External Supply – Manufacturing Support - Manufacturing Process Owner
Amgen Australia Pty Ltd
Hybrid
5+ years cgxp manufacturing experience
Cdmo process documentation ownership
Lean six sigma continuous improvement
Amgen Australia is seeking a Manufacturing Process Owner for their External Supply - Manufacturing Support team, focusing on ensuring execution excellence in manufacturing processes. The ideal candidate will possess in-depth technical knowledge and operational experience, taking ownership of assigned processes to drive improvements in safety, quality, and compliance
Job Summary
The role serves as a key subject matter expert directing initiatives to ensure execution excellence in the external CDMO network.
Responsibilities include owning assigned processes, leading investigations, and implementing CAPAs to prevent future safety or quality issues.
The position requires active engagement in Lean culture environments to drive continuous improvement projects within agreed timelines.
Matching Summary
Match Score: 85
Amgen Australia is seeking a Manufacturing Process Owner for their External Supply - Manufacturing Support team, focusing on ensuring execution excellence in manufacturing processes. The ideal candidate will possess in-depth technical knowledge and operational experience, taking ownership of assigned processes to drive improvements in safety, quality, and compliance.
Skills & Requirements
Must-have
5+ years cGxP manufacturing experience
CDMO process documentation ownership
Lean Six Sigma continuous improvement
Investigation and CAPA implementation
Sterile product manufacturing knowledge
Nice-to-have
Strong technical writing skills
Cross-functional collaboration abilities
International environment adaptability
Data analytics familiarity
Project management leadership
Key Requirements
Bachelor of Science, Engineering or technical discipline
5+ years manufacturing experience in Drug Substance/Product
In-depth knowledge of Eudralex Volume 4 Annex 1
Regulatory compliance experience in cGxP manufacturing