External Supply – Manufacturing Support - Manufacturing Process Owner
Amgen Inc
Not specified (could be hybrid or onsite based on typical pharmaceutical industry practices)
5+ years cgxp manufacturing experience
Cdmo process documentation ownership
Lean six sigma continuous improvement
Amgen Inc is seeking a Manufacturing Process Owner for their External Supply - Manufacturing Support team, which requires expertise in aseptic processes and operational oversight. The role involves ensuring execution excellence in manufacturing, troubleshooting, and implementing continuous improvement initiatives
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, managing investigations, and implementing CAPAs to prevent future reoccurrence of 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 Inc is seeking a Manufacturing Process Owner for their External Supply - Manufacturing Support team, which requires expertise in aseptic processes and operational oversight. The role involves ensuring execution excellence in manufacturing, troubleshooting, and implementing continuous improvement initiatives.
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
International travel capability
Cross-functional collaboration
Data analytics familiarity
Project management experience
Key Requirements
Bachelor of Science, Engineering or technical discipline
5+ years manufacturing experience in Drug Substance or Product