Job Description
Location: Thousand Oaks, CA Fully Onsite - Standard Hours
Function: Process Development / Engineering / Operations
________________________________________
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:
o Transportation simulation (ISTA/ASTM)
o Aging and shelf-life studies
o Cold-chain and environmental conditioning
o 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...
Function: Process Development / Engineering / Operations
________________________________________
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:
o Transportation simulation (ISTA/ASTM)
o Aging and shelf-life studies
o Cold-chain and environmental conditioning
o 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...