Senior Manager: Manufacturing- Downstream Bulk Drug Substance

Amgen SA; Holly Springs (NC); On-site; USD 160,000 - 220,000; Full time

Job summary

Amgen is seeking a Senior Manager of Manufacturing - Downstream Bulk Drug Substance to lead 24/7 downstream purification operations at a new facility. You will partner with engineering, quality, automation, and process development to execute commissioning, qualification, and GMP startup activities.

You will coach Front-Line Managers, design organizational structure, and ensure staff are trained and qualified per procedures and readiness requirements for sustained manufacturing performance.

Qualifications

• Doctorate/Master/Bachelor in a science or engineering field with manufacturing experience.
• Experience in GMP drug substance manufacturing and startup environments.
• Strong leadership and mentoring capabilities for 24/7 operations.
• Proven ability to lead commissioning, qualification, and handover activities.

Responsibilities

• Develop and retain a high-performing team aligned with startup and GMP goals.
• Lead safety and quality culture and drive continuous improvement.
• Collaborate with Quality, Engineering, Process Development and Supply Chain.
• Provide technical leadership for deviations, CAPAs, and investigations.
• Oversee downstream chromatography packing activities and readiness for operations.
• Guide commissioning and qualification activities and equipment turnover.
• Plan workforce, training, and readiness for facility start-up.

Skills

Leadership

Manufacturing Operations

GMP Compliance

Downstream Purification

Commissioning & Qualification

Staff Development

Project Management

Cross-Functional Collaboration

Education

Doctorate in a relevant field

Master's degree in a relevant field

Bachelor's degree in a related field

Associate degree in a related field

High School diploma

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 single use 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 establishes 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 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

• 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.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a collaborative partner with these 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

AND2 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 manufacturingdrug substanceplant

• 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

Thrive

What you can expect of us

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

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.