CMC Leader (Director)

GlaxoSmithKline · stevenage, england, United-Kingdom

Location
stevenage
Job Type
Full-time
Posted
June 30, 2026

Job Description

Position Summary

Lead the development, industrialisation, and lifecycle delivery of the assigned physical medicine (small molecule or oligonucleotide) from Commit to Phase 2 (C2P2) through to commercial launch, including global file preparation, launch readiness, and post‑launch lifecycle activities.

Responsibilities

  • Engage with the medicine 6–12 months prior to C2P2 to prepare plans, resources, and budgets.
  • Define the medicine development strategy and commercial vision with the Medicine Development Leader and team.
  • Generate options and recommendations for Phase 3 (P3) development, supply, and global regulatory filings that balance time, cost, resources, and risk.
  • Lead the execution of Product Performance Qualification (PPQ), Continuous Process Verification (CPV), and PAI readiness.
  • Support global file, review, and launch readiness; oversee packaging, plus post‑launch needs and lifecycle projects.
  • Communic...

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