Join Our Crew

Responsibilities Include

Labeling

• Develop and standardize patient-specific labeling strategies across CMOs, clinical sites, depots, and logistics providers, providing oversight to ensure consistent execution without direct operational ownership.
• Define standards for label readability, human factors, and required data elements; ensure label performance under cryogenic, condensation, and transport conditions.
• Review packaging specifications, labeling content, and artwork for accuracy and compliance; own SOPs, specifications, and governance, including change control, deviations/CAPAs, and reconciliation/destruction oversight.
• Ensure labeling meets global regulatory requirements (FDA, EMA, Annex 13, country-specific rules) and support IND/BLA filings and inspections
• Establish validation strategies ensuring 21 CFR Part 11 and GMP compliance, including review and approval of IQ/OQ/PQ and vendor validation documentation

Packaging

• Design, qualify, and validate patient-specific, temperature-controlled packaging systems (cryogenic shippers, LN2 dewars, ambient kits; e.g., ≤ -150°C vapor phase LN2, refrigerated) to maintain chain of identity and product integrity.
• Ensure packaging supports vein-to-vein logistics timing constraints; manage container closure integrity and compatibility with cryogenic storage and handling.
• Perform risk assessments for packaging failures impacting patient material.
• Support scale-up network expansion, including new CMOs, new regions, and the clinical-to-commercial transition.
• Other related duties, as assigned.

Required Qualifications

• Bachelor's degree or equivalent (preferred concentration in 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 environments; relevant experience in autologous cell & gene therapy is ideal.
• Working knowledge of FDA, EMA, and Annex 13 labeling requirements; experience supporting IND/BLA filings preferred.
• Experience with 21 CFR Part 11, GMP, and validation practices (IQ/OQ/PQ).
• Familiarity with cryogenic or cold-chain packaging and patient-specific (autologous) cell therapy supply chains strongly preferred.
• Demonstrated ability to manage cross-functional relationships and external vendor/CMO oversight without direct operational authority.
• Strong project management, documentation, and change-control skills.

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