Senior Director, Process Sciences (Biotech)

TL;DR

Senior Director, Process Sciences (Cell Therapy): Driving innovation in cell therapy technologies and implementing robust CAR-T manufacturing processes across Allogene’s pipeline with an accent on Quality by Design, process characterization, and control strategies. Focus on leading Drug Substance and Drug Product teams, developing risk assessments, and enabling BLA-ready processes using DoE methodologies.

Onsite in South San Francisco, CA. Candidates must be authorized to work in the U.S.

From $230,000 to $270,000 per year

Company

Clinical-stage biotechnology company pioneering allogeneic CAR T cell (AlloCAR T™) therapies for cancer and autoimmune disease.

What you will do

• Lead Cell Starting Material, Drug Substance, and Drug Product process development teams for early and late-stage CAR-T manufacturing.
• Collaborate with internal and external partners on Project Technical Teams to ensure seamless interactions.
• Apply Quality by Design to define process-to-product relationships and robust control strategies.
• Develop risk assessments, process characterization plans using DoE, and platform knowledge.
• Contribute to regulatory filings (IND through BLA) and responses to agency questions.
• Mentor teams, establish lab practices, and stay current with field advancements.

Requirements

• PhD, MS or BS in Chemical Engineering, Biochemistry, Molecular & Cell Biology, Immunology or related field with 12+ years experience, including 5+ years in management.
• Demonstrated understanding of mammalian/primary cell culture, biochemistry, molecular & cell biology, and immunology.
• Experience managing process development, characterization, validation, and commercialization in biological processes.
• Technical and strategic leadership in cell therapy manufacturing and technology transfer.
• Authorized to work in the U.S.
• Strong leadership, interpersonal, organizational, and project management skills.

Nice to have

• Experience with viral vectors and gene editing technologies.
• Cell and gene therapy experience.

Culture & Benefits

• Collaborative environment with talented people.
• Competitive compensation including annual bonus and equity.
• Health insurance, generous time off, and 2 annual company-wide holiday shutdowns.