Free EV charging and on-site lunches.
• Travel of up to 15% is required.