Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., 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 shelf-life studies
Cold-chain and environmental conditioning
Packaging line engineering studies
Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607, USP).
Prepare and review packaging documentation for regulatory submissions.
Support tech transfer, scale-up, and readiness activities at manufact...