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Senior Engineer, Process Development

4 months ago

Holly Springs, Georgia, United States Amgen Full time

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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Engineer, Process Development (Upstream)

Live

What you will do

Let's do this. Let's change the world. In this vital role you will advance Amgen latest bioprocessing platform and technology, delivering high quality of medicine to patients around the world.

The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgen's FleX Batch facility, focusing on technology transfer, process support, and optimization. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

  • Support technology transfer, process validation, and plant start-up
  • Provide technical leadership in Upstream/Harvest Bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management
  • Partner with multi-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
  • Provide on-the-floor process support as required
  • Ensure safety and compliance of process development activities
  • Collaborate with other site-functions and network drug substance teams in delivering plant goals
  • Support regulatory filing, inspection, and other CMC activities

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team-player with these qualifications.

Basic Qualifications:

  • High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR
  • Associate's degree and 8 years of biologics process development or commercial-scale technical support experience OR
  • Bachelor's degree & 4 years of biologics process development or commercial-scale technical support experience OR
  • Master's degree & 2 years of biologics process development or commercial-scale technical support experience OR
  • Doctorate degree

Preferred Qualifications:

  • Bachelor's degree in Engineering or Science field
  • 5+ years of proven experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
  • In-depth expertise in biologics cell culture and/or harvest processes
  • Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
  • Strong oral and verbal communication skills, interact effectively with diverse internal and external partners
  • Able to apply engineering principles and statistical analysis in resolving complex issues
  • Knowledge in regulatory filings and inspections
  • Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes
  • Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use)

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.