Scientist, Drug Product Process Science (Biotech)

TL;DR

Scientist, Drug Product Process Science (Biotech): Designing and executing process characterization studies for BLA readiness and clinical-scale manufacturing of AlloCAR T products with an accent on drug product formulation, fill/finish, and cryopreservation. Focus on establishing scale-down models, applying DOE methodologies, and ensuring process robustness for commercialization.

Location: South San Francisco, CA. Must be authorized to work in the U.S.

Salary: $50.00 - $58.00 per hour

Company

A clinical-stage biotechnology company pioneering hirify.globalic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Design and execute studies for drug product process characterization to enable BLA submission.
• Establish and qualify scale-down models (SDMs) to support characterization studies.
• Apply statistical tools and Design of Experiments (DOE) to evaluate process robustness and characterize parameters.
• Develop in-use compatibility studies and collaborate with Clin Ops on DAI and IPM implementation.
• Support process technology transfer and act as person-in-plant for troubleshooting.
• Author technical reports, Batch Records, and drug product sections for regulatory filings.

Requirements

• M.S. in Pharmaceutics, Immunology, biomedical engineering, or related field with 5+ years of industry experience (or BS with 8+ years).
• Experience in development, characterization, scale-up, or commercial manufacture of biologics or cell therapy products.
• Working knowledge of cell biology, aseptic cell culture, and cell-based analytical methods.
• Proficiency with DOE, statistical analysis, and data visualization tools such as JMP or Spotfire.
• Must be authorized to work in the U.S.

Nice to have

• Experience with electronic data systems and ELNs (e.g., Benchling).
• Familiarity with cGMP manufacturing and regulatory expectations for biologics or cell therapy.

Culture & Benefits

• Collaborative work environment with highly talented professionals.
• Compensation package including annual performance bonus and equity.
• Comprehensive health insurance and generous time off.
• Two annual company-wide holiday shutdowns.
• Fast-paced startup environment focusing on life-changing products for patients.