Manufacturing Specialist - Downstream Mfg Support (Process Owner)

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist Manufacturing - Downstream Mfg Support (Process Owner)

What you will do

Let’s do this. Let’s change the world! In this vital role, you will support the execution of manufacturing and quality systems, including procedures, deviations, process validation, training, and new product introductions. You will apply process, operational, and scientific expertise, along with compliance knowledge, analytical skills, and troubleshooting abilities, to ensure smooth manufacturing operations.

As a key contributor in the Downstream manufacturing area, you may serve as a primary process owner for new product development and major process changes, driving operational excellence.

Specific responsibilities include but are not limited to:

• Initiate, revise, and approve manufacturing-controlled documents in the document management system. Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards.
• Implement new product introductions and major projects within Drug Substance (DS) operations. Collaborate with Capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training, and floor readiness.
• Analyze floor operations data and observations to identify root causes of deviations or inefficiencies. Develop and implement data-driven solutions to drive process improvements and enhance operational performance.
• Ensure timely investigation and resolution of deviations within established goals. Perform deviation assessments, support root cause analysis (RCA), human performance evaluations, and CAPA development. Monitor CAPA effectiveness to prevent recurrence and take additional corrective actions as needed.
• Assist in the development and execution of process validation protocols and reports. Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
• Support the establishment of process monitoring parameters and control limits, ensuring timely execution of process performance or validation reports and deviation assessments.
• Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
• Support monitoring initiatives by configuring applicable requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire). Ensure configurations align with process design, GMP requirements, and Amgen guidelines. Work closely with process owners, process development, and automation teams to design and implement new processes or modifications.
• Use Application Life Cycle Management (ALM) system during validations and navigate SAP for master data, process orders, production versions, inventory, and bill of materials (BOMs). Ensure SAP-MES PAS/X connectivity, troubleshoot IDoc communication issues, and maintain alignment between SAP and MES configurations, particularly for BOM accuracy and process integration.
• Assess, prioritize, justify, and support implementation of process or equipment modifications, providing project management support. Participate in the assessment and execution of special projects or initiatives to enhance manufacturing operations.
  

What we expect of you

We are all different! Yet, we all use our unique contributions to serve patients. The Specialist Manufacturing professional we seek is an Individual Contributor with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 2 years of Manufacturing support experience

OR

Bachelor’s degree and 4 years of Manufacturing support experience

OR

Associate’s degree and 8 years of Manufacturing support experience

Or

High school diploma / GED and 10 years of Manufacturing support experience

Preferred Qualifications:

• Educational background in Life Sciences and/or Engineering.
• In-depth experience of Downstream manufacturing processes.
• Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)
• Familiar with Lean Manufacturing Practices
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Proficiency in GDP (Good Documentation Practices) on a regulated environment
• Knowledge in systems: EBR, Trackwise, Spotfire, CDOCS, and process monitoring platforms
• Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
  

What you can expect of us

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.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and an annual site shutdown
• Flexible work models, including remote work arrangements, where possible
  

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.