Packaging Operations Manager (Cell Therapy)

Location: Onsite at Allogene headquarters in South San Francisco, California, United States. Authorization to work in the U.S. is required.

Salary: $140,000–$160,000 per year, plus annual performance bonus, equity, health insurance, and paid time off.

Company

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

What you will do

• Own the design, qualification, and lifecycle management of secondary and tertiary packaging systems for cryopreserved cell therapy products.
• Support qualification of cold-chain shipping systems through validation protocols, thermal mapping, transportation studies, and shipping-data analysis.
• Manage specifications, GMP documentation, artwork, materials, supplier qualification, and validation for labels, cartons, inserts, and other printed packaging components.
• Manage CMOs, contract packagers, print suppliers, and contracted cold-chain distribution partners.
• Coordinate artwork implementation, change control, printing, and collaboration with Regulatory Affairs, Marketing, Quality, Manufacturing, and Clinical Operations.
• Coordinate packaging activities required for the on-time launch of Allogene’s first commercial cell therapy product.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Packaging Science, or a related field.
• At least 3 years of experience in biopharmaceutical manufacturing, with experience in packaging design and development, cell or gene therapy, or cold-chain management.
• Knowledge of cGMP regulations and regulatory expectations.
• Familiarity with cryogenic or cold-chain packaging and autologous or allogeneic cell therapy supply chains.
• Knowledge of packaging artwork management and print processes, plus strong organizational, communication, collaboration, and problem-solving skills.
• Must be authorized to work in the United States and work onsite in South San Francisco, California.

Nice to have

• Familiarity with FDA, EMA, and Annex 13 labeling requirements.
• Experience with product launches.

Culture & Benefits

• Collaborative, fast-paced, and dynamic biotech environment.
• Annual performance bonus and equity.
• Health insurance and generous paid time off.
• Two company-wide holiday shutdowns each year.
• Opportunity to support the development and launch of cell therapy products.