Job Description

Duration: 12 months Contract

 

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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