Senior Manager: Manufacturing- Downstream Bulk Drug Substance

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. 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 single-use 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.

About the role

As 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, you will collaborate cross-functionally to enable the commissioning, qualification, start-up, and GMP operation of a new drug substance manufacturing facility. This role is responsible for coaching and developing Downstream Front-Line Managers who oversee staff supporting direct drug substance production. You will be accountable for the organizational design of the manufacturing team, including workforce planning, hiring, onboarding, training, qualification, and development of staff to support safe, reliable, and compliant operations.

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 with 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.
• Provide leadership and oversight for downstream chromatography column packing activities, including planning, execution, qualification, troubleshooting, documentation, and readiness to support reliable GMP manufacturing operations.
• Lead and support regulatory inspections for areas of responsibility, including evaluating complex compliance issues and developing playbooks for the inspections.
• Deliver against organizational financial commitments while championing a lean philosophy.
• Provide Manufacturing leadership and support for Commissioning and Qualification activities, including design reviews, system walkdowns, protocol execution, issue resolution, and equipment turnover.
• Lead operational readiness activities for downstream manufacturing, including procedures, training, staffing, materials, system ownership, and readiness assessments to support successful facility start-up and transition to GMP operations.
• Ensure personnel are appropriately trained and qualified in accordance with established training programs, procedures, and operational readiness requirements.
• Provide leadership and manufacturing oversight for Commissioning and Qualification activities associated with downstream process systems, equipment, utilities, and supporting infrastructure.
• Partner with Engineering, Quality, Automation, Validation, Process Development, and project teams to review system designs, commissioning and qualification protocols, acceptance criteria, turnover packages, and supporting documentation to confirm that systems are safe, compliant, maintainable, and operationally ready.
• Ensure appropriate Manufacturing participation in design reviews, system walkdowns, factory and site acceptance testing, commissioning execution, equipment qualification, process demonstrations, water runs, engineering runs, and performance qualification activities.
• Support the identification, documentation, escalation, and resolution of equipment, process, automation, and facility issues identified during C&Q and start-up.
• Establish and monitor readiness metrics, risks, dependencies, and action plans, ensuring that gaps are identified early, assigned to accountable owners, and resolved in alignment with project and manufacturing milestones.
• Ensure effective handover of qualified systems from the project organization to Manufacturing and establish sustainable processes for equipment ownership, system performance monitoring, troubleshooting, preventive maintenance coordination, and continuous improvement.
• Following facility start-up, be accountable for sustained manufacturing performance, including safety, quality, compliance, schedule adherence, operational reliability, workforce capability, and continuous improvement across downstream purification operations.

Qualifications

Basic Qualifications

• Doctorate degree and 2 years of Manufacturing & Operations experience
• Or Master’s degree and 6 years of Manufacturing & Operations experience
• Or Bachelor’s degree and 8 years of Manufacturing & Operations experience
• Or Associate’s degree and 10 years of Manufacturing & Operations experience
• Or High School diploma/GED and 12 years of Manufacturing & Operations experience
• AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• 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

Benefits

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• 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