Amgen Inc

Manager Manufacturing Programs - Process Owner Team

Amgen Inc • $100K — $130K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Doctorate degree or equivalent experience in biotechnology or pharmaceutical manufacturing.
  • 3 years of experience in biotechnology or pharmaceutical manufacturing with a Master's degree, or 5 years with a Bachelor's degree.
  • 10 years of relevant experience with an Associate's degree, or 12 years with a high school diploma/GED.
  • Experience managing people and teams, with concurrent technical experience in manufacturing.
  • Strong expertise in either Upstream & Services or Downstream manufacturing operations.

Responsibilities

  • Lead and develop a team of Process Owners in the manufacturing operations.
  • Foster a culture of safety, quality, compliance, and continuous improvement within the team.
  • Oversee technical process stewardship and ensure effective operational readiness activities.
  • Provide floor support and troubleshooting assistance to enhance manufacturing execution.
  • Manage change control activities that impact manufacturing operations.

Benefits

  • Comprehensive benefits package to support professional and personal growth.
  • Career development opportunities within a collaborative culture.
Full Job Description
Career Category
Manufacturing
Job Description

Manager Manufacturing Programs - Process Owner Team

Live

What You Will Do

In this vital role, you will lead a team of Process Owners within the Manufacturing Support organization at Amgen North Carolina (ANC). This position may lead either an Upstream & Services-focused team or a Downstream-focused team and requires strong technical expertise in the applicable manufacturing area combined with demonstrated people leadership capabilities.

The Process Owner Team serves as a critical technical interface between Manufacturing Operations and support organizations, ensuring manufacturing processes are effectively translated into operational execution, manufacturing procedures, and digital manufacturing workflows. The team provides technical process stewardship, manufacturing floor support, operational readiness, CAPA implementation support, manufacturing change management, and procedural governance to enable safe, compliant, and reliable manufacturing operations.

  • Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations.


  • Foster a culture of safety, quality, compliance, accountability, collaboration, and continuous improvement.


  • Provide leadership for technical process stewardship, manufacturing support, operational readiness, and process governance activities.


  • Ensure Process Owners provide effective floor support, hypercare, troubleshooting assistance, and manufacturing execution support.


  • Oversee operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support.


  • Drive accountability for execution and timely closure of Process Owner commitments associated with CAPAs, risk assessments, investigation support activities, change controls, and operational readiness activities.


  • Lead manufacturing-related change control implementation activities impacting manufacturing operations (excluding NPI-related change controls).


  • Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.


  • Partner with Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, and Digital Manufacturing to support facility fit assessments, process overviews, process implementation, and continuous improvement initiatives.


  • Support BOM readiness activities and alignment of single-use assemblies, consumables, and process materials with manufacturing requirements.


  • Ensure appropriate escalation and communication of manufacturing, quality, compliance, and operational risks.


  • Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections.


Win

What We Expect of You

Basic Qualifications

  • Doctorate degree OR


  • Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR


  • Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR


  • Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR


  • High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing 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

  • 7+ years of biotechnology or pharmaceutical manufacturing experience with progressively increasing responsibility.


  • Demonstrated people leadership experience managing, coaching, and developing technical teams.


  • Strong technical expertise in either Upstream & Services manufacturing operations or Downstream manufacturing operations.


  • Experience with GMP manufacturing operations, process stewardship, and manufacturing support.


  • Experience supporting operational readiness activities, including water runs, dry runs, equipment testing, and startup support.


  • Experience with CAPA implementation, CAPA applicability assessments, effectiveness checks, risk assessments, and root cause analysis support.


  • Knowledge of drug substance manufacturing equipment, process flows, and manufacturing operations.


  • Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment.


  • Knowledge of single-use technologies and Bill of Material (BOM) structures.


  • Experience partnering with Process Development on facility fit assessments, process implementation, and knowledge transfer activities.


  • Strong communication, organizational, and cross-functional leadership skills.


Thrive

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being through comprehensive benefits, career development opportunities, and a collaborative culture.

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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