Jun G. Email & Phone Number

Potomac, MD, US

Gaithersburg, Maryland, United States

QC Assay Development for CAR-T

Baltimore, Maryland, United States

• 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.
• 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.

Frederick, Maryland, United States

• 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.
• 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.

Frederick, Maryland, United States

• 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.

Frederick, Maryland, United States

• 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.

Stillwater, Oklahoma, United States

• 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.

Shanghai, China

• 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.

Shanghai, China

• 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.

Ph.D, Chemical Engineering

Activities and Societies: AICHE

B. Sc, Biochemical Engineering

Education record