Process Development Engineer
CurrentReagent Manufacturing Led Process Development activities with the Reagent Manufacturing group for an NGS assay run in a CLIA lab, including Reagent Scale-up, Process Transfer for Automated aliquoting of key NGS reagents (UDI). Served as SME and troubleshooting expert for Production and QC activities. Oversaw end to end Change proposals to simplify QC testing and reduce operational costs. ( AlloSure product line) Managing project to replace aging Liquid Handlers and manual plate sealing processes with an automated LHI-Sealer-Stacker system (Tecan 1080).Scale-up solutions to optimize yield, cycle time and batch size to minimize costly QC events.Process EngineeringSupport for CLIA Lab Operations, Reagent Manufacturing, Facilities, Automation and Supply Chain teams. (Process Mapping, Documentation for QMS, Space Planning, Facilities Validation, Equipment/ Process Re-qualification, Root Cause Analysis)V&V activities for Process and Equipment Relocations. Validated an automated Plate Labeler system (Squix) and implemented into Production. (Mfg.) Planned and executed a phased Lab relocation without any impact to a 24*6 CLIA Lab Operations environment. (Space Planning, Move Logistics, Equipment, Process and Facilities V&V). Capacity Planning to add additional instruments (LHI’s, Thermocyclers, Sequencers) to the existing fleet and get them qualified to ensure no impact to Lab operations during the Lab relocation. Executed a phased move of aging Liquid Handlers (Biomek Fx/ FxP 3000, currently phased out of the market) for the Manufacturing lab and re-qualified all equipment without any disruption to production. Minimizing Scrap Exposure and providing expiry date extension for key reagents through statistical analysis and/or accelerated stability testing protocols of key reagents