
Chun Y.
Senior Director, Antibody Engineering and Drug Delivery
About
• R&D scientific leadership with 20 years of experience in biotechnology and biopharmaceutical industry with a proven tracking record of delivering results; • Dedicated and innovative scientific leader and team player with extensive practical experience on therapeutic antibody development, antibody engineering/humanization, phage display platforms for Fab and scFv, antibody affinity maturation in vitro, antibody drug biophysical characterizations, drug cGMP production, QC release/drug purity and stability test, preparation for IND filling, etc. with developing experience of a phase I trial therapeutic antibody M22; • Extensive practical experience on preclinical assay development for biomarkers/drugs discovery, protein binding assay, potency assay, immunogenicity assay, drug PK/PD assay, and drug toxicity study/bio-distribution assay for a phase I humanized antibody M22; • Extensive research experience and knowledge on cell signaling pathways related to the immune response, oncology, ADC drug delivery, ADCC and CDC functions related to immunotherapy, checkpoint related immune targeting cancer and inflammation, bispecific antibody, et al; • Excellent large project management and communication skills, with extensive experience in communicating with external customers as well as internal manufactory and quality control stake holders. Extensive experience in CMO/CRO project and lab management. • Extensive experience on collaborating with manufactory and quality control departments to ensure seamless technology transferring, continued technical support (product quality control investigations), supplier validations/qualifications, as well as manufactory process development and validations, et al;
United States
San Diego
Pharmaceuticals
Molecular Biology, Cell Biology, Biochemistry, qPCR, PCR, Genomics, Protein Chemistry, Cell Culture, Purification, Western Blotting, Lifesciences, Confocal Microscopy, Protein Purification, Genetics, Biotechnology, Transfection, Protein Expression, DNA, ELISA, Microscopy
Experience

Senior Director, Antibody Engineering and Drug Delivery
Nitto BioPharma, Inc.
San Diego, California, United States

Director, Antibody Engineering and Technology
Nitto BioPharma Inc. (NBPI)
San Diego, California

Director, Therapeutic Antibody Engineering and Preclinical assay development
In Prism, we are working on therapeutic antibody development for drug delivery target on solid tumors, including preclinical antibody discovery, development, antibody engineering/humanization, top candidate affinity maturation, characterization, preclinical assay development, drug pharmacological studies, drug potency assays for translational research, etc. • Developing mAb hybridoma for drug delivery targets; • Antibody engineering and humanization: these include cloning mAb genes from hybridoma, expressing recombinant mAbs in ExpiCHO system, lead recombinant mAb humanization/optimization for minimizing immunogenicity with protein modeling software, and Fc engineering for improving or silencing effector functions and drug conjugation functions, improving drug stability, et al; • Naïve and immunized phage-display scFv and Fab library construction and panning/screening, in vitro affinity maturation; • Biophysical characterization for recombinant mAb and humanized lead mAbs: these include size-exclusion chromatography(SEC) with several detectors (diode array UV/visible, Multiple Angle Light Scattering (MALS), Quasi-Elastic Light Scattering (QELS), and refractive index (RI)); reversed phase (RP), hydrophobic interaction chromatography (HIC), and ion-exchange chromatography; the biophysical property of binding affinity evaluation by one site binding ELISA and Biacore label-free real time platform; the specificity confirmation with ELISA against recombinant target protein and WB against both recombinant protein and cell lysates, et al. • Developing preclinical in vitro/in vivo assays to characterize the Ab potency; PK/PD studies, toxicity study/drug bio-distribution, et al; • Managing the communication with CMOs for protocol transfer and cGMP production of therapeutic antibody; • Working closely with chemist group for ADC; • Working closely with in vivo biology group to characterize the ADC potency in vivo;

Senior Manager/Manager, R&D Antibody Development/validation
Temecula, CA
My roles and responsibilities in EMD Millipore/MilliporeSigma are focusing on following areas: • Assay development and validation for all in house/OEM/licensed Abs, including cell based assay, immune-based assay, multiplex assay, IVD assay, CHIP assay, etc; • Antibody validations for all in house/OEM/licensed Abs. Extensive experience in Ab validation models and process, including ELISA, WB, IP, ICC, IHC, FLOW, etc.; • Building and developing antibody target validation system in Blot/lysate Library Core, consistently supplying quality-controlled stimulated cells, lysates, PVDF blots for RD, QC, MF validations. • New polyclonal and monoclonal antibody development: antigen design; animal immunization; serum/supe screening using different cellular models with different applications; hybridoma cell fusion/cloning; antibody purifications; et al; • New antibody development technologies, including antibody engineering and developing recombinant rabbit monoclonal antibodies in CHO Cells using UCOE system; new cell assay technology evaluations, et al; • Serving as supervisory role for QC department for bioscience product quality control and validation; • Working closely with cross-functional teams to achieve the pre-defined goals.

Post Doc
La Jolla Institute for Allergy and Immunology
Functional analyses of protein degradation in immune system.

Graduate student
University of Illinois at Urbana-Champaign
Chun Y.'s Contact Information
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