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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Associate Manufacturing-Product Lifecycle Management

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions to the multi-facility site (AR5 and AR30) and handling the lifecycle of ARI’s product portfolio.

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

Shift: Monday-Friday Admin day shift

Job Description:

• Create and maintain Electronic Batch Records.
• Drive continuous improvements of MBR System and PLM processes.
• Partner with manufacturing staff to develop and/or revise manufacturing SOPs to support new product introduction.
• Develop and maintain the Bill of Materials for each product manufactured at/ transferred to ARI.
• Support the development of manufacturing sample plans.
• Develop and maintain User Requirements (URS) for manufacturing equipment.
• Assist in developing and delivering training materials to manufacturing staff to support new product introduction, product reintroduction, etc.
• Own and manage change controls, NCs, and CAPAs.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The driven professional we seek is an individual with these qualifications.

Basic Qualifications

Master’s degree Or

Bachelor’s degree and 2 years of Manufacturing and Operations experience Or

Associate’s degree and 6 years of Manufacturing and Operations experience Or

High school diploma / GED and 8 years of Manufacturing and Operations experience

Preferred Qualifications

• Manufacturing experience in both upstream and downstream operations.
• Strong understanding of manufacturing equipment and processes.
• Experience with SAP and MES.
• CFR and Regulatory knowledge, Ability to interpret and apply GMP knowledge.
• Project Management Skills.
• Strong analytical and experimental design skills.
• Excellent verbal and written communication skills.
• Technical leadership experience.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com