Aleke Kuoh

Experience

1. Engineer (Drug Substance Scale-up)

   Amgen

   Oct 2020 — Present · Thousand Oaks, CA, US

   Partake in daily cell culture scale-up operations on single use systems (SUS) and stainless-steel processes of large molecules.• Lead new technological development projects supported by senior management such as a new alternating tangential flow (ATF) controller version (V5).• Support new product introductions (NPI) by performing wastewater assessments and process safety reviews for Environment Health Safety and Sustainability (EHSS).• System owner and lead engineer of new 500L DynaDrive bioreactor loaned from ThermoFisher Scientific as part of identification of an alternate supplier for bioreactors.• Completed eight successful runs on the 500L Dynadrive bioreactor and presented findings at the Amgen Symposium 2022• Completed commissioning and qualification (C&Q) efforts as lead engineer on a newly installed Clean out-of-place (COP) bath and new autoclave. Drafted standard operating procedures (SOP) and provided training on both systems.• Collaborate with cross-functional teams throughout the pilot plant network and clinical GMP sites.• Troubleshoot operation issues found on the manufacturing floor followed by process incidents and root cause analysis.• Lead continuous process improvements such as implementing new actuating tool for probe installations and new label cards for equipment staging.• Authored technical reports and presentations to senior management and collaborating scientists. Communicated results from engineering projects to provide testing outcomes and to receive feedback for subsequent steps.• Completed all trainings for SUS (scale-up, waves, bioreactors) and analytical equipment.• Train new team members on SUS operations.• Completing training on stainless steel equipment and operations.• Mentor to four Amgen employees as part of Amgen\'s Mentorship program.