Mgr Manufacturing - Nights

Job description

Career CategoryOperationsJob DescriptionJoin 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. Manager Manufacturing PPH - Nights What you will do Let’s do this. Let’s change the world. In this vital role, you will lead front-line manufacturing operations within AR5 PPH, supporting upstream cell culture activities including perfusion, production, and harvest operations. You will be accountable for safe, compliant, reliable, and right-first-time execution of the manufacturing plan while building a high-performing team that consistently demonstrates Amgen’s “Every Action, Every Time” culture. The Front-Line Manager will collaborate routinely with Quality Assurance, Quality Control, Engineering, Facilities and Engineering, Maintenance, Process Development, Process Engineering, Supply Chain, Regulatory Compliance, and other site functions. This role requires strong technical ownership of manufacturing operations, disciplined execution of cGMP and safety expectations, and the ability to make timely decisions in a dynamic production environment. With minimal direction, the Manager is responsible for leading on-the-floor operations and staff in manufacturing. The Manager will supervise, coach, hire, onboard, and develop manufacturing staff while ensuring that team members are trained, capable, engaged, and prepared to meet production requirements. The Front-Line Manager will help define area objectives, identify improvement opportunities, lead change efforts, and deliver against short- and long-term AR5 manufacturing goals. This leader will be expected to strengthen reliability, improve operational efficiency, enable agility for future business needs, and support AR5’s commitment to being the best place for talent. Scope of Responsibility Lead on-the-floor execution of AR5 PPH upstream manufacturing operations, including perfusion, production, and harvest activities. Demonstrate technical mastery of cell culture processes, equipment, systems, and operational requirements. Oversee right-first-time execution of the production plan in alignment with cGMP, safety, quality, and operational standards. Provide daily oversight of cGMP practices and safety programs to reduce human error events and strengthen operational discipline. Ensure adherence to Standard Operating Procedures, batch records, electronic batch records, GMP requirements, safety standards, and site procedures. Ensure the manufacturing area remains inspection-ready at all times through strong housekeeping, audit readiness, and routine area ownership. Drive reduction in housekeeping and inspection-readiness observations by ensuring timely correction of gaps and sustained adherence to standards. Lead or support housekeeping audits, inspection-readiness mock audits, area walkthroughs, and readiness activities. Coach staff on proper use of error-prevention behaviors before, during, and after manufacturing execution. Troubleshoot process deviations, equipment issues, material constraints, and operational challenges in real time. Make sound processing decisions using technical knowledge, procedural requirements, quality expectations, and business priorities. Participate in investigations, deviations, CAPAs, audits, and regulatory inspections as the manufacturing operations owner or representative. Ensure clear, timely, and effective communication across shifts, functions, and levels of the organization. Ensure appropriate scheduling and coordination of production, maintenance, cleaning, turnover, training, and support activities. Collaborate with QA, QC, F&E, Maintenance, PD, Process Engineering, Supply Chain, Regulatory, and other partners to complete production activities and maintain schedule adherence. Monitor area performance and drive improvements in safety, quality, compliance, reliability, throughput, and efficiency Leading Strategy Development and Execution Assist in developing and implementing departmental strategy and plans aligned with broader AR5, ARI, and site manufacturing objectives. Translate strategic priorities into clear daily, weekly, and shift-level execution plans. Anticipate operational, quality, safety, training, and schedule risks and build contingencies to reduce impact. Deliver strong business results through continuous improvement, standardization, and disciplined execution. Use metrics, audit outcomes, process data, and staff feedback to identify trends and improve performance. Lead change efforts that improve safety, compliance, quality, efficiency, throughput, and reliability. Ensure the team understands how daily execution connects to Amgen’s mission, patient impact, and AR5 business priorities. Building a Strong Organizational Alignment Be responsible for selection, onboarding, training, evaluation, staff relations, performance management, and development of manufacturing staff. Ensure the right people, skills, and resources are in place and optimally allocated to achieve production, quality, and business goals. Interact with management to optimize organizational structure, roles, responsibilities, and shift performance. Build and develop a diverse, impactful team that can reliably execute complex manufacturing operations. Work across functions to build organizational and individual capability. Develop strong relationships with staff members and provide open, clear, and actionable feedback. Foster a team environment that supports accountability, innovation, continuous improvement, learning, knowledge-sharing, and psychological safety. Promote clear communication across shifts to ensure continuity, alignment, and readiness. Lead with a people-centered approach that supports engagement, retention, empowerment, and development. The on-boarding phase for this role will last 2-6 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7pm -7am (D shift) with a two-week rotation covering 7 days per week. The rotating shift offers several benefits such as, an average of 14 days on shift per month with every other weekend off and receiving an added 15% shift differential. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative leader with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Manufacturing and Operations experience OR Associate’s degree and 10 years of Manufacturing and Operations experience OR Bachelor’s degree and 5 years of Manufacturing and Operations experience OR Master’s degree and 3 years of Manufacturing and Operations experience OR Doctorate degree In addition to meeting at least one of the above requirements, you must ha