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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.

Specialist Manufacturing

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as project manager and technical guide for Final Drug Product New Process Introductions (NPI) and Technology Transfers (TT) into Amgen’s clinical packaging facilities. Responsibilities include:

• Work with various NPI/TT support groups to develop, maintain, and implement the NPI/TT project plan. Specialist will function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and customer concern to various levels of management as appropriate.

• Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks.

• Facilitate the development and optimization of NPI/TT business processes. As applicable, serve as a representative on various global network teams or network-sponsored initiatives to advance the Final Drug Product operational practices and technologies.

• Collaborate with Final Product Technologies, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI/TT.

• Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control results, and specifications). Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies.

• Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations.

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR Master’s degree & 3 years of directly-related OR experience OR

• Bachelor’s degree or & 5 years of directly-related experience OR

• Associate’s degree & 10 years of directly-related experience OR

• High school diploma / GED & 12 years of directly-related experience

Preferred Qualifications:

• Engineering experience with process equipment design, construction, commissioning, and qualification

• Experience with combination product/device design development and manufacturing

• Knowledge and expertise in device design control, design transfer, and combination products manufacturing

• Experience with the development and maintenance of device master records, device history records, and process risk assessments (pFMEA)

• Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.)

• Fundamentally sound project management/organization, technical writing, digital literacy, and communication/presentation skills

• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices

• Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.

• Excellent teammate prepared to work in and adopt a team-based culture that relies on collaboration for effective decision-making

• Experienced in balancing multiple, opposing priorities in a fast-paced environment

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

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, improve your expertise, and increase 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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