Engineer, Process Development

Company: Amgen
Location: Holly Springs
Posted on: March 27, 2026

Job Description:

HOWMIGHT YOU DEFY IMAGINATION? Youveworked 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,experienceand 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 over10 million patientsworldwide. Come do your bestworkalongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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. Engineer, Process Development Live What youwill do In this role you willbe a part ofthe Process Development Drug Substance Technology group at AmgensFleXBatch BiologicsManufacturing 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. Apply a fundamental understanding of Downstreambioprocessing to supportbiologicstechnology transfer,process validation, and plant start-up Supportcontinuous process verification,processmonitoring,optimization,complex investigation, and product life cycle management Ensure safety and compliance of process development activities Provide process on floorprocesssupportasrequired Provide support for regulatory filing, inspection, andotherCMC activities Responsibilities: Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (downstream purification)in the development of process improvements, facility adaptations, and new process operations. Provide technical and on-the-floor support toassistin the troubleshooting of clinical and commercial drug substance manufacturing. Support the GMP manufacturing processevaluations and investigations. Develop novel mammalian next generationtechnologiesto increase yield,process robustness, and enable new unit operations. Basic Qualifications: High school diploma / GED and 8 yearsof process science or technology transfer experience Associates degree and 6 years of process science or technology transfer experience Bachelors degree and 4 years of process science or technology transfer experience Masters degree Preferred Qualifications: 2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing. Chromatography,ultrafiltrationand normal flow filtration operations experience Chemical engineering principles for the scale up of unit operations from bench scale to commercial scale. 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 Experience developing and managing team training workflows and strategy. Demonstrated ability to workundermoderate direction. Able to analyze and interpret data Be a self-starter with the ability to take on several projects at one time. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing,manufacturingand delivering innovativehuman therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need andleveragesitsexpertiseto strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Keywords: Amgen, Burlington , Engineer, Process Development, Science, Research & Development , Holly Springs, North Carolina