Senior Manager, Packaging & Labeling

Job Summary

Serving as the primary technical expert, the full-time Senior Manager, Packaging & Labeling will manage the design, qualification, and technology transfer of clinical and commercial labeling and packaging configurations remotely, ensuring compliance with global regulatory requirements and maintaining product integrity throughout the supply chain.

Key responsibilities

• Develop and standardize patient-specific labeling strategies across various stakeholders, ensuring consistent execution and compliance
• Design, qualify, and validate temperature-controlled packaging systems to maintain chain of identity and product integrity
• Establish validation strategies ensuring compliance with 21 CFR Part 11 and GMP, including oversight of vendor validation documentation

Required qualifications

• Bachelor's degree or equivalent in Engineering, Supply Chain, Packaging Science, or a related field
• 5-7 years of experience in labeling, packaging, or artwork management within biopharmaceutical or regulated GMP environments
• Working knowledge of FDA, EMA, and Annex 13 labeling requirements, with 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 cell therapy supply chains strongly preferred