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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.

New Product Introduction (NPI) Senior Associate Manufacturing

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you join the New Product Introduction (NPI) Team for B20 GMP Drug Product Supply. This position is within the Amgen Thousand Oaks (ATO) Manufacturing and Clinical Supply - Manufacturing Systems organization.

ATO B20 is a dynamic environment and an important launch point for Amgen’s pipeline products. The GMP DPS plant manufactures drug product for clinical trials through commercial production using single-use equipment platforms. This role is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Product Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality. The New Product Introduction senior associate will

• Coordinate with PD, DPTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing to introduce new products into the plant.

• Lead or participate in projects, ensuring that production documents are accurate and up to date.

• Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.

• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and supervises progress on a plant level.

• Collaborate with Regulatory and Quality partners to lead change control records and respond to regulatory questions and/or audit findings.

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 an individual with these qualifications.

Basic Qualifications:

• Master’s degree OR

• Bachelor’s degree and 2 years of biotechnology operations experience OR

• Associate’s degree and 6 years of biotechnology operations experience OR

• High school diploma / GED and 8 years of biotechnology operations experience

Preferred Qualifications:

• Excellent technical writing skills and experience with electronic documentation systems

• Experience with PAS X, Werum software

• Experience in GMP operations

• Strong technical knowledge of drug product processing and a broad understanding of related disciplinary areas in bioprocessing

• Ability to effectively communicate technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

• Background in lean manufacturing methodologies and operational excellence

• Experience in cross functional Project Management

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.

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