Sr Manager QC Microbiology

Amgen • Holly Springs, NC

8d

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience OR Associate’s degree and 10 years of Quality or Aseptic Manufacturing experience OR Bachelor’s degree and 8 years of Quality or Aseptic Manufacturing experience OR Master’s degree and 6 years of Quality or Aseptic Manufacturing experience OR Doctorate degree and 2 years of Quality or Aseptic Manufacturing experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

• Advanced degree in Microbiology, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline.
• Leadership experience within a GMP pharmaceutical, biotechnology, or aseptic manufacturing environment.
• Experience leading QC Microbiology, environmental monitoring, clean utilities monitoring, and/or molecular testing operations.
• Strong knowledge of microbiological control, aseptic technique, and cGMP requirements.
• Experience supporting regulatory inspections and interacting with regulatory agencies.
• Demonstrated ability to build, coach, and develop high-performing teams and future leaders.
• Strong scientific judgment and demonstrated ability to translate complex technical data into decisions and actions.
• Demonstrated success driving Lean, continuous improvement, digital transformation, or operational excellence.
• Strong collaboration, influencing, and communication skills, including the ability to work effectively across a global matrixed organization.
• Demonstrated ability to lead through change, challenge the status quo, and create sustainable improvements.

Responsibilities

• Lead the QC Microbiology organization with accountability for safety, quality, compliance, people, and operational performance.
• Provide oversight for environmental monitoring, clean utilities monitoring, microbial identification, PCR, and applicable in-process, release, stability, and routine microbiological testing.
• Build, coach, and develop a diverse, high-performing team while strengthening technical capability, succession, and career development.
• Ensure laboratory operations comply with cGMP requirements, applicable regulatory expectations, safety standards, and Amgen procedures.
• Provide leadership and technical oversight for investigations, deviations, CAPAs, change controls, trends, validation and qualification activities, methods, and laboratory systems.
• Represent QC Microbiology during regulatory inspections, audits, and other quality oversight activities.
• Maintain meaningful goals, KPIs, resource plans, and operating mechanisms that enable reliable laboratory performance.
• Use scientific and operational data to identify risk, inform decisions, and translate complex issues into clear actions.
• Advance Lean, digital, and continuous improvement approaches that improve laboratory reliability, efficiency, productivity, and cycle time while maintaining uncompromising quality.
• Partner across Quality, Manufacturing, Engineering, Regulatory, Technical Development, and the global Amgen QC network to solve complex problems and strengthen microbiological control strategies.
• Foster a culture where people speak up, challenge assumptions, collaborate across boundaries, and take ownership for results.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED