Senior Associate, Cell Therapy Manufacturing (Biotech)

TL;DR

Senior Associate, Cell Therapy Manufacturing (Biotech): Supporting the GMP manufacture of hirify.globalic CAR T cell products with an accent on aseptic processing and regulatory compliance. Focus on operational readiness, tech transfer, and ensuring the integrity and sterility of cell therapy products throughout the production cycle.

Location: Newark, CA. Candidates must be authorized to work in the U.S.

Salary: $45.00 – $50.00 per hour

Company

hirify.global Therapeutics is a clinical-stage biotechnology company pioneering the development of hirify.globalic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Perform process unit operations including PBMC, media and solution preparation, and CAR-T drug substance/product fill operations.
• Maintain strict aseptic techniques to ensure the integrity, viability, and sterility of cell therapy products.
• Complete batch records and documentation accurately and timely according to SOPs and protocols.
• Assist in the setup and operation of complex automated cell processing, expansion, and filling equipment.
• Update and revise manufacturing operating procedures to ensure cGMP compliance and operational efficiency.
• Monitor, clean, and prepare processing and analytical equipment in Grade B/C areas.

Requirements

• Bachelor’s or associate degree in a relevant science or engineering discipline.
• At least 4 years of experience in cGMP biologics or cell therapy manufacturing.
• Experience with aseptic processing in Grade A biosafety cabinets and Grade B clean rooms.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy.
• Authorization to work in the U.S. is required.
• Ability to perform physical tasks including lifting up to 30 pounds and working in cold rooms/freezers.

Nice to have

• Cell culture processing experience in handling and propagation of human primary cells.

Culture & Benefits

• Collaborative work environment with a talented team of biotechnology experts.
• Competitive compensation package including an annual performance bonus and equity.
• Comprehensive health insurance and generous time off.
• Two annual company-wide holiday shutdowns.