Principal Scientist, Drug Product Steriles Primary Packaging

GSK

Upper Providence, PA, US
Onsite
Primary packaging component recommendation
Sterile injectables packaging specifications
Container closure integrity testing
The role provides packaging support to DDS project teams, Clinical Supply Chain, and Global Supply Chain network across modality types

Job Summary

  • The role provides packaging support to DDS project teams, Clinical Supply Chain, and Global Supply Chain network across modality types.
  • Key responsibilities include authoring IND/NDA CTX/MAA Container Closure sections and leading the characterization of container closure systems for compatibility.
  • GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing while uniting science and technology.

Matching Summary

The role provides packaging support to DDS project teams, Clinical Supply Chain, and Global Supply Chain network across modality types.

Skills & Requirements

Must-have

  • Primary packaging component recommendation
  • Sterile injectables packaging specifications
  • Container closure integrity testing
  • IND/NDA CTX/MAA Container Closure sections
  • Design control documentation authoring
  • USP/EP/JP/ChP compliance assessment

Nice-to-have

  • Experience with combination products
  • Cost effectiveness assessment of materials
  • External partner collaboration management
  • Project management for portfolio milestones
  • Ambitious culture for patients

Key Requirements

  • BS degree plus 6 years experience or MS plus 4 years or PhD
  • Engineering or related scientific discipline degree
  • Three or more years developing packaging solutions
  • Three or more years implementing regulatory standards for packaging

Work Rights

Not specified

Tailored Resume

Cover Letter