Process Development Downstream Bioprocess Engineer

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

BASIC QUALIFICATIONS:

• High school diploma / GED and 8 years of Process Development or Operations experience
• Associate’s degree and 6 years of Process Development or Operations experience
• Bachelor’s degree and 2 years of Process Development or Operations experience
• Master’s degree

PREFERRED QUALIFICATIONS:

• 1-2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
• Possess basic 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
• Excellent written and verbal communication
• Demonstrated ability to work under moderate direction.
• Able to analyze and interpret data
• Be a self-starter with the ability to take on several projects at one time

Let’s do this! Let’s change the world! In this vital role you 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.

• 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.
• Execute technology transfer projects to support Amgen Network initiatives. Provide floor support during clinical and validation runs.