Manager Manufacturing Programs – Investigations

Career Category

Manufacturing

Job Description

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.

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.

Manager Manufacturing   Programs   –   Investigations

Live  

What you   will do

Let's   do this.   Let's   change 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 conducts   timely , thorough, and compliant deviation investigations while driving operational excellence,   inspection   readiness, and continuous improvement.

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.

​

Win

What we expect   of   you

The collaborative leader we   seek   has extensive   biologics   drug substance manufacturing experience with   demonstrated   success leading technical teams, driving cross-functional collaboration, and improving quality systems.

Basic Qualifications

Doctorate degree

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

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,   prograns , or directing the allocation   or   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.

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.

. Salary Range

USD - USD