Manager ManufacturingProgramsInvestigations

BioSpace; Holly Springs (NC); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Annual bonus

Stock-based incentives

Generous PTO

Job summary

Amgen's North Carolina Biologics Drug Substance Manufacturing plant is seeking a senior leader to head the Manufacturing Investigations team. You will develop a high-performing group that conducts timely, thorough, and compliant deviation investigations while driving operational excellence and inspection readiness.

The role requires extensive biologics manufacturing experience, strong leadership, and proven ability to collaborate across Manufacturing, Quality, Engineering, Automation, EHSS, and

Qualifications

• Advanced biologics manufacturing experience with proven leadership of technical teams.
• Experience driving cross-functional collaboration and quality systems improvements.
• Familiarity with environmental monitoring programs and contamination control strategies.
• Experience supporting FDA and global regulatory inspections.

Responsibilities

• Lead, develop, coach, and mentor the Manufacturing Investigation Specialists team.
• Provide technical oversight of manufacturing and environmental monitoring investigations.
• Drive root cause analysis, CAPA development, and cross-functional escalation governance.
• Support regulatory inspections and internal audits; monitor investigation metrics for continuous improvement.

Skills

Biologics manufacturing

Leadership

Cross-functional collaboration

Environmental monitoring

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Tools

Veeva QMS

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, anddeliveringever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch 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.

Manager Manufacturing

Programs

Investigations

Live

What Youwill Do

Let'sdo this.Let'schange the world.In this vital leadership role, you will lead the Manufacturing Investigations team supporting the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will develop a high-performing team that conductstimely, thorough, and compliant deviation investigations while driving operational excellence,inspectionreadiness, and continuous improvement.

• Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialistsspecializing in simple deviation and environmentalmonitoringinvestigations.


• Applyadvancedunderstanding 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 oversightofmanufacturing and environmental monitoring investigations.


• Drive consistency in root cause analysis and CAPA development.


• Serve as site subject matter expert forEnvironmental Monitoringrelatedinvestigations.


• Lead cross-functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development.


• Lead escalation and governance fordeviations.


• Supportand present duringregulatory inspections and internal audits.


• Monitorinvestigationmetrics 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.
  

Win

What We Expectofyou

The collaborative leader weseekhas extensivebiologicsdrug substance manufacturing experience withdemonstratedsuccess leading technical teams, driving cross-functional collaboration, and improving quality systems.

Basic Qualifications

• Doctorate degree


• Master'sdegreeand3years ofdirectly relatedexperience


• ORBachelor'sdegree and 5 years ofdirectly relatedexperience


• ORAssociate'sdegree and 10 years ofdirectly relatedexperience


• OR High school diploma/GED and 12 years ofdirectly relatedexperience


• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leadingteams, projects,prograns, or directing the allocationorresources.Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• 5+ years ofbiologicsmanufacturing, microbiology, quality, or related pharmaceutical experience.


• 0-2years ofpeopleleadership or technical leadership.


• Strong knowledge of GMPs, contamination control, and environmental monitoring.


• Expertiseleading investigations and root cause analysis.


• Degree in Science or Engineering(Microbiology or similara plus).


• Experience with Veeva QMS or equivalent quality systems.


• Experience supporting FDA and global regulatory inspections.


• Strong communication, coaching, and organizational leadership skills.
  

Thrive

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.