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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.

Process Development Downstream Bioprocess Senior Engineer

Live

What you will do

Let’s do this. Let’s change the world. In this role the Sr. Engineer will be part of a team focused on bioprocess purification process optimization, drug substance manufacturing support and new product introductions. The site operates two multiproduct facilities that manufacture a range of innovative biologic and biosimilar medicines. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility.

Responsibilities include:

• Apply a fundamental understanding of protein purification unit operations to support commercial manufacturing processes:
• Large Scale Column Chromatography
• Tangential flow filtration
• Normal Flow Filtration
• Virus Inactivation and Virus Filtration
• Use comprehensive understanding of chemical engineering principles for the scale up of unit operations from bench to commercial scale.
• Provide technical leadership in solving clinical and commercial drug substance process issues involving equipment, scale, and raw materials. Evaluate process capabilities to develop and implement process and yield improvement opportunities.
• Partner with the Process Development laboratories to design experimentation to support process scale up. Perform technical review of data, and author and review GMP documentation.
• Implement technology transfer projects to support Amgen Network initiatives. Provide floor support during clinical and validation runs.

The Sr. Engineer will be encouraged to keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings. This role provides a phenomenal opportunity for career development in areas of leadership, teamwork, collaboration, communication and to develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems.

What we expect of you

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

Basic Qualifications

Doctorate degree

Or

Master’s degree and 3 years of Engineering or Operations experience

Or

Bachelor’s degree and 5 years of Engineering or Operations experience

Or

Associate’s degree and 10 years of Engineering or Operations experience

Or

High School diploma/GED and 12 years of Engineering or Operations experience

Preferred Qualifications

• 6+ years of experience in drug substance process development, characterization and commercial process support
• Possess advanced understanding of regulatory and cGMP requirements
• Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
• Able to manage project resources and elevate relevant issues to project lead and line management
• Excellent written and verbal communication
• Able to build and maintain impactful, multi-functional partnerships and to lead matrix teams to advance complex projects to completion
• Ability to work under minimal direction
• Be able to multi-task and function in a dynamic environment

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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