About the Role
Payrate: $ - $
Responsibilities:
Lead development and optimization of secondary & tertiary packaging for biologics, sterile injectables, and combination products (, prefilled syringes, autoinjectors). Create and maintain component specifications for vials, stoppers, syringes, seals, cartons, labels, and distribution packaging. Develop and execute packaging test protocols including: Transportation simulation (ISTA/ASTM) Aging and self-life studies Cold-chain and environmental conditioning Packaging line engineering studies Ensure compliance with global regulatory expectations (FDA, EMA, ISO ). Prepare and review packaging documentation for regulatory submissions. Support tech transfer, scale-up, and readiness activities at manufacturing sites and CMOs. Lead investigations into packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement. Partner...