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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-NPI/EBR

New Product Introduction/Electronic Batch Record (NPI/EBR) Senior Associate

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be a part of the Amgen, Thousand Oaks, Drug Substance Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics and for communication between the GMP operations teams and the process development scientific groups. This Senior Associate position will be focused on downstream drug substance operations.

Job scope and responsibilities:

• Manufacturing support focused on Electronic Batch Record (EBR) generation, editing, real-time troubleshooting and managing the EBR validation for new or modified processes.
• Assisting in the implementation of new MES functionality.
• Generation of paper process documents when required.
• Leading resupply process execution efforts including coordinating with Supply Chain, Planning, Facilities and Automation Engineering as well as Manufacturing to ensure that production documents (paper and electronic) are accurate and up to date.
• Contributing to Lean Transformation through recording NPI metrics and application of continuous improvement tools.
• Participate and contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Master’s degree Or

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

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

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

Preferred Qualifications:

• Significant experience with purification drug substance operations in a GMP regulated environment
• Significant experience with PAS X, Werum software for electronic batch records with some understanding of editing and validation
• Degree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology
• Demonstrated technical writing skills
• Strong operations knowledge of purification and a broad understanding of related disciplinary areas in bioprocessing
• Demonstrated ability to work in a team

Thrive

Some of the vast rewards of working here

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.

• 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.

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