**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. 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. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Manager Manufacturing MES and Finite Scheduling** **What you will do** Let’s do this. Let’s change the world. In this vital role you will act as the Manufacturing Execution Systems (MES) and Finite Scheduling Manager for GMP Drug Substance Supply (DSS). This position is within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization. ANC is a dynamic environment and an important supply facility for Amgen’s pipeline products. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. The MES/Finite team is a key communication and technical interface function between the GMP manufacturing operations teams and NPI, Supply Chain, Facilities & Engineering, and Process Development. The manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering on short- and long-term Amgen Operational goals. + Oversees the site finite production schedule and MES activities. + Assists in developing and maintaining department goals. + Leads the troubleshooting, problem solving and RCAs associated with MES. Develop and own countermeasures to prevent error recurrence. + Facilitates the drive towards continuous improvement and data digitization in the plant. Leads integration with data management tools. + Collaborates with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings associated with MES in the plant. + Represents the plant on global MES and finite schedule network initiatives. + Evaluates and implements process improvements and optimizations, partnering with Quality, compliance, and EHSS (Environmental, Health, Safety and Sustainability) on change controls + Interacts with regulatory agencies as needed. + Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement. + Responsible for selection, training, evaluation, staff relations and staff development. + Mentors and coaches staff members to live by the Amgen Values. + Develops and implements training plans and programs, to ensure staff are prepared and compliant. + Ensures adherence to production schedule and maintenance activities. + Interacts with management in optimizing organizational structure and responsibilities. + Demonstrate technical mastery of manufacturing processes. + Collaborate with cross-functional teams (i.e., QA/QC, F&E (Facilities & Engineering), Mfg, PD (Process Development), Regulatory, etc.) in completing activities that support manufacturing operations. + Develop, implement, and assess CAPAs (Corrective Action Preventive Action) and solutions to complex problems. + Interacts with management in planning, developing, and maintaining budget. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. **Basic Qualifications:** + High school diploma / GED and 12 years of Manufacturing and/or operations experience OR + Associate degree and 10 years of Manufacturing and/or operations experience OR + Bachelor’s degree and 5 years of Manufacturing and/or operations experience OR + Master’s degree and 3 years of Manufacturing and/or operations experience OR + Doctorate degree + **And** in addition to meeting at least one of the above requirements, you must have 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 **Preferred Qualifications:** + Bachelor’s degree in Life Sciences or Engineering + Experience in biotechnology or pharmaceutical plant start up + Basic understanding of upstream and/or downstream operations + Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources + Knowledge and experience within a cGMP or other highly regulated environment + 5 years process experience in a cGMP manufacturing facility + 3+ years of experience in a production Area Lead, Specialist or Manager role + Strong leadership and teambuilding skills (coaching, mentoring, counseling) + Experience with performance management including performance reviews + Conflict Resolution, analytical problem solving, and project management skills + Thorough understanding of regulatory requirements + Excellent verbal and written communication (technical) skills + Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems + Extensive experience with electronic documentation systems in a regulated environment + Experience with PAS X, Werum, (or other finite scheduling tool) + Experience with Electronic Batch Record (EBR)/Manufacturing Execution Systems (MES) + Experience in GMP operations + Technical knowledge of biotechnology cell culture and drug substance purification operations + Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms + Ability to coach, mentor and/or cross train colleagues within core technical areas + Background in lean manufacturing methodologies and operational excellence + Experience in cross-functional Project Management **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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.