Primary Packaging Materials Scientist

Blackfield Associates is supporting a leading global pharmaceutical company in the search for a Primary Packaging Materials Scientist to join their Globl Product Management team.

This role offers the opportunity to provide technical leadership for primary packaging systems supporting both development and commercial parenteral drug products.

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• Technical ownership of primary packaging components (glass vials, prefilled syringes, plastic bottles, rubber stoppers, caps).
  
• Design, development and validation of Container Closure Systems (CCS), including CCI and delamination studies.
  
• Lead lifecycle management activities: supplier changes, component improvements, and productivity initiatives.
  
• Support R&D and commercial products with packaging expertise.
  
• Author and review GMP documentation and regulatory submission content.
  
• Manage deviations, investigations, change controls and CAPAs.
  
• Present container closure strategies to regulatory authorities.
  
• Support continuity of supply and resolve manufacturing or quality issues.
  

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• Strong experience with primary packaging for parenteral pharmaceutical products.
  
• Knowledge of USP, Ph. Eur., JP and other global pharmacopeia requirements.
  
• Experience in CCS validation, regulatory documentation and GMP environments. xcfaprz
  
• Master’s or PhD in Science or Engineering (or equivalent).