Principal Analytical Steward (gmsat Small Molecules)

Roche UK

10+ years industry experience in analytical method development
In-depth knowledge of ich q2 and q14 guidelines
Experience with analytical target profile definition
The role involves acting as the primary architect of a new global analytical framework for commercial synthetic molecule products

Job Summary

  • The role involves acting as the primary architect of a new global analytical framework for commercial synthetic molecule products.
  • You will serve as the Business Process Owner, defining coordinated strategic processes between Centers of Analytics, global Quality, and gMSAT.
  • Roche offers a culture that encourages personal expression, open dialogue, and genuine connections where every voice matters.

Matching Summary

The role involves acting as the primary architect of a new global analytical framework for commercial synthetic molecule products.

Skills & Requirements

Must-have

  • 10+ years industry experience in analytical method development
  • In-depth knowledge of ICH Q2 and Q14 guidelines
  • Experience with Analytical Target Profile definition
  • Matrix leadership of analytical experts
  • Control strategy development for synthetic molecules

Nice-to-have

  • PhD in scientific discipline
  • Experience with CDMO transfers
  • Ability to shape processes in ambiguous environments
  • Cross-functional collaboration skills
  • Strategic process ownership capabilities

Key Requirements

  • M.S. degree in chemistry, pharmacy, engineering or related field
  • 10+ years relevant industry experience
  • PhD is an advantage
  • Knowledge of ICH Q8 and M4 expectations

Work Rights

Not specified

Tailored Resume

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