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Senior Engineer, Process Development (Downstream)

Employer
Amgen
Location
Holly Springs, North Carolina
Start date
Jun 17, 2024

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 (Downstream)

Live!

What you will do

Lets do this. Lets 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 Amgens 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 Downstream (Purification) 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
  • Associates degree and 8 years of biologics process development or commercial-scale technical support experience OR
  • Bachelors degree & 4 years of biologics process development or commercial-scale technical support experience OR
  • Masters degree & 2 years of biologics process development or commercial-scale technical support experience OR
  • Doctorate degree

Preferred Qualifications:

  • Bachelors degree in Engineering or Science field
  • 5+ years proven experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
  • In-depth expertise in biologics process purification processes
  • Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
  • Strong oral and verbal communication skills, interact optimally with diverse internal and external collaborators
  • 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.

careers.amgen.com

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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