Senior Manager: Manufacturing - Downstream Bulk Drug Substance
Amgen
August 19, 2026
On-site
Holly Springs, NC
Operations
Senior Manager: Manufacturing – Downstream Bulk Drug Substance
What You Will Do
- Provide leadership and guidance for 24/7 downstream purification manufacturing operations.
- Enable commissioning, qualification, start-up, and GMP operation of a new drug substance manufacturing facility; coach and develop Downstream Front-Line Managers.
- Accountable for manufacturing team organizational design: workforce planning, hiring, onboarding, training, qualification, and staff development.
- Provide oversight for downstream C&Q for process systems, equipment, utilities, and infrastructure; partner with Engineering, Quality, Automation, Validation, Process Development, and project teams to review designs, protocols, acceptance criteria, and documentation.
- Ensure participation in design reviews, system walkdowns, factory/site acceptance testing, commissioning execution, equipment qualification, process demonstrations, water/engineering runs, and performance qualification.
- Lead operational readiness and transition to routine GMP: readiness plans, standard work, training/qualification, shift structures, materials/equipment availability, and system readiness.
- Establish/monitor readiness metrics, risks, dependencies, and action plans; ensure handover of qualified systems and implement ownership, performance monitoring, troubleshooting, preventive maintenance coordination, and continuous improvement.
- Accountable for sustained downstream manufacturing performance (safety, quality, compliance, schedule, reliability, workforce capability, continuous improvement).
Responsibilities
- Develop and retain a high-performing, diverse team; champion safety and quality culture.
- Collaborate with Quality, Process Development, Engineering, Supply Chain, and partners.
- Troubleshoot and resolve issues; manage 24/7 call coverage.
- Provide technical leadership for deviation investigations and CAPAs.
- Lead downstream chromatography column packing planning/execution/qualification/documentation.
- Lead/support regulatory inspections and develop inspection playbooks.
- Deliver financial commitments while championing lean.
What We Expect of You
Basic Qualifications
- Doctorate + 2 years Manufacturing & Operations OR Master’s + 6 years OR Bachelor’s + 8 years OR Associate’s + 10 years OR High school/GED + 12 years
- 2 years managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
Preferred Qualifications
- GMP drug substance plant managerial experience.
- Operational Excellence and Lean manufacturing experience.
- Cross-functional experience in Process Development, Quality, or Engineering.
- Excellent communication, urgency, energy, and problem-solving.
- Ability to build and maintain cross-functional relationships.
- Ability to develop/coach staff and advance organizational culture.
What You Will Do
- Provide leadership and guidance for 24/7 downstream purification manufacturing operations.
- Enable commissioning, qualification, start-up, and GMP operation of a new drug substance manufacturing facility; coach and develop Downstream Front-Line Managers.
- Accountable for manufacturing team organizational design: workforce planning, hiring, onboarding, training, qualification, and staff development.
- Provide oversight for downstream C&Q for process systems, equipment, utilities, and infrastructure; partner with Engineering, Quality, Automation, Validation, Process Development, and project teams to review designs, protocols, acceptance criteria, and documentation.
- Ensure participation in design reviews, system walkdowns, factory/site acceptance testing, commissioning execution, equipment qualification, process demonstrations, water/engineering runs, and performance qualification.
- Lead operational readiness and transition to routine GMP: readiness plans, standard work, training/qualification, shift structures, materials/equipment availability, and system readiness.
- Establish/monitor readiness metrics, risks, dependencies, and action plans; ensure handover of qualified systems and implement ownership, performance monitoring, troubleshooting, preventive maintenance coordination, and continuous improvement.
- Accountable for sustained downstream manufacturing performance (safety, quality, compliance, schedule, reliability, workforce capability, continuous improvement).
Responsibilities
- Develop and retain a high-performing, diverse team; champion safety and quality culture.
- Collaborate with Quality, Process Development, Engineering, Supply Chain, and partners.
- Troubleshoot and resolve issues; manage 24/7 call coverage.
- Provide technical leadership for deviation investigations and CAPAs.
- Lead downstream chromatography column packing planning/execution/qualification/documentation.
- Lead/support regulatory inspections and develop inspection playbooks.
- Deliver financial commitments while championing lean.
What We Expect of You
Basic Qualifications
- Doctorate + 2 years Manufacturing & Operations OR Master’s + 6 years OR Bachelor’s + 8 years OR Associate’s + 10 years OR High school/GED + 12 years
- 2 years managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
Preferred Qualifications
- GMP drug substance plant managerial experience.
- Operational Excellence and Lean manufacturing experience.
- Cross-functional experience in Process Development, Quality, or Engineering.
- Excellent communication, urgency, energy, and problem-solving.
- Ability to build and maintain cross-functional relationships.
- Ability to develop/coach staff and advance organizational culture.