Belle W. Email and Phone Number

- Develop and optimize T cell gene editing and manufacturing platforms via viral and non-viral gene delivery approaches;- Characterize starting materials, in-process samples, and final products through: * T cell phenotypes/activation/proliferation analysis * Co-culture and killing assays * Gene editing efficiency/stability analysis * Vector copy number analysis * Statistical analysis- Frequently used bioanalytical and data analytical techniques include: * Multi-color flow cytometry and flow data analysis (BD Fortessa, BD Canto, Thermo Fisher Attune, Beckman Coulter CytoFlex, FlowJo, CytExpert) * Molecular biology (ddPCR, qPCR, RNA-seq, NGS: vector copy analysis, residual DNA analysis, gene expression analysis) * ELISA, MSD, Luminex, Ella; * Lab automation (Tecan Liquid Handler, Agilent Bravo) * Data Science: R, Python, SAS, SpotFire, multivariate analysis, linear regression, machine learning

• Built and led an Analytical Logistics team of four members from the ground up to support analytical testing, scheduling, sampling, data analysis, reporting, biospecimen management, reagent management, lab management, and resource/project monitoring.• Configured and implemented a sample and reagent management system on FreezerPro for the department within three months and transferred the knowledge to Vector and T Cell Process Development.• Established over 10 business processes for analytical operations, streamlined the workflows, and reduced 10 -15% of resources.• Authored, reviewed, and approved SOPs, work instructions, data analysis reports, and business-enabling documents.• Evaluated study plans and sampling/testing plans submitted by Process Development, Quality, and Manufacturing.• Designed and implemented a barcode system for sample management, reagent inventory management, and ELN data entry to improve operational efficiency.• Work with the IT department to resolve lab computers, software, internet, and cloud storage issues.• Evaluated LabKey, Biovia Unified Lab, Benchling ELN, and barcode systems to establish an efficient workflow for sample/reagent/equipment management in Analytical Development.• Built a SpotFire dashboard to monitor analytical testing progress and resource usage.• Developed and implemented a Smartsheet tool for communicating service requests made by Process Development, Analytical, and Manufacturing that come to the Analytical Testing team.

Performed analytical assays, including cell culture, ELISA, qPCR/ddPCR, and flow cytometry for CAR-T cell process development and product characterization studies.• Optimized cell-based potency assay and host cell DNA qPCR assay.• Prepared cell banks and passaged cancer cell lines.• Initiated a data harmonization project and collaborated with different functional groups to design sample/instrument/reagent/batch naming conventions and prepare data reportable templates for various bioassays. This ensures that the collected data are machine-readable and ready for analysis and visualization.• Designed ELN templates to standardize testing workflows and data entry for analytical testing.• Reviewed analytical data and ELN documentation.

• Performed analytical testing to characterize biological products with ELISA, rDNA, HPLC, UPLC, and CE-SDS assays.• Designed experiments and performed pilot studies to optimize analytical procedures.• Presented results in cross-functional group meetings and established seamless collaborations with the method development group and process development group to refine methods, troubleshoot difficult samples, and ensure delivering reliable results.• Trained on ELN, GLP, GMP, and LIMS.

• Characterize elemental distributions in single cells and tissues with various elemental analysis methods, including ICP-MS, ICP-OES, fluorescence microscopy, TEM/EDS, cryo-EM, and X-ray fluorescence microscopy• Analyze RNA-seq data with gene enrichment, protein interaction network, metabolic and pathway enrichment analyses

Purified and quantify proteins and variants with FPLC, HPLC, AAA, and characterized proteins with SEC-MALLS, MALS-QELS, LC-MS, MALDI-TOF, and ESI-MS• Characterized protein structure with X-ray crystallography and NMR• Studied gene regulation with RNA-seq, RT-PCR, gene reporter assays, and phenotypic study• Expressed, purified, and analyzed RNA and DNA with PAGE, CE, fluorescence stain, and HPLC

• Established and optimize the quantitative fluorescence-labelled DNase I footprinting method to analyze Protein-DNA and drug-DNA interactions • Established and optimize the quantitative fluorescence-labelled DNase I footprinting method to analyze Protein-DNA and drug-DNA interactions

• Purified and characterize a novel reductase, identified its cofactor with MALDI-TOF, and performed kinetics assay to decode the enzymatic mechanism• Identified a novel transcription factor, and characterized protein-DNA interaction and metal cofactor-protein interaction with Native-PAGE, fluorescence anisotropy assay, DNaseI footprinting assay, EMSA, ITC, and SPR• Characterized metal-binding proteins with CD/MCD, EXAFS, XAFS, Mossbauer, and EPR• Determined in vivo functions of proteins through genomic manipulation and phenotypic study, and constructed a mutant library containing over 100 genetic mutants in bacteria.