Senior Manufacturing Manager - Downstream

Amgen • Holly Springs, NC

3d

About The Position

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 FleX Batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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. 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.

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 Haves

• 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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED