Engineer I Upstream Drug Substance Technologies and Engineering

Amgen•Thousand Oaks, CA

11h•$88,281 - $119,439

About The Position

Amgen is seeking an Engineer to join the Drug Substance Technology Engineering team supporting Amgen Thousand Oaks (ATO) Drug Substance Manufacturing facilities. The role supports technology transfer and process validation for human therapeutic biological drug substance products across clinical and commercial manufacturing. The position also contributes to process improvements, manufacturing support, troubleshooting, process analysis, and operational excellence, collaborating with Manufacturing, Quality, Regulatory, and other functions.

Requirements

Master’s degree; or Bachelor’s degree and 2 years of Process Development experience; or Associate’s degree and 6 years of Process Development experience; or high school diploma/GED and 8 years of Process Development experience.
Strong capability in scientific, engineering, and laboratory analysis, troubleshooting, and applying sophisticated problem-resolution abilities.
Ability to develop and follow detailed protocols.
Motivation to work independently, multitask, and work in teams.
Excellent written and verbal communication skills, including experience with technical writing and presentations.

Nice To Haves

Master’s degree in Chemical/Biochemical Engineering or a related subject area.
3 or more years of Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and biologics manufacturing under cGMP.
Upstream process knowledge and hands-on cell culture and/or purification pilot, clinical, or commercial experience manufacturing biological drug substance.
Experience working in or supporting a commercial cGMP manufacturing facility.
Understanding of cell culture processes and related equipment; scale-up from bench to commercial scale; mass oxygen transfer capabilities; metabolism profiling; raw material attribute influences; and the impact of process deviations on growth and quality attributes.
Knowledge of aseptic processing and techniques, and mammalian cell culture harvest and clarification processes, and/or understanding of purification processes and associated equipment, including chromatography, ultrafiltration, normal flow filtration, virus inactivation, and virus filtration.
Process development experience supporting large-scale cGMP manufacturing.

Responsibilities

Transfer cell culture drug substance processes and perform process improvements from the laboratory into manufacturing facilities and between manufacturing sites.
Provide process validation support for late-stage commercial processes.
Provide on-the-floor technical support for scale-up and technology transfer, and for clinical or commercial manufacturing operations.
Perform routine process monitoring and troubleshooting.
Trend data and conduct statistical process analysis.
Provide technical contributions to process-related deviations (NCs), CAPAs, and change controls.
Identify and support process-related operational excellence opportunities.
Represent process development and collaborate with functions including Manufacturing, Quality, and Regulatory.