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HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleXBatch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Manager: Manufacturing Live What you will do Let’s do this. Let’s change the world. As a Senior Manager of Manufacturing, you will provide leadership and guidance to the team responsible for 24/7 manufacturing operations in downstream purification. In this vital role as a member of the Manufacturing leadership team, the Sr. Manager of Manufacturing will collaborate cross-functionally to enable the GMP to manufacture drug substance in a new manufacturing facility. This role is responsible for coaching and developing Downstream Front-Line Managers who oversee staff supporting direct drug substance production. Additionally, you will be accountable for organizational design of the manufacturing team, hiring and development of staff, and ensure staff is compliant with training programs to support safe and reliant operations. The position will also provide leadership and oversight for operational readiness activities to ensure successful facility start-up and sustained manufacturing performance.
Job Responsibility:
Develop and retain a diverse and high performing team in alignment with operational readiness schedules to ensure successful startup and commercial GMP operations
Mature the site's safety and quality culture of the department and champion continued improvement
Collaborate as one team of all manufacturing support groups (Quality, Process Development, Engineering, Supply Chain, and network partners)
Provide support to troubleshoot, identify, and resolve issues as needed and manage call coverage for 24/7 operation
Provide technical leadership for the investigation of deviations and the development of corrective actions
Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy and deliver continuous improvement
Lead and 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
Requirements:
Doctorate degree and 2 years of Manufacturing & Operations experience
Master's degree and 6 years of Manufacturing & Operations experience
Bachelor's degree and 8 years of Manufacturing & Operations experience
Associate's degree and 10 years of Manufacturing & Operations experience
High School diploma/GED and 12 years of Manufacturing & Operations experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Nice to have:
Demonstrated managerial experience in a GMP manufacturing drug substance plant
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 we offer:
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits