Amgen Inc

Specialist Manufacturing - Process Owner - Upstream / Downstream / Services

Amgen Inc • $107K — $145K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Doctorate with 2 years or Master's with 4 years in biotech operations.
  • Bachelor's with 6 years or Associate's with 10 years in biotech operations.
  • High school diploma with 12 years of biotech operations experience.
  • Technical expertise in Upstream/Downstream manufacturing or manufacturing services.
  • Strong knowledge of GMP processes and equipment.

Responsibilities

  • Serve as the technical process owner for assigned manufacturing processes.
  • Provide troubleshooting assistance on the manufacturing floor.
  • Support operational readiness activities like equipment testing and EBR support.
  • Partner with Manufacturing Operations for compliant, efficient manufacturing execution.
  • Monitor and optimize process performance for operational improvement.
  • Author and maintain GMP documentation including SOPs.
  • Participate in root cause analysis and support manufacturing investigations.

Benefits

  • Comprehensive benefits package for professional and personal well-being.
  • Career development opportunities in a collaborative culture.
Full Job Description
Career Category
Manufacturing
Job Description

Specialist Manufacturing - Process Owner - Upstream / Downstream / Services (Multiple Positions)

Live

What You Will Do

In this vital role, you will serve as a Process Owner within the Manufacturing Support organization at Amgen North Carolina (ANC). The Process Owner serves as a technical process steward and key interface between Manufacturing Operations and support organizations. This role is responsible for supporting manufacturing execution through technical process ownership, floor support, operational readiness activities, process governance, manufacturing change implementation support, and continuous improvement initiatives.

This position may support one of the following manufacturing areas depending on business needs and organizational assignment: Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

  • Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.


  • Provide manufacturing floor support, troubleshooting assistance, and hypercare during routine manufacturing operations, process changes, startup activities, and first-time executions.


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


  • Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.


  • Monitor process performance and identify opportunities for process optimization, operational improvement, and risk reduction.


  • Support manufacturing-related change controls associated with process, equipment, procedural, and operational improvements.


  • Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.


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


  • Provide technical input to manufacturing risk assessments and support identification and mitigation of process, equipment, procedural, and operational risks.


  • Participate in root cause analysis (RCA) activities and provide technical process expertise to support manufacturing investigations, major deviations, and quality events.


  • Support CAPA applicability assessments, CAPA implementation activities, and CAPA effectiveness checks.


  • Partner with Process Development to support process overviews, knowledge transfer activities, and facility fit assessments.


  • Partner with Supply Chain, Manufacturing, and Engineering to support material readiness and Bill of Material (BOM) alignment, including single-use assemblies and consumables.


  • Support MES and EBR activities by providing process expertise and manufacturing representation.


  • Participate in inspection readiness activities and support audits as required.


  • Appropriately escalate process, operational, quality, and compliance concerns.


Win

What We Expect of You

Basic Qualifications

  • Doctorate degree and 2 years of biotechnology operations experience OR


  • Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field and 4 years of biotechnology operations experience OR


  • Bachelor's degree and 6 years of biotechnology operations experience OR


  • Associate's degree and 10 years of biotechnology operations experience OR


  • High school diploma / GED and 12 years of biotechnology operations experience


Preferred Qualifications

  • Technical expertise in Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).


  • Strong technical knowledge of drug substance manufacturing processes, equipment, and unit operations.


  • Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.


  • Experience supporting manufacturing floor operations, troubleshooting, and hypercare activities.


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


  • Experience authoring and maintaining GMP documentation including SOPs and manufacturing procedures.


  • Experience supporting manufacturing change controls and implementation activities.


  • Experience participating in risk assessments, root cause analyses, investigations, and CAPA implementation activities.


  • Experience supporting CAPA applicability assessments and effectiveness checks.


  • 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.


  • Strong technical writing, communication, problem-solving, and organizational 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
107,545.40USD -145,502.60 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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