Senior Manager: Manufacturing - Downstream Bulk Drug Substance

About this role

Career Category Manufacturing Job Description 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  FleX  Batch facility combines the latest in   s ingle   u se   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.   

Senior Manager: Manufacturing   - Downstream   Bulk Drug Substance

Live      

What you  will do      

Let’s   do this.   Let’s   change the world. 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, the Senior Manager of Manufacturing 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.  

The Senior Manager 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. The role will ensure that personnel are appropriately trained and qualified   in accordance with   established training programs, procedures, and operational readiness requirements.  

The position will provide leadership and manufacturing oversight for Commissioning and Qualification activities associated with downstream process systems, equipment, utilities, and supporting infrastructure. Responsibilities will include partnering 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.  

The Senior Manager will 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. The role will also support the identification, documentation, escalation, and resolution of equipment, process, automation, and facility issues   identified   during C&Q and start-up. The position will also provide leadership and oversight for downstream chromatography column packing activities to ensure readiness for reliable GMP operations.  

Additionally, the Senior Manager will lead operational readiness activities   required   for successful facility start-up and transition to routine GMP manufacturing. This includes development and execution of readiness plans, establishment of operating procedures and standard work, completion of training and qualification activities, confirmation of materials and equipment availability, implementation of shift structures, and verification that manufacturing systems and support processes are prepared for operation.

The position will   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. The Senior Manager will also 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, the Senior Manager will be accountable for sustained manufacturing performance, including safety, quality, compliance, schedule adherence, operational reliability, workforce capability, and continuous improvement across downstream purification 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 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 operatio n  

• 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 f

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