Engineer, Process Development

Engineer, Process Development What you will do In this role you will be a part of the Process Development Drug Substance Technology group at Amgen’s FleXBatch 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. Apply a fundamental understanding of downstream bioprocessing to support biologic technology transfer, process validation, and plant startup Support continuous process verification, monitoring, optimization, complex investigation, and product life cycle management Ensure safety and compliance of process development activities Provide process on‑floor support as required Provide support for regulatory filing, inspection, and other CMC 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‑floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing. Support the GMP manufacturing process evaluations and investigations. Develop novel mammalian next‑generation technologies to increase yield, process robustness, and enable new unit operations. Basic Qualifications High school diploma / GED and 8 years of process science or technology transfer experience Associate’s degree and 6 years of process science or technology transfer experience Bachelor’s degree and 4 years of process science or technology transfer experience Master’s degree Preferred Qualifications 2 years of experience in a biotech/pharma process development and/or manufacturing support role for drug substance manufacturing Chromatography, ultrafiltration and normal flow filtration operations experience Chemical engineering principles for the scale‑up of unit operations from bench scale to commercial scale Ability to apply engineering principles and statistical analysis, including design of experiments, 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 work under moderate direction Ability to analyze and interpret data Self‑starter with the ability to take on several projects at one time #J-18808-Ljbffr