Sr. Manager, Packaging & Labeling

Role: Senior Manager, Packaging & Labeling responsible for designing, qualifying, and transferring packaging and labeling processes for clinical and commercial autologous cell therapies, ensuring compliance with global regulatory standards. Responsibilities: develop standardized patient-specific labeling strategies, review and validate packaging specifications, and oversee validation of cryogenic and temperature-controlled packaging systems; support scale-up and network expansion. Requirements: Bachelor's degree in Engineering, Supply Chain, or Packaging Science; 5-7 years in labeling, packaging, or artwork management within regulated GMP biopharma environments, ideally with cell/gene therapy experience; knowledge of FDA, EMA, Annex 13, and validation practices (IQ/OQ/PQ); familiarity with cryogenic cold-chain logistics; strong project management and cross-functional collaboration skills. HighValue: autologous cell/gene therapy, cryogenic packaging, clinical-to-commercial transition, global regulatory compliance, GMP validation. WorkSetup: remote; no travel specified.