Amgen Inc

Manager Manufacturing Programs - Investigations

Amgen Inc • $100K — $130K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Doctorate degree or Master's with 3 years of experience or Bachelor's with 5 years of experience or Associate's with 10 years of experience or High school diploma with 12 years of experience in relevant field.
  • Experience directly managing teams or projects, with a history of leadership in a technical context.
  • Strong knowledge of biologics manufacturing, microbiology, and quality systems is preferred.
  • Expertise in root cause analysis and investigations within a regulated environment.
  • Familiarity with GMPs, contamination control, and environmental monitoring processes.

Responsibilities

  • Lead and mentor a team of Manufacturing Investigation Specialists to ensure timely and compliant investigations.
  • Apply microbiology principles to enhance environmental monitoring investigations.
  • Create an inclusive atmosphere that encourages open dialogue and diverse perspectives.
  • Manage team workload, resource allocation, and performance metrics effectively.
  • Oversee technical aspects of manufacturing and environmental investigations for quality assurance.
  • Drive consistent root cause analysis and corrective action plans (CAPA) development.
  • Collaborate cross-functionally with various departments to support manufacturing operations.

Benefits

  • Comprehensive health and welfare benefits package.
  • Retirement savings options with company contribution.
  • Annual bonus opportunities and stock-based long-term incentives.
  • Generous paid time off including company shutdowns.
  • Career development opportunities to foster professional growth.
Full Job Description
Career Category
Manufacturing
Job Description

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

About Amgen Inc

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. The company is values-based and deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious diseases. They offer products for treating illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.

Amgen Inc Careers

Join the dynamic team at Amgen Inc, a biotechnology pioneer dedicated to discovering, developing, and delivering innovative human therapeutics. At Amgen, we offer more than just job opportunities; we invite you to be part of a culture of leadership, diversity, and innovation.

Work You’ll Do

At Amgen Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that brings real solutions to patients worldwide. Our commitment to your career growth is evident in our professional development and leadership training programs designed to nurture your potential.

Innovate and Lead

Amgen Inc stands at the forefront of biotech innovation. Our team is constantly pushing the boundaries of science and technology. By joining us, you will contribute to a legacy of medical breakthroughs that improve the lives of millions.

Be Part of a Great Team

Amgen’s inclusive culture and commitment to diversity are integral to our success. We believe in empowering our employees with the skills and networking opportunities they need to thrive. Our team’s collaboration is the key to developing groundbreaking solutions.

Future-Proof Your Career

Amgen Inc offers a variety of career paths, from research and development to marketing and sales, providing near-limitless opportunities for advancement. Whether you are looking for a full-time position, an internship, or a leadership role, Amgen has a place for you. Our robust benefits package supports the well-being of our employees and their families, contributing to a fulfilling work-life balance.

Explore Job Opportunities

Discover the impact you can make with a career at Amgen Inc. We are hiring creative, curious, and motivated individuals ready to face challenges head-on. Explore our open positions that match your skills and interests.

Stay Connected

Join our team and stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await.

Interview and Resume Tips

Prepare for your future with Amgen Inc by utilizing our resources designed to enhance your interview skills and polish your resume. Our hiring process is designed to identify and attract professionals who are driven to make a difference.

Amgen Inc—Where Careers Grow

At Amgen Inc, we are committed to turning innovative science into value for patients. If you are passionate about joining a team that makes a difference, search Amgen jobs today and take the first step towards a fulfilling career.

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Join us at Amgen Inc, where your career can flourish in an environment of innovation, leadership, and growth.
Learn more about Amgen Inc
Size
24,200 employees
Market Cap
$141.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7.2 billion
Founded
1980
5 Year Trend
+2.5%
Revenue
$25.4 billion
NASDAQ
AMGN
* Ladders Estimates

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