Manager Manufacturing Programs – Investigations

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

Job summary

Amgen in Holly Springs, NC, is seeking a senior Manufacturing Investigation Specialist to lead a team focused on deviation and environmental monitoring investigations, leveraging microbiology expertise to ensure quality and compliance in a state‑of‑the‑art facility.

The role emphasizes coaching, accountability, and continuous improvement within a high‑growth biopharma environment, with opportunities for impact across Manufacturing, Quality, Engineering, and Process Development.

Qualifications

• Doctorate degree required.
• Master’s degree with 3+ years related experience.
• Bachelor’s degree with 5+ years related experience.
• Associate’s degree with 10 years related experience.
• High school diploma/GED with 12 years related experience.
• Experience directly managing people or leadership role.

Responsibilities

• Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists specializing in simple deviation and environmental monitoring investigations.
• Apply advanced understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
• Create an environment of trust and psychological safety where team members feel empowered to raise concerns, challenge assumptions, share diverse perspectives, and contribute openly to problem‑solving discussions.
• Manage team priorities, workload balancing, resource planning, and performance management.
• Provide technical oversight of manufacturing and environmental monitoring investigations.
• Drive consistency in root cause analysis and CAPA development.
• Serve as site subject‑matter expert for Environmental Monitoring‑related investigations.
• Lead cross‑functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development.
• Lead escalation and governance for deviations.
• Support and present during regulatory inspections and internal audits.
• Monitor investigation metrics and drive continuous improvement.
• Champion Operational Learning Team principles and organizational learning.
• Develop investigation procedures, standards, and training.
• Build a culture of accountability, inclusion, and operational excellence.

Skills

People leadership

Team management

Environmental monitoring

Root cause analysis

CAPA development

GMP knowledge

Microbiology

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

Veeva QMS

Job description

Overview

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever‑better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Facility

Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single‑use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon‑neutral company by 2027.

Responsibilities

• Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists specializing in simple deviation and environmental monitoring investigations.
• Apply advanced understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
• Create an environment of trust and psychological safety where team members feel empowered to raise concerns, challenge assumptions, share diverse perspectives, and contribute openly to problem‑solving discussions.
• Manage team priorities, workload balancing, resource planning, and performance management.
• Provide technical oversight of manufacturing and environmental monitoring investigations.
• Drive consistency in root cause analysis and CAPA development.
• Serve as site subject‑matter expert for Environmental Monitoring‑related investigations.
• Lead cross‑functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development.
• Lead escalation and governance for deviations.
• Support and present during regulatory inspections and internal audits.
• Monitor investigation metrics and drive continuous improvement.
• Champion Operational Learning Team principles and organizational learning.
• Develop investigation procedures, standards, and training.
• Build a culture of accountability, inclusion, and operational excellence.

Qualifications

• Doctorate degree
• Master’s degree and 3 years of directly related experience
• Bachelor’s degree and 5 years of directly related experience
• Associate’s degree and 10 years of directly related experience
• High school diploma/GED and 12 years of directly related experience
• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications

• 5+ years of biologics manufacturing, microbiology, quality, or related pharmaceutical experience.
• 0-2 years of people leadership or technical leadership.
• Strong knowledge of GMPs, contamination control, and environmental monitoring.
• Expertise leading investigations and root cause analysis.
• Degree in Science or Engineering (Microbiology or similar a plus).
• Experience with Veeva QMS or equivalent quality systems.
• Experience supporting FDA and global regulatory inspections.
• Strong communication, coaching, and organizational leadership skills.

Salary & Benefits

The annual salary range for this opportunity in the U.S. is [HR to input market pay range]. In addition to base salary, Amgen offers a comprehensive Total Rewards package including health and welfare benefits, retirement savings, annual bonus opportunity, stock‑based long‑term incentives, generous paid time off, company shutdowns, and career development opportunities.