Senior Manager, Manufacturing Investigations & Programs

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health and welfare benefits

Annual bonus opportunity

Stock-based long-term incentives

Generous paid time off

Job summary

Amgen is seeking a Manager Manufacturing Programs Investigations in the United States. You will lead a team of Manufacturing Investigation Specialists, applying advanced microbiology and environmental monitoring principles to support investigations.

You will build a safe, inclusive culture while driving root-cause analysis and CAPA across functions. You will collaborate with Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development, oversee governance for deviations, and

Qualifications

• Doctorate or Master’s with related experience or equivalent
• Bachelor’s with 5+ years of related experience; Associate’s with 10+ years; High school with 12+ years
• Experience directly managing people or leadership of teams/projects/prograns, or resource allocation

Responsibilities

• Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists
• Apply microbiology and environmental monitoring knowledge to support investigations
• Create an environment of psychological safety and encourage diverse perspectives
• Manage team priorities, workload, and performance
• Provide technical oversight of manufacturing and environmental monitoring investigations
• Drive root-cause analysis and CAPA development
• Serve as site subject matter expert for Environmental Monitoring investigations
• Lead cross-functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development
• Lead escalation and governance for deviations
• Support regulatory inspections and internal audits
• Monitor investigation metrics and drive continuous improvement
• Champion Operational Learning Team principles
• Develop investigation procedures, standards, and training
• Build a culture of accountability, inclusion, and operational excellence

Skills

People leadership

Cross-functional collaboration

GMP knowledge

Environmental monitoring

Root cause analysis

Problem solving

Coaching

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

Tools

Veeva QMS

Job description

Amgen is seeking a Manager Manufacturing Programs Investigations in the United States. You will lead a team of Manufacturing Investigation Specialists, applying advanced microbiology and environmental monitoring principles to support investigations.

You will build a safe, inclusive culture while driving root-cause analysis and CAPA across functions. You will collaborate with Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development, oversee governance for deviations, and