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About the Role
Duration: 12 months Contract
Responsibilities:
Develop and execute packaging test protocols including:
Responsibilities:
- 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...
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