Associate Engineer, Process Development - Downstream

Amgen•Holly Springs, NC

11d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Engineer, Process Development What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgen’s FleX Batch Biologics Manufacturing Facility. 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. Additionally, the Process Development Associate will use out-of-the-box thinking to contribute to technology development and will demonstrate the desire to expand and develop expertise in downstream protein purification, thereby further contributing to the integrated group. Apply a fundamental understanding of Downstream (Purification) Bioprocessing to support biologics technology transfer, process validation, and plant start-up Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management Ensure safety and compliance of process development activities Provide process on floor process support as required Provide support for regulatory filing, inspection, and other CMC activities What we expect of you We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications.

Requirements

High school diploma / GED and 6 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR Associates and 4 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR Bachelor’s degree

Nice To Haves

Master’s degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences
Some experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
Understanding of protein purification/separation principles
Understanding of process scale-up, technology transfer, troubleshooting, and complex investigation
Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing

Responsibilities

Apply a fundamental understanding of Downstream (Purification) Bioprocessing to support biologics technology transfer, process validation, and plant start-up
Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
Ensure safety and compliance of process development activities
Provide process on floor process support as required
Provide support for regulatory filing, inspection, and other CMC activities