Associate Specialist
CurrentAseptically gowned into modules and used various chromatography methods to purify and formulate cell culture media to final mAb intermediate and payload-conjugated mAb drug substances in modules handling materials ranging from OEB1 to OEB6 complying with GXP standards.Executed process steps using chromatography and filtration skids, HMI/PCS, tanks, and various analytical and engineering equipment.Executed process steps following SOPs for batch mAb intermediate campaigns, fed-batch mAb intermediate campaigns, and OEB4 payload-conjugated mAb campaigns while handling OEB6 free payload.Aseptically gowned into module using PAPR Device to process OEB4 payload-conjugated mAb drug substance and handle OEB6 free payload.Prepared and used small scale manual chromatography columns and large scale hydraulic chromatography columns for process steps using chromatography resin.Conducted CIP, P-Test, and SIP procedures on small and large scale tanks.Reviewed MPR, logbook, and SAP documentation to ensure that they are compliant with GXP standards.Preloaded sample submissions and submitted samples in DLIMS for process use, data, and results.Acted as a kitting leader to optimize out-dated kitting procedure to more efficiently stage modules in preparation for process steps.Analyzed campaign process data through MPRs, DLIMS, and BPD Console and presented findings to managers and team members from various divisions across upstream and downstream.Collaborated with managers and team members from various divisions across upstream and downstream with emphasis on cross-functionality.