Leslie Fabiola Paredes Chumbirizo
About Leslie Fabiola Paredes Chumbirizo
Leslie Fabiola Paredes Chumbirizo is a Senior Manager of Process Engineering at Kite Pharma, where she has effectively reduced overdue deviations from 100% to 9% in two months. She has a background in Biochemistry and Molecular Biology from the University of California, Davis, and previously worked as a Quality Assurance Specialist at Genentech.
Work at Kite Pharma
Leslie Fabiola Paredes Chumbirizo has served as Senior Manager of Process Engineering at Kite Pharma since 2017. In this role, she has successfully closed over 80 deviations and 40 Corrective and Preventive Actions (CAPAs). Her efforts have led to a significant reduction in overdue deviations from 100% to 9% within a two-month period. She has authored multiple Master Production Records (MPRs), Standard Operating Procedures (SOPs), and forms, including documentation related to the reclassification of commercial excess Peripheral Blood Mononuclear Cells (PBMCs) and the restart of the Day 0 process with excess apheresis.
Previous Experience at Genentech
Before joining Kite Pharma, Leslie worked as a Quality Assurance Specialist at Genentech from 2014 to 2017. During her tenure in South San Francisco, she focused on quality assurance processes and contributed to maintaining compliance with industry standards. Her experience at Genentech provided her with a solid foundation in quality management within the biopharmaceutical sector.
Education and Expertise
Leslie earned her Bachelor's degree in Biochemistry and Molecular Biology from the University of California, Davis, where she studied from 2007 to 2013. Her educational background has equipped her with a strong understanding of biochemical processes and molecular biology, which she applies in her current role in process engineering.
Process Engineering Contributions
In her role at Kite Pharma, Leslie has implemented change controls for independent samples on Day 0 and Day 2, as well as reclassification and resampling processes. She has managed critical deviations related to equipment failures, including issues with CRF, SEPAX, LN2, Nucleocounter, and CO2 incubators. Additionally, she has developed procedures for the resampling process during and outside of manufacturing operations.