External Supply – Manufacturing Support - Manufacturing Process Owner

Amgen UK

Not specified
5+ years cgxp manufacturing experience
Cdmo process documentation ownership
Lean six sigma continuous improvement
Amgen UK is seeking a Manufacturing Process Owner for its External Supply - Manufacturing Support team, focusing on ensuring operational excellence in their external network. The role requires expertise in manufacturing processes, regulatory compliance, and continuous improvement initiatives within a collaborative environment

Job Summary

  • The role serves as a key subject matter expert directing initiatives to ensure execution excellence within the external CDMO network.
  • Responsibilities include owning assigned processes, leading investigations for safety and quality issues, and implementing corrective actions to prevent recurrence.
  • The position requires active engagement in Lean culture environments to drive continuous improvement projects and optimize manufacturing metrics.

Matching Summary

Match Score: 85

Amgen UK is seeking a Manufacturing Process Owner for its External Supply - Manufacturing Support team, focusing on ensuring operational excellence in their external network. The role requires expertise in manufacturing processes, regulatory compliance, and continuous improvement initiatives within a collaborative environment.

Skills & Requirements

Must-have

  • 5+ years cGxP manufacturing experience
  • CDMO process documentation ownership
  • Lean Six Sigma continuous improvement
  • CAPA and Change Control management
  • Sterile medicinal products knowledge

Nice-to-have

  • International work environment adaptability
  • Strong technical writing skills
  • Cross-functional collaboration abilities
  • Data analytics familiarity
  • Project management leadership

Key Requirements

  • Bachelor of Science or Engineering degree
  • Minimum 5 years drug product manufacturing experience
  • In-depth knowledge of Eudralex Volume 4 Annex 1

Work Rights

Not specified

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