Senior Manager, Cleaning Validation Programs

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 136,000 - 184,000; Full time

Benefits offered by this job

Comprehensive benefits

Retirement plan

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Flexible spending accounts

Bonus program

Stock-based incentives

Paid time off

Flexible work models

Job summary

Amgen NC site seeks a Manufacturing Programs Senior Manager focused on cleaning validation for Biologics Drug Substance plants. You will lead cross-plant teams, ensuring regulatory compliance and delivering on-time validation deliverables.

You will drive improvement initiatives, support CAPA, and develop standard work for validation, while coordinating training and inspection readiness across the network.

Qualifications

• Biologics DS manufacturing background required with leadership exp.
• Experience managing teams, projects, or resources.
• GMP manufacturing operations knowledge preferred.

Responsibilities

• Lead cleaning validation teams across multiple facilities.
• Ensure regulatory compliance of cleaning validation program.
• Drive continuous improvement and productivity gains.
• Develop inspection readiness tools and training.
• Champion Lean Transformation and operational excellence.

Skills

Biologics DS manufacturing

Cross-functional collaboration

Project leadership

Problem solving

Lean transformation

Education

Doctorate in chemistry/biology/engineering

Master in chemistry/biology/engineering

Bachelor's in biotechnology

2+ years people leadership

Job description

Amgen NC site seeks a Manufacturing Programs Senior Manager focused on cleaning validation for Biologics Drug Substance plants. You will lead cross-plant teams, ensuring regulatory compliance and delivering on-time validation deliverables.

You will drive improvement initiatives, support CAPA, and develop standard work for validation, while coordinating training and inspection readiness across the network.