QC Assay Development for CAR-T

•Led late stage development and transfer activities for an NGS based liquid biopsy assay from R&D to CLIA/CAP clinical labs (BSL-2), including preclinical study and LDT analytical validation. Responsible for drafting SOPs, developing training program and training clinical lab operators, LIMS integration, workflow optimization, equipment functional qualification, reagent design transfer and QC development and method transfer.•Supervised junior research scientists on NGS assay transfer, equipment functional qualification, troubleshooting and data analysis.•Improved NGS sequencing sample balance by reducing PicoGreen assay low-end quantitation bias for up to 80%.•Designed, executed and managed the stability program for intermediate products generated from an NGS based assay and analyzed and interpreted complex sequencing data in JMP to support IDE.•Identified and closed gaps in LDT analytical validation by redesigning experiment and isolating problematic reagents to ensure compliance with CLSI standard and smooth execution.•Utilized DOE to refine genomic DNA shearing conditions, reducing the minimum patient sample concentration requirement by 60% and significantly improving assay input tolerance.•Established correlation between qPCR and PicoGreen assay on PhiX quantitation and consolidated quantitation methods, resulting in more consistent sequencing metrics from run to run.•Identified root causes of repeated control failure in DNA library quantitation assay through data analysis and collaborated with QC and automation teams to orchestrate counter measurements within 3 weeks.•Developed incoming specifications for critical oligonucleotides by establishing a correlation between NGS assay performance metrics and oligo MW, reducing lengthy and expensive functional QC.•Facilitated several R&D sub-teams on DOE and data analysis, mentored R&D members on JMP.•Drafted analytical report section of IDE submission for an NGS based multi-cancer early detection assay.

•Collaborated with QC and R&D on an NGS based CE-IVD CDx device (Oncomine Dx Express Test) launch. Responsible for analytical QC methods transfer and life cycle management.•Assisted with QC OOS investigation for functional / analytical assays, including qPCR, dPCR, bioassay, ELISA and enzyme assays. Led CAPA activities that improved assay workflow and performance.•Led cross-site transfer for an RUO NGS based Oncology assay product line, responsible for functional method transfer verification, troubleshooting and training.•Served as R&D pitch leader for the entire Luminex (multiplex bead-based ELISA) product portfolio cross-site transfer worth of $3MM annual revenue. Responsible for authoring transfer validation protocol, data review and product life cycle management using Agile PLM.•Provided technical expertise and leadership in revamping assay stability program to deliver more robust assay with 75% shorter timeline.•Streamlined manufacturing data analysis and documentation procedure by implementing new technologies in batch record spreadsheet, resulting in more than $100K annual savings.•Supervised three scientists with different levels on developing / validating various types of assays.•Developed a qualitative fluorescence-based QC method on Biomek NX automation platform to ensure the quality of oligonucleotides products, resulting in less OOS occurrence.•Identified root causes of reagent QC release failures, implemented both short- and long-term solutions and documented changes to ensure the successful launch of a CDx device (Oncomine Dx Target Test).•Spearheaded sourcing project to identify alternative recombinant proteins and antibodies suppliers, including screening, validation and forecasting, resulting in more than $300K annual savings.

•Oversaw proximity ligation immunoassay product line development by providing technical consultation to ensure robust assay performance, smooth technology transfer and V&V.•Provided technical guidance to the manufacturing leadership team on resolving routine immunoassay kit production issues, offering both immediate and long-term solutions to address backorders.•Optimized immunoassay kit performance and manufacturability through DOE, resulting in more than 20% COGs saving.•Assisted product manager and QA to address customers’ needs and resolve complaints.•Identified risks in processes (conjugation/lyophilization) through pFMEA and orchestrated mitigations.•Supervised junior scientists on immunoassay development / transfer / V&V.

•Collaborated with senior team member on transferring and launching new Luminex immunoassay kits.•Scaled up conjugation procedure to reduce labor cost by $100K annually and increase productivity by more than 3 folds.•Improved performance of existing products through redevelopment within a few months.•Trained two team members on immunoassay development, antibody conjugation and data analysis.•Assisted QC group with troubleshooting cell-based bioassay as well as various PBMCs stimulations.

•Polymer surface functionalization and characterization.•Identified failure mode of a heamocompatible biomaterial and improved its stability and surface property through new conjugation chemistry.•Designed a robust chemiluminescnce assay to investigate kinetics between biological molecules and a modified biomaterial.•Established and validated a complex kinetic model for transnitrosation reaction with various co-factors and determined key reaction parameters.•Developed a 3-D model to predict biomaterial surface drug release rate when the material is interacting with blood.

•Constructed, amplified and purified recombinant DNA by molecular biology techniques.•Expressed the target proteins using bacterial fermentation at bench scale.•Recovered and purified target proteins by affinity or size exclusion chromatography. •Improved the protein refolding process by 40% through gradient dialysis and refolding co-factors.•Synthesized novel anticancer medicine and performed initial animal test.•Developed conjugation procedure to attach small molecules to proteins/enzymes.•Created an easy and dependable electrophoresis method to demonstrate that small molecules were successfully conjugated to target proteins.•Prepared polyclonal antibodies using animals and assayed the antibodies by ELISA.•Developed several commercialized immunoassay kits and improved the product shelf life. •Supervised three apprentice level workers for protein expression, antigen preparation and anti-tumor drug synthesis.

•Improved fermentation broth pretreatment process by coupling flocculation with filtration.•Optimized pH gradient to recover the L-Arginine from fermentation broth by ion-exchange chromatography and performed scale-up for the process.