Engineer, Process Development
Company: Amgen
Location: Holly Springs
Posted on: March 27, 2026
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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, Raleigh , Engineer, Process Development, Science, Research & Development , Holly Springs, North Carolina
