Sr Manager QC Microbiology

Career Category Quality Job Description 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. SR MANAGER QC MICROBIOLOGY What you will do 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. How you will lead: At Amgen, leadership is defined by both what we accomplish and how we accomplish it . As a Senior Manager, you will model Amgen’s values and leadership attributes in how you lead your organization, make