Participated in the Purification operations of more than 5 different cell lines, Including the successful completion of Lilly’s groundbreaking Alzheimer’s drug.Completed Training enabling me to complete deviation investigations, develop CAPA’s and change controls.Completed the commissioning and start up of the new suite, which included IQ, OQ, and PQ’s.Creating schedules for daily operations encompassing all of production.Lead teams of operators to complete validation protocols of the new 1.4m columns, ProtienA and IEX chromatography skids efficiently and on time.Subject Matter Expert for Tangential Flow Filtration Skids and Cation Exchange Skid.Compiling production data to incorporate a new method in column efficiency testing: Transitional AnalysisPacked and unpacked multiple columns

•Provides general support to all Operating Areas, e.g. Manufacturing, Warehouse, Maintenance, Support Labs•Collaborates with Technical Operations to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation and data management•Partners with Operational Excellence to implement improvements•Writes, updates, and reviews Standard Operating ProceduresSupports business improvement efforts•Supports inspection readiness and actively supports internal audits and regulatory inspections

-Supervised and lead all protein purification operations for various FDA approved drug products (Erbitux, Cyramza, Portrazza, Lartruvo, Emgality, Trulicity and Bamlanivimab)-Managed a team of 10+ through the daily purification operations of two 11K multi-product suites from harvest to drug substance fill-Coordinated activities cross functionally across multiple groups including process engineering, TS/MS, facilities, validation, metrology, AEG, buffer prep, component prep.-Lead the large-scale packing/unpacking operations for GE Hydraulic Chromaflow & GE Axichrom columns of sizes up to 1.4 meters-Authored SOP’s and Batch Records-Performed post process batch record review and release-Managed daily production floor operations while also promoting a safety culture and mindset-Coordinated with support groups to ensure process continued while complying with cGMP guidelinesInterviewed/hired/onboarded new operators-Completed the commissioning and startup of a new processing suite performing IQ, OQ, and PQ’s on new equipment-Supported the tech transfer of various new molecules into purification area-Coordinated with cross functional groups such as validation, vendors, bioservices, engineering, manufacturing to ensure validation and startup activities met deadlines-Adjusted process schedule to ensure adequate staffing to meet process needs-Prepare and organize production suites to an inspection readiness state

Participated in the Purification operations of more than 5 different cell lines, Including the successful completion of Lilly’s groundbreaking Alzheimer’s drug.Completed Training enabling me to complete deviation investigations, develop CAPA’s and change controls.Completed the commissioning and start up of the new suite, which included IQ, OQ, and PQ’s.Creating schedules for daily operations encompassing all of production.Lead teams of operators to complete validation protocols of the new 1.4m columns, ProtienA and IEX chromatography skids efficiently and on time.Subject Matter Expert for Tangential Flow Filtration Skids and Cation Exchange Skid.Compiling production data to incorporate a new method in column efficiency testing: Transitional AnalysisPacked and unpacked multiple columns