Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Day Shift

Amgen; Holly Springs (NC); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus program

Flexible work models

Stock-based long-term incentives

Job summary

Amgen is looking for a Manager of Manufacturing to oversee teams responsible for GMP drug substance production at our Holly Springs facility. This 12-hour day shift role requires strong leadership and technical skills in biotechnology production operations.

The ideal candidate will have a doctorate or a degree with substantial experience in manufacturing and a proven ability to foster a safe and compliant environment. The position offers a comprehensive benefits package and opportunities for career development.

Qualifications

• Doctorate degree or equivalent with significant relevant experience.
• Previous managerial experience directly managing people.
• Experience in a cGMP environment preferred.

Responsibilities

• Oversee teams of manufacturing associates responsible for GMP drug substance production.
• Champion a safe and compliant production environment.
• Collaborate with cross-functional teams to resolve daily operational problems.

Skills

Leadership skills

Technical understanding of biotechnology production

Analytical problem-solving

Conflict resolution

Education

Doctorate degree

Master's degree with 3 years of Manufacturing or Operations experience

Bachelor's degree with 5 years of Manufacturing or Operations experience

Associate's degree with 10 years of Manufacturing or Operations experience

High school diploma / GED with 12 years of Manufacturing or Operations experience

Tools

Microsoft Office

EBR/MES

Delta V

Electronic quality systems

Job description

The Amgen FleX Batch facility combines the latest in disposable technologies with traditional stainless‑steel equipment, enabling maximum flexibility and sustainable innovations to reduce carbon and waste.

Manager Manufacturing (Downstream) – Day Shift

This role supports critical 24/7 manufacturing operations and works a 12‑hour 2‑2‑3 schedule from 5:45am to 6:15pm.

What You Will Do

• Oversee teams of manufacturing associates responsible for GMP drug substance production.
• Champion a safe and compliant production environment and embed Lean and continuous improvement principles.
• Coach, hire and mentor staff, supporting their professional development.
• Define area objectives, identify improvement opportunities and lead change efforts.

Compliance

• Ensure a safe working environment and adherence to Amgen policies, cGMP and CFR compliance.
• Evaluate operating procedures, recommend changes to management to optimize production.
• Ensure corporate change control procedures are followed, and regulatory and QA are notified prior to changes.
• Interact with regulatory agencies as needed.
• Maintain proper gowning and aseptic techniques.

Staff Supervision

• Engage staff and build trustful relationships while driving performance and continuous improvement.
• Recruit, train, evaluate, coach and develop staff.
• Mentor and coach staff to live by Amgen values.
• Develop and implement training plans and programs to ensure compliance.
• Ensure adherence to production schedule and maintenance activities.
• Collaborate with management to optimize organizational structure and responsibilities.
• Audit plant safety and conduct cross‑functional walks.
• Maintain gowning and aseptic techniques training programs.

Process/Equipment/Facilities

• Demonstrate technical mastery of manufacturing processes.
• Collaborate with cross‑functional teams (e.g., QA/QC, F&E, PPIC, Mfg, PD, Regulatory).
• Develop, implement, and assess CAPAs and solutions to complex problems.
• Resolve problems during daily operations.
• Oversee setup, execution, and completion of critical manufacturing processes and tasks.

Administrative

• Plan, develop, and maintain budget in collaboration with management.
• Assist in developing and maintaining department goals.

What We Expect From You

Basic Qualifications

• Doctorate degree
• Master’s degree with 3 years of Manufacturing or Operations experience
• Bachelor’s degree with 5 years of Manufacturing or Operations experience
• Associate’s degree with 10 years of Manufacturing or Operations experience
• High school diploma / GED with 12 years of Manufacturing or Operations experience
• Previous managerial experience directly managing people and/or leading teams, projects, programs, or resource allocation

Preferred Qualifications

• Bachelor’s degree in Life Sciences or Engineering
• Strong leadership skills and technical understanding of biotechnology production operations
• Experience in biotechnology or pharmaceutical plant start‑up
• Understanding of downstream purification operations (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
• Experience in a cGMP environment
• 5+ years process experience in a cGMP manufacturing facility
• 3+ years in a production Area Lead, Specialist or Manager role
• Excellent performance management, conflict resolution, analytical problem‑solving, and project management skills
• Thorough understanding of regulatory requirementsExcellent verbal and written technical communication skills
• Proficient with Microsoft, EBR/MES, Delta V, and Electronic quality systems

What You Can Expect Of Us

The annual base salary (U.S.) is provided below. In addition, Amgen offers a Total Rewards Plan, including health and welfare plans, financial planning, work/life balance, and career development opportunities.

• Comprehensive benefits package: Retirement and Savings Plan with substantial company contributions, group medical, dental, vision, life and disability insurance, flexible spending accounts.
• A discretionary annual bonus program.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
• Flexible work models, including remote work arrangements where possible.