Packaging Operations Lead, Cold Chain for Cell Therapy

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

Benefits offered by this job

Annual performance bonus

Equity

Health insurance

Generous time off

Company-wide shutdowns

Job summary

Allogene Therapeutics Inc. in South San Francisco, CA, seeks a Packaging Operations Manager to design, qualify, and lifecycle-manage packaging systems and labeling for clinical and commercial cell therapy products.

You will ensure GMP-compliant packaging, support cold chain performance, and coordinate packaging activities for the first commercial launch. The role requires a Bachelor's in Life Sciences/Engineering/Packaging Science and 3+ years in biopharma packaging.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Packaging Science or related field with 3+ years in biopharmaceutical manufacturing.
• Knowledge of cGMP regulations and regulatory expectations; familiarity with FDA/EMA/Annex 13 labeling is a plus.
• Experience with cryogenic or cold-chain packaging and cell therapy supply chains is strongly preferred.
• Knowledge of artwork management and print processes for packaging components.
• Experience with product launches is preferred.
• Ability to communicate and collaborate with stakeholders across Manufacturing, Quality, Regulatory, Clinical Operations, and Process Development.

Responsibilities

• Packaging Engineering: own the design, qualification, and lifecycle management of secondary/tertiary packaging systems for cryopreserved cell therapy products.
• Cold Chain Packaging Systems: manage validation protocols, thermal mapping, and shipping data analysis to drive corrective actions.
• Packaging Design and Engineering: support specifications and GMP documentation for packaging components and lead commercial packaging design and validation.
• CMO and Supplier Management: manage CMOs for packaging and contracted cold chain distribution.
• Artwork and Printing Management: lead artwork implementation and coordinate with printing suppliers and change control.
• First product launch: coordinate all packaging-related launch activities for Allogene’s first commercial product.

Skills

Cell/gene therapy experience

Packaging design and development

Cold chain management

Regulatory awareness (cGMP/FDA)

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences/Engineering/Packaging Science

Job description

Allogene Therapeutics Inc. in South San Francisco, CA, seeks a Packaging Operations Manager to design, qualify, and lifecycle-manage packaging systems and labeling for clinical and commercial cell therapy products.

You will ensure GMP-compliant packaging, support cold chain performance, and coordinate packaging activities for the first commercial launch. The role requires a Bachelor's in Life Sciences/Engineering/Packaging Science and 3+ years in biopharma packaging.