Sr Manager QC Microbiology
Amgen
August 25, 2026
On-site
Holly Springs, NC
Operations
SR MANAGER QC MICROBIOLOGY
What You Will Do
- Lead the QC Microbiology organization (safety, quality, compliance, people, operational performance).
- Oversee environmental monitoring, clean utilities monitoring, microbial identification, PCR, and in-process/release/stability/routine microbiological testing.
- Build/coach/develop a diverse, high-performing team; strengthen technical capability, succession, and career development.
- Ensure lab operations comply with cGMP, regulatory expectations, safety standards, and Amgen procedures.
- Lead/oversee investigations, deviations, CAPAs, change controls, trends, validation/qualification, methods, and lab systems.
- Represent QC Microbiology in regulatory inspections/audits.
- Set goals, KPIs, resource plans, and operating mechanisms for reliable performance.
- Use data to identify risk and translate complex issues into actions.
- Advance Lean/digital/continuous improvement to improve reliability, efficiency, productivity, and cycle time.
- Partner cross-functionally and globally to strengthen microbiological control strategies.
Qualifications
Basic Qualifications:
- High school/GED + 12 years Quality or Aseptic Manufacturing, OR Associate’s + 10 years, OR Bachelor’s + 8 years, OR Master’s + 6 years, OR Doctorate + 2 years.
- Minimum 2 years managing people and/or leading teams/projects/programs/resources.
Preferred Qualifications:
- Advanced degree in Microbiology/Molecular Biology/Pharmaceutical Sciences or related.
- Leadership in GMP/pharma/biotech/aseptic environment.
- Experience leading QC Microbiology and/or environmental monitoring/clean utilities/molecular testing.
- Knowledge of microbiological control, aseptic technique, and cGMP.
- Regulatory inspection experience; strong team development; scientific judgment; Lean/continuous improvement/digital transformation; collaboration across global teams.
Benefits (as stated)
- Retirement/Savings plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient candidates or selection.
What You Will Do
- Lead the QC Microbiology organization (safety, quality, compliance, people, operational performance).
- Oversee environmental monitoring, clean utilities monitoring, microbial identification, PCR, and in-process/release/stability/routine microbiological testing.
- Build/coach/develop a diverse, high-performing team; strengthen technical capability, succession, and career development.
- Ensure lab operations comply with cGMP, regulatory expectations, safety standards, and Amgen procedures.
- Lead/oversee investigations, deviations, CAPAs, change controls, trends, validation/qualification, methods, and lab systems.
- Represent QC Microbiology in regulatory inspections/audits.
- Set goals, KPIs, resource plans, and operating mechanisms for reliable performance.
- Use data to identify risk and translate complex issues into actions.
- Advance Lean/digital/continuous improvement to improve reliability, efficiency, productivity, and cycle time.
- Partner cross-functionally and globally to strengthen microbiological control strategies.
Qualifications
Basic Qualifications:
- High school/GED + 12 years Quality or Aseptic Manufacturing, OR Associate’s + 10 years, OR Bachelor’s + 8 years, OR Master’s + 6 years, OR Doctorate + 2 years.
- Minimum 2 years managing people and/or leading teams/projects/programs/resources.
Preferred Qualifications:
- Advanced degree in Microbiology/Molecular Biology/Pharmaceutical Sciences or related.
- Leadership in GMP/pharma/biotech/aseptic environment.
- Experience leading QC Microbiology and/or environmental monitoring/clean utilities/molecular testing.
- Knowledge of microbiological control, aseptic technique, and cGMP.
- Regulatory inspection experience; strong team development; scientific judgment; Lean/continuous improvement/digital transformation; collaboration across global teams.
Benefits (as stated)
- Retirement/Savings plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient candidates or selection.