Senior Associate Manufacturing - Continuous Improvement Lead

Responsibilities

• Support the start-up and operational readiness of the North Carolina manufacturing facility
• Provide technical support and subject matter expertise for manufacturing areas including Upstream, Downstream, and Buffer/Media Preparation
• Oversee the development of manufacturing systems such as SOPs, MES, and QMS records
• Train staff on assigned manufacturing systems and lean principles
• Support troubleshooting during commissioning, qualification, and engineering runs
• Facilitate quality risk assessments to identify failure modes and mitigating actions
• Manage the Continuous Improvement (CI) program by conducting time studies and leading improvement projects
• Lead cross-functional CAPAs, learning team meetings, and Kaizen events

Requirements

• High school diploma/GED with 4 years of Manufacturing or Operations experience
• Associate's degree with 2 years of Manufacturing or Operations experience
• Bachelor's degree with 6 months of Manufacturing or Operations experience
• Master's degree
• Strong project management and innovative thinking skills

Preferred Qualifications

• Educational background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, or Engineering
• Technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding)
• Knowledge of lean fundamentals and process improvement
• Proficient technical writing and presentation skills
• Ability to lead cross-functional meetings and collaborate with diverse organizational levels

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases by leveraging human genetics and biologics manufacturing expertise to deliver innovative medicines worldwide.