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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Principal Engineer – Manufacturing Technology Advancement, Process Development

Live

What you will do

Let’s do this. Let’s change the world. The Principal Engineer is based in Thousand Oaks on our Manufacturing Technology Advancement team within Process Development. This group’s mission is to identify, design, develop, and implement novel manufacturing technologies into Amgen’s worldwide multimodality clinical and commercial manufacturing network. The Principal Engineer will lead our team of scientists and engineer passionate about on technology advancement in the parenteral drug product and final product processes. This role is essential for the success of Amgen Operations in its goal to ensure supply to our patients while driving a culture of continuous improvement, innovation, and transformation.

A successful candidate will be able to operate independent of executive oversight, taking ownership for team projects and managing, prioritizing, and resourcing team work packages with appropriate communication. They will thrive in a multi-functional team environment, adeptly collaborating and liaising with partner organizations across Operations (Process Development, Manufacturing, Engineering, Quality) as well as in Information Systems, Legal, Business Development, and Research and Development.

They will foster a creative, collaborative, safe, diverse team culture, enabling themselves and their team to pinpoint and conceive novel techniques and approaches to solve relevant problems. They will be comfortable with uncertainty, maintaining near term team progress despite ambiguity and instituting business processes to improve long-term team and partner organization performance. They will thus deliver value-adding and differentiating solutions to Amgen Process Development.

Specific responsibilities of the technology advancement team lead will include, but are not limited to:

• Driving the operationalization of new technologies into our CGMP manufacturing processes through handoff to Manufacturing and Engineering staff and under Quality oversight;
• Applying scientific, engineering, and technical principles (e.g., data science, robotics, programming, artificial intelligence, machine vision, etc.) to advance innovative process, automation, and analytics technologies;
• Staying abreast of industry trends on modern manufacturing technologies, especially in the realms of process automation and artificial intelligence, and critically assessing external vendor proposals based on sound technical judgment and robust understanding of internal business needs;
• Participating in and leading multi-functional teams to drive continuous improvements in the Process Development organization as well as across the worldwide Amgen manufacturing network;
• Supporting the team in designing, prototyping, and evaluating novel technologies in laboratory and pilot plant environments, following good laboratory practices, strictly adhering to safety and environmental standards, and proactively anticipating Quality and regulatory agency questions;
• Guiding the team in generating, analyzing, documenting, and presenting data packages related to new manufacturing and analytical technology development, with an emphasis on critically assessing the benefits and drawbacks of candidate technologies;
• Ensuring knowledge management via cross-functional knowledge sharing, intellectual property capture, and technical documentation per good documentation practices; and
• As needed, traveling domestically and internationally up to 10% of the time.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The process development professional we seek will possess these qualifications.

Basic qualifications:

• Doctoral degree & 2 years Process Development experience

Or

• Master’s degree & 6 years Process Development experience

Or

• Bachelor’s degree & 8 years Process Development experience

Or

• Associate’s degree & 10 years Process Development experience

Or

• High school diploma or GED certification & 12 years Process Development experience

Preferred qualifications:

• Advanced degree in engineering, physics, material science, pharmaceutical sciences, biotechnology, or related field;
• 2+ years of experience in the pharmaceutical or biotechnology industry, or highly relevant academic experience;
• Ability to direct a team of high professional engineers and scientists with niche skills;
• Comfort with data science principles, coding, process automation, statistical techniques, deep learning, machine learning, artificial intelligence, robotics, machine vision, and additive manufacturing;
• Familiarity with biologics fill-finish, inspection, assembly, labeling, and packaging manufacturing processes;
• Strong written and verbal communication skills, as well as the ability to regularly and successfully interact with colleagues from diverse backgrounds and with a range of technical proficiencies;
• The ability to learn and act upon dynamic information at a rapid pace in a multi-functional environment;
• Proficiency in technical problem solving, critical thinking, and the delivery of value-adding solutions with limited executive oversight and technical direction.

Thrive

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.

• Vast opportunities to learn and move up and across our global organization
• 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com