Edward Wando

Senior Manufacturing Associate @KBI Biopharma

Responsible for the execution of production activities for early and late-phase Mammalian Cell Culture programs within a GMP environment. Ensures all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT). Identify possible process and record improvements and communicate this to the appropriate personnel. Utilize and demonstrate their past experiences and knowledge of cell culture fundamentals in cell culture media preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, and aseptic technique; as well as in cell culture analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolarity meters) to teach, troubleshoot and continuously improve the daily operations of Upstream manufacturing. Promote and enforce precise and compliant operations. Escalate any deviations/events, document and escalated to the Management and Quality system according to KBI internal notification processes. Manufacture cell culture products per manufacturing batch records and in compliance with quality standards, company policies and current regulations. Perform aseptic technique. Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. Utilize BMRAM for maintenance activities. Utilize PIVison software to monitor bioreactor and collect trends. Utilize Process Pad to input process output from offline analyzers to record bioreactors process. Ensure all items are issued and accounted for during the execution of a record. Participate and be accountable for room 5S. Provide direction/guidance to Manufacturing Associate I and Manufacturing Associate II Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.