Sr. Manager, Packaging & Labeling

Reporting to the Director, Network Planning, the Sr. Manager, Packaging & Labeling serves as the primary technical expert for the design, qualification, and technology transfer of clinical and commercial label, artwork, and packaging configurations across our global network of Contract Development and Manufacturing Organizations (CDMOs), ensuring robust chain of identity (COI) and chain of custody (COC) throughout. Responsibilities: 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. Qualifications: