Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Night Shift
Amgen
August 21, 2026
On-site
Holly Springs, NC
Operations
Manager Manufacturing (Downstream) – Night Shift
What You Will Do
- On-shift front line manager in manufacturing supporting 24/7 GMP drug substance operations; 12-hour 2-2-3 schedule (5:45pm–6:15am).
- Oversee manufacturing associate teams responsible for GMP drug substances; champion safe, compliant production in a Lean/continuous improvement culture.
- Define area objectives, identify improvement opportunities, lead change efforts, and deliver short- and long-term operational goals.
- Coach, hire, mentor, and develop staff; build relationships and drive team performance.
- Ensure safe working environment and compliance with cGMP and CFR requirements; evaluate operating procedures and recommend optimizations.
- Support corporate change control; notify Regulatory/QA; interact with regulatory agencies as needed.
- Assure proper gowning/aseptic techniques; maintain training programs and adherence to production and maintenance schedules.
- Demonstrate technical mastery; oversee critical manufacturing process/task execution.
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.).
- Develop/assess CAPAs and resolve daily operational issues.
What We Expect From You
Basic Qualifications
- Doctorate OR Master’s + 3 years manufacturing/operations OR Bachelor’s + 5 years OR Associate’s + 10 years OR HS/GED + 12 years; AND prior managerial experience directly managing people and/or leading teams/projects/programs/resources.
Preferred Qualifications
- Life Sciences/Engineering degree; biotechnology/pharma plant start-up; downstream purification (Column Chromatography, TFF, Viral Filtration, Viral Inactivation); cGMP experience (5+ years); 3+ years in Area Lead/Specialist/Manager role.
- Strong leadership/teambuilding, performance management, conflict resolution, analytical problem solving, project management.
- Regulatory understanding; technical communication; Microsoft/EBR-MES/DeltaV/electronic quality systems.
Total Rewards (U.S.)
- Health/welfare, retirement and savings, life/disability, flexible spending; discretionary annual bonus; stock-based incentives; time-off/shutdowns; flexible work models (where possible).
Apply
- Apply via careers.amgen.com.
What You Will Do
- On-shift front line manager in manufacturing supporting 24/7 GMP drug substance operations; 12-hour 2-2-3 schedule (5:45pm–6:15am).
- Oversee manufacturing associate teams responsible for GMP drug substances; champion safe, compliant production in a Lean/continuous improvement culture.
- Define area objectives, identify improvement opportunities, lead change efforts, and deliver short- and long-term operational goals.
- Coach, hire, mentor, and develop staff; build relationships and drive team performance.
- Ensure safe working environment and compliance with cGMP and CFR requirements; evaluate operating procedures and recommend optimizations.
- Support corporate change control; notify Regulatory/QA; interact with regulatory agencies as needed.
- Assure proper gowning/aseptic techniques; maintain training programs and adherence to production and maintenance schedules.
- Demonstrate technical mastery; oversee critical manufacturing process/task execution.
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.).
- Develop/assess CAPAs and resolve daily operational issues.
What We Expect From You
Basic Qualifications
- Doctorate OR Master’s + 3 years manufacturing/operations OR Bachelor’s + 5 years OR Associate’s + 10 years OR HS/GED + 12 years; AND prior managerial experience directly managing people and/or leading teams/projects/programs/resources.
Preferred Qualifications
- Life Sciences/Engineering degree; biotechnology/pharma plant start-up; downstream purification (Column Chromatography, TFF, Viral Filtration, Viral Inactivation); cGMP experience (5+ years); 3+ years in Area Lead/Specialist/Manager role.
- Strong leadership/teambuilding, performance management, conflict resolution, analytical problem solving, project management.
- Regulatory understanding; technical communication; Microsoft/EBR-MES/DeltaV/electronic quality systems.
Total Rewards (U.S.)
- Health/welfare, retirement and savings, life/disability, flexible spending; discretionary annual bonus; stock-based incentives; time-off/shutdowns; flexible work models (where possible).
Apply
- Apply via careers.amgen.com.