Packaging Operations Lead, Cold Chain & Launch

Allogene Therapeutics; South San Francisco (CA); On-site; USD 140,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

Equity

Health insurance

Generous time off

Job summary

Allogene Therapeutics seeks a Packaging Operations Manager to lead the design, qualification, and lifecycle management of packaging systems for cryopreserved cell therapy products. You will ensure GMP compliance across manufacturing, storage, shipping, and clinical-to-commercial transitions.

The role requires a bachelor's degree in Life Sciences/Engineering/Packaging Science and 3+ years in biopharma packaging, with strong regulatory knowledge and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Packaging Science or related field.
• 3+ years in biopharmaceutical manufacturing with packaging/ Cold Chain experience.
• Knowledge of cGMP regulations and regulatory expectations; FDA/EMA familiarity is a plus.
• Familiarity with cryogenic/cold-chain packaging and autologous or allogeneic cell therapy supply chains.
• Experience with product launches.
• Excellent communication and cross-functional collaboration abilities.

Responsibilities

• Own the design, qualification, and lifecycle management of packaging systems for cryopreserved cell therapy products.
• Support qualification of cold chain shipping systems and analyze shipping data for improvements.
• Lead packaging design, GMP documentation, artwork coordination, and supplier qualification.
• Manage CMOs for secondary/tertiary packaging and contracted cold chain distribution.
• Coordinate all packaging-related launch activities for the first commercial product.

Skills

Packaging lifecycle management

Cold chain management

Cross-functional collaboration

Regulatory knowledge (cGMP)

Project management

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Bachelor's degree in Packaging Science

Job description

Allogene Therapeutics seeks a Packaging Operations Manager to lead the design, qualification, and lifecycle management of packaging systems for cryopreserved cell therapy products. You will ensure GMP compliance across manufacturing, storage, shipping, and clinical-to-commercial transitions.

The role requires a bachelor's degree in Life Sciences/Engineering/Packaging Science and 3+ years in biopharma packaging, with strong regulatory knowledge and cross-functional collaboration skills.