Sr Manager QC Microbiology

Let’s do this. Let’s change the world. In this vital role you will lead the Quality Control Microbiology organization at Amgen’s advanced biomanufacturing site in Holly Springs, North Carolina. You will be responsible for the performance and development of a diverse team supporting QC Microbiology and PCR laboratory operations and will play an important role in ensuring the reliable delivery of medicines to patients. As a member of the Quality Control leadership team, you will provide strategic, technical, and operational leadership across environmental monitoring, clean utilities monitoring, microbial identification, PCR, and microbiological product testing. This is an opportunity for a strong people and technical leader to shape the future of microbiology at the site—building organizational capability, strengthening laboratory performance, developing talent, and advancing innovation and operational excellence.

• 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.

• 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

• 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.

What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.