Senior Manager, Packaging & Labeling

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Act as the primary technical authority for the design, qualification, and technology transfer of clinical and commercial label, artwork, and packaging configurations throughout the global CDMO network.

• Ensure a robust chain of identity (COI) and chain of custody (COC).

• Develop and standardize labeling strategies tailored to patients across CMOs, clinical sites, depots, and logistics providers.

• Oversee the consistent execution of labeling without direct operational control.

• Establish standards for label readability, human factors, and necessary data elements.

• Ensure label performance under cryogenic, condensation, and transportation conditions.

• Review packaging specifications, labeling content, and artwork for precision and compliance.

• Own SOPs, specifications, and governance, including change control, deviations/CAPAs, and oversight of reconciliation/destruction.

• Ensure that labeling adheres to global regulatory standards and support IND/BLA filings and inspections.

• Develop validation strategies for compliance with 21 CFR Part 11 and GMP.

• Review and approve IQ/OQ/PQ and vendor validation documentation.

• Design, qualify, and validate patient-specific, temperature-controlled packaging systems.

• Ensure packaging accommodates vein-to-vein logistics timing requirements.

• Manage container closure integrity and compatibility with cryogenic storage and handling.

• Conduct risk assessments for packaging failures that may impact patient material.

• Support network expansion, onboarding new CMOs, new regions, and the transition from clinical to commercial.

• Perform other related duties as assigned.

⛳️ Requirements

• Bachelor's degree or equivalent (preferably focused on Engineering, Supply Chain, Packaging Science, or a related field).

• 5–7 years of experience in labeling, packaging, or artwork management within biopharmaceutical, cell therapy, or regulated GMP manufacturing settings.

• Relevant experience in autologous cell & gene therapy is highly desirable.

• Working knowledge of FDA, EMA, and Annex 13 labeling standards.

• Experience in supporting IND/BLA filings is preferred.

• Familiarity with 21 CFR Part 11, GMP, and validation practices (IQ/OQ/PQ).

• Strong preference for experience with cryogenic or cold-chain packaging and patient-specific (autologous) cell therapy supply chains.

• Ability to manage cross-functional relationships and external vendor/CMO oversight without direct operational authority.

• Excellent project management, documentation, and change-control skills.

🏝️ Benefits

• Competitive benefits.

• PTO.

• Stock option plans.