West Greenwich, RI, 02817, USA
10 days ago
Manager Manufacturing Support
**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. **Manager Manufacturing Support - Single-Use Manufacturing Facility** **What you will do** Let’s do this. Let’s change the world. In this vital role you will be responsible for managing the life cycle and day to day production support requirements associated with the products and process equipment for our Amgen Rhode Island AR30 manufacturing facility. This leadership role at ARI's AR30 Single-Use Manufacturing Facility provides technical oversight for the manufacturing process support team responsible for transforming the business through capacity increase and new product introductions, including operations associated with I-530. This position is critical to the advancement of AR30’s capabilities and capacity as we continue to scale up production and enable innovation within Amgen’s manufacturing network. The Manager will have technical leadership for operations tied to I-530, a transformative model that integrates production scalability and efficiency from both AR5 and AR30 plants. This includes driving the implementation of process enhancements and new product introductions, while also addressing capacity challenges through innovative resource and capacity management solutions. I-530’s integration has unlocked significant manufacturing efficiencies, enabling multi-scale production and rapid adaptability to meet growing demands. **Responsibilities include:** + Safety and Quality Oversight: Ensure safety and quality standards are upheld for the manufacturing of biologics providing technical support for upstream, downstream, and solution prep in AR30 manufacturing, including I-530 operations. + I-530 Operations Leadership: Provide technical expertise and oversight to I-530 activities, leveraging its capability to optimize manufacturing scalability across AR30 and AR5. Drive alignment on capacity utilization and resource deployment for increased efficiency. + Talent Development: Mentor and develop manufacturing experts, fostering an environment of continuous learning and operational excellence. Build, develop and retain a diverse and high performing team, including coaching and developing staff towards their fullest potential to support an engaged motivated workforce. + Innovation and Process Enhancement: Drive process transformation initiatives to support higher efficiency and eliminate non-value-added activities. Lead operational readiness for process enhancements, including innovative changeover and scheduling solutions. Responsible for product lifecycle management and associated procedures, including all new product introductions and product re-introductions into the plant. + Network Collaboration: Collaborate cross-functionally with F&E, PD, Quality, EHSS, QC, and other stakeholders to ensure alignment on strategic objectives and key milestones. + Capacity and Financial Planning: Perform resource planning, financial assessments, and capacity modeling, ensuring AR30 manufacturing can meet the evolving needs of the long-range manufacturing plan. + Continuous Improvement: Lead initiatives to reduce deviations, improve success rates, and maintain high adherence to disposition timelines. Champion the adoption of innovative tools such as digital control solutions and real-time operational oversight platforms. + Sustainability Leadership: Contribute to achieving AR30’s sustainability goals through process optimizations that reduce waste and energy consumption. + Sitewide Collaboration: Effectively collaborate with key customers and support groups (Manufacturing, Quality, Process Development, Engineering, and network partners) and drive new business processes to ensure continuous and sustained improvement. + Technical Leadership and Issue Resolution: Provide technical support to troubleshoot, identify and resolve process and system issues as needed and manage call coverage for 24/7 operation. Manage change controls, corrective actions and preventative actions associated with products and process equipment. Own and lead investigations associated with process deviations and non-conformances. + Ensure Quality: Lead and support regulatory inspections for areas of responsibilities including develop playbooks for the inspections. **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 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 + Bachelor’s degree and 5 years of Manufacturing & Operations experience OR + Master’s degree and 3 years of Manufacturing & Operations experience OR + Doctorate degree 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, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above. **Preferred Qualifications:** + Demonstrated managerial experience in a GMP manufacturing plant, preferably a drug substance plant and mammalian cell culture. + Demonstrated 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 effectively develop and coach 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, 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, including remote and hybrid work arrangements, where possible **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Application deadline** Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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.
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