Job Description
About the role:Allogene Therapeutics is seeking a highly motivated Packaging Operations Manager to support the design, qualification, and lifecycle management of packaging systems, labeling components, and cold chain packaging supporting the manufacture and distribution of Allogene's clinical and commercial cell therapy products. This role helps ensure that packaging and labeling systems for the company's first product launch comply with GMP, regulatory, and patient-specific requirements while maintaining product integrity throughout manufacturing, cryogenic storage, transportation, and delivery. This role supports the preparation and launch of Allogene's first commercial cell therapy product.
The position will be located at Allogene headquarters in South San Francisco, CA. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges.
Responsibilities include, but are not limited to:- Packaging Engineering: Own the design, qualification, and lifecycle management of secondary/tertiary packaging systems for cryopreserved cell therapy products, ensuring product quality and protection across manufacturing, storage, shipping, and clinical-to-commercial transitions.
- Cold Chain Packaging Systems: Support the technical performance and qualification of cold chain shipping systems (dry shippers, temperature monitors, data loggers, insulated containers) by managing Validation protocols, thermal mapping, and lane/transportation validation studies, and analyzing shipping data to drive corrective actions.
- Packaging Design and Engineering: Support the technical lifecycle, specifications, and GMP-compliant documentation of printed packaging components (labels, cartons, IFUs, inserts) and lead Allogene's commercial packaging design and validation - including supplier qualification, cryogenic/transport performance testing, artwork and material selection, and packaging-related risk assessments impacting patient material.
- CMO and Supplier Management: manage chosen CMOs for secondary and tertiary packaging, including manufacturers, contract packagers, and contracted cold chain distribution.
- Artwork and Printing Management: Serve as the lead for artwork implementation, verifying manufacturability, packaging compatibility, and specification alignment while supporting change control and collaborating with Regulatory Affairs, Marketing and Quality on approved labeling updates. Manage print suppliers, coordinate printing and troubleshoot printing issues.
- First product launch: Ensure completion of activities to ensure on on-time launch for Allogene's first commercial product. Coordinate all packaging related launch activities.
Position Requirements & Experience:- Bachelor's degree in Life Sciences, Engineering, Packaging Science, or a related field with at least 3 years of experience in biopharmaceutical manufacturing, with a strong preference for cell or gene therapy, package design and development, and/or cold chain management.
- Knowledge of cGMP regulations and regulatory expectations; familiarity with FDA, EMA, and Annex 13 labeling requirements is a plus.
- Familiarity with cryogenic or cold-chain packaging and autologous or allogeneic 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 different stakeholders, including Manufacturing, Quality, Regulatory, Clinical Operations, Process Development, and others.
- Ability to effectively work in a fast-paced, biotech environment while dealing with ambiguity.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Excellent communication and problem-solving skills, with a desire to improve upon established processes.
- Candidates must be authorized to work in the U.S.
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $140,000 to $160,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
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