Sr. Manager Quality Control - Chemistry
Amgen
5 days ago
On-site
Holly Springs, NC
Operations
SR. MANAGER QUALITY CONTROL – CHEMISTRY
Responsibilities:
- Lead QC Chemistry laboratory and 1st/2nd shift Quality Control operations; oversee startup, operational readiness, and transition to steady-state commercial operations.
- Manage day-to-day QC Chemistry operations and 1st/2nd shift QC teams (7 days/week cross-functional night shift support).
- Lead analytical method transfer, qualification/validation, and routine testing.
- Support analytical method families: chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and compendial chemistry testing.
- Ensure compliance with safety guidelines, cGLPs, cGMPs, and applicable regulations.
- Build/coach/develop a high-performing QC organization; implement effective digital tools.
- Partner cross-functionally with Manufacturing, Process Development, QA, Facilities & Engineering, Supply Chain, and others.
- Support regulatory inspections and site licensure/inspection readiness.
- Drive Lean principles, establish goals/KPIs/staffing models for sustainable 24/7 operations, translate technical data to actionable insights, and lead operational excellence.
Basic Qualifications:
- High school/GED + 12 years Aseptic Manufacturing OR Associate’s + 10 years OR Bachelor’s + 8 years OR Master’s + 6 years OR Doctorate + 2 years.
- Minimum 2 years directly managing people and/or leading teams/projects/resources.
Preferred Qualifications:
- GMP/pharma environment experience (classified areas/gowning); chemistry-related degree.
- QC analytical chemistry operations (method transfer/qualification/validation/routine testing for biologics).
- Experience with deviations, CAPAs, change controls, regulatory documentation, data integrity, inspections.
- Strong communication; independent leadership; Lean/continuous improvement.
Benefits (Total Rewards):
- Health/welfare, retirement/savings, bonus (or sales incentive), stock incentives, time-off, flexible work models where possible.
Application Instructions:
- Apply via careers.amgen.com. No application deadline; sponsorship not guaranteed.
Responsibilities:
- Lead QC Chemistry laboratory and 1st/2nd shift Quality Control operations; oversee startup, operational readiness, and transition to steady-state commercial operations.
- Manage day-to-day QC Chemistry operations and 1st/2nd shift QC teams (7 days/week cross-functional night shift support).
- Lead analytical method transfer, qualification/validation, and routine testing.
- Support analytical method families: chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and compendial chemistry testing.
- Ensure compliance with safety guidelines, cGLPs, cGMPs, and applicable regulations.
- Build/coach/develop a high-performing QC organization; implement effective digital tools.
- Partner cross-functionally with Manufacturing, Process Development, QA, Facilities & Engineering, Supply Chain, and others.
- Support regulatory inspections and site licensure/inspection readiness.
- Drive Lean principles, establish goals/KPIs/staffing models for sustainable 24/7 operations, translate technical data to actionable insights, and lead operational excellence.
Basic Qualifications:
- High school/GED + 12 years Aseptic Manufacturing OR Associate’s + 10 years OR Bachelor’s + 8 years OR Master’s + 6 years OR Doctorate + 2 years.
- Minimum 2 years directly managing people and/or leading teams/projects/resources.
Preferred Qualifications:
- GMP/pharma environment experience (classified areas/gowning); chemistry-related degree.
- QC analytical chemistry operations (method transfer/qualification/validation/routine testing for biologics).
- Experience with deviations, CAPAs, change controls, regulatory documentation, data integrity, inspections.
- Strong communication; independent leadership; Lean/continuous improvement.
Benefits (Total Rewards):
- Health/welfare, retirement/savings, bonus (or sales incentive), stock incentives, time-off, flexible work models where possible.
Application Instructions:
- Apply via careers.amgen.com. No application deadline; sponsorship not guaranteed.