Manager Manufacturing Programs – Investigations

Amgen•Holly Springs, NC

10d•Onsite

About The Position

Amgen is seeking a Manager Manufacturing Programs – Investigations to lead the Manufacturing Investigations team supporting the Amgen North Carolina Biologics Drug Substance Manufacturing plant. This role is crucial for developing a high-performing team that conducts timely, thorough, and compliant deviation investigations while driving operational excellence, inspection readiness, and continuous improvement. The position is within Amgen's newest and most advanced drug substance manufacturing plant, the Amgen FleX batch facility, which combines cutting-edge technologies with sustainability innovations.

Requirements

Doctorate degree OR Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma/GED and 12 years of directly related experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
Managerial experience may run concurrently with the required technical experience.

Nice To Haves

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.

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.