Senior Associate Manufacturing - Continuous Improvement Lead
Amgen
June 29, 2026
On-site
Holly Springs, NC
Operations
Senior Associate Manufacturing - Continuous Improvement Lead
What You Will Do
- Support start-up of the Amgen North Carolina (ANC) manufacturing facility.
- Own/oversee operational readiness activities in manufacturing areas (Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, or Column Packing).
- Support SOP creation/review/approval; specify/purchase equipment and supplies; design job aids/work instructions; advance digital tools; train staff.
- Manage/lead the CI program for MFG upon transition to operations in 2025.
- Provide technical support/subject matter expertise.
- Oversee and develop manufacturing systems (SOP, TRNQ, MES, QMS records, etc.).
- Train associates, operators, and technical/QA/support staff on systems.
- Support troubleshooting during commissioning/qualification, start-up, engineering run, and process performance qualification.
- Facilitate quality risk assessments; manage time studies, improvement projects, change management, and sustainment.
- Lead cross-functional CAPAs and EVs; lead CI and Human & Organizational Performance; run learning meetings and kaizen events.
Basic Qualifications
- High school diploma/GED + 4 years Manufacturing or Operations OR
- Associate’s degree + 2 years OR
- Bachelor’s degree + 6 months OR
- Master’s degree.
Preferred Qualifications
- Life Sciences/Chemistry/Biochemistry/Industrial Biotechnology/Engineering background.
- Technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding).
- Technical writing/presentation skills; lead cross-functional meetings.
- Process improvement/lean fundamentals; collaborate across manufacturing, process development, engineering, supply chain, and quality.
What You Can Expect Of Us
- Base salary plus competitive Total Rewards Plans.
Application Instructions
- Apply now via careers.amgen.com.
What You Will Do
- Support start-up of the Amgen North Carolina (ANC) manufacturing facility.
- Own/oversee operational readiness activities in manufacturing areas (Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, or Column Packing).
- Support SOP creation/review/approval; specify/purchase equipment and supplies; design job aids/work instructions; advance digital tools; train staff.
- Manage/lead the CI program for MFG upon transition to operations in 2025.
- Provide technical support/subject matter expertise.
- Oversee and develop manufacturing systems (SOP, TRNQ, MES, QMS records, etc.).
- Train associates, operators, and technical/QA/support staff on systems.
- Support troubleshooting during commissioning/qualification, start-up, engineering run, and process performance qualification.
- Facilitate quality risk assessments; manage time studies, improvement projects, change management, and sustainment.
- Lead cross-functional CAPAs and EVs; lead CI and Human & Organizational Performance; run learning meetings and kaizen events.
Basic Qualifications
- High school diploma/GED + 4 years Manufacturing or Operations OR
- Associate’s degree + 2 years OR
- Bachelor’s degree + 6 months OR
- Master’s degree.
Preferred Qualifications
- Life Sciences/Chemistry/Biochemistry/Industrial Biotechnology/Engineering background.
- Technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding).
- Technical writing/presentation skills; lead cross-functional meetings.
- Process improvement/lean fundamentals; collaborate across manufacturing, process development, engineering, supply chain, and quality.
What You Can Expect Of Us
- Base salary plus competitive Total Rewards Plans.
Application Instructions
- Apply now via careers.amgen.com.