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Amgen

Manager - Manufacturing Services

Amgen, Holly Springs, North Carolina


Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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 single use 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 Services What you will do Lets do this. Lets change the world. In this vital role you will provide leadership and guidance to the team responsible for 24/7 manufacturing operations in the Manufacturing Services area, which includes the following responsibilities: Raw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, and Autoclave. As a member of the Manufacturing leadership team you will work hand in hand with a multidisciplinary team to deliver robust equipment, procedures, and processes to operate the new plant. This includes organizational design, hiring, and training of the staff required to support start up and operations of the plant and oversight of operational readiness initiatives for the area. Build, develop, and retain a diverse and impactful team in alignment with operational readiness schedules to ensure successful start up and transition to GMP operations Be responsible for the safety and quality culture of the department and champion continued improvement Effectively collaborate with manufacturing support groups (Quality, Process Development, Engineering, Supply Chain, and network partners) Provide support to troubleshoot, identify, and resolve issues as needed and lead call coverage for 24/7 operation Provide technical leadership for the investigation of deviations and the development of corrective actions Align with the broader organizational strategy and deliver continuous improvement Support regulatory inspections for areas of responsibilities including evaluating complex compliance issues and developing playbooks for the inspections Deliver against organizational financial commitments while championing a lean philosophy What we expect of you We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a collaborative partner with these qualifications. Basic Qualifications: High School diploma/GED and 12 years of Manufacturing & Operations experience OR Associate's degree and 10 years of Manufacturing & Operations experience OR Bachelors degree and 5 years of Manufacturing & Operations experience OR Masters degree and 3 years of Manufacturing & 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: Proven managerial experience in a GMP manufacturing drug substance plant Proven experience in applying Operational Excellence and Lean Manufacturing Cross-functional work experience in either Process Development, Quality or Engineering Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities Demonstrated ability to forge and maintain strong relationships with other functional areas Ability to optimally develop and mentor staff and positively advance the culture of an organization 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, well 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.