Senior Associate Manufacturing - Continuous Improvement Lead
Amgen
July 02, 2026
On-site
Holly Springs, NC
Operations
Senior Associate Manufacturing - Continuous Improvement Lead
What You Will Do
In this role, you will support the start-up of the Amgen North Carolina (ANC) manufacturing facility and, starting in 2025, manage and lead the Continuous Improvement (CI) program for Manufacturing.
- Provide technical support and subject matter expertise for a manufacturing area.
- Oversee support and ongoing development of manufacturing systems (e.g., SOP, TRNQ, MES, QMS records).
- Train staff (associates, operators, technical/QA/support) on assigned manufacturing systems.
- Support troubleshooting during commissioning/qualification, start-up, engineering run, and process performance qualification.
- Facilitate process, area, and equipment quality risk assessments to identify risks, failure modes, and mitigation actions.
- When in production: manage the CI program, including time studies, improvement projects, change management, and sustainment tracking.
- Lead cross-functional CAPAs and EVs as required.
- Serve as a CI and Human and Organizational Performance champion; provide training on CI and lean principles.
- Lead learning team meetings and kaizen events.
What We Expect Of You
Basic Qualifications:
- High school diploma/GED and 4 years of Manufacturing or Operations experience OR
- Associate’s degree and 2 years OR
- Bachelor’s degree and 6 months OR
- Master’s degree.
Preferred Qualifications:
- Background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering.
- Strong knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and bioprocessing.
- Proficient technical writing and presentation skills.
- Ability to lead cross-functional meetings.
- Knowledge of process improvement/lean fundamentals.
- Ability to collaborate across manufacturing, process development, engineering, supply chain, and quality.
Application Instructions:
- Apply at careers.amgen.com.
What You Will Do
In this role, you will support the start-up of the Amgen North Carolina (ANC) manufacturing facility and, starting in 2025, manage and lead the Continuous Improvement (CI) program for Manufacturing.
- Provide technical support and subject matter expertise for a manufacturing area.
- Oversee support and ongoing development of manufacturing systems (e.g., SOP, TRNQ, MES, QMS records).
- Train staff (associates, operators, technical/QA/support) on assigned manufacturing systems.
- Support troubleshooting during commissioning/qualification, start-up, engineering run, and process performance qualification.
- Facilitate process, area, and equipment quality risk assessments to identify risks, failure modes, and mitigation actions.
- When in production: manage the CI program, including time studies, improvement projects, change management, and sustainment tracking.
- Lead cross-functional CAPAs and EVs as required.
- Serve as a CI and Human and Organizational Performance champion; provide training on CI and lean principles.
- Lead learning team meetings and kaizen events.
What We Expect Of You
Basic Qualifications:
- High school diploma/GED and 4 years of Manufacturing or Operations experience OR
- Associate’s degree and 2 years OR
- Bachelor’s degree and 6 months OR
- Master’s degree.
Preferred Qualifications:
- Background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering.
- Strong knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and bioprocessing.
- Proficient technical writing and presentation skills.
- Ability to lead cross-functional meetings.
- Knowledge of process improvement/lean fundamentals.
- Ability to collaborate across manufacturing, process development, engineering, supply chain, and quality.
Application Instructions:
- Apply at careers.amgen.com.