Chenggang Jin
Group Lead, Gene Therapy and Cell Therapy
About
•Translational medicine scientist and immunologist by training with extensive research and diagnostic assay development experience in CLIA/CAP certified clinical laboratory and GLP/GCLP regulated CRO biotech industry. •Deep understanding in human immunology and immuno-oncology with focus on human T cell immunobiology and clinical application in immunotherapy and cell therapy. •Design, develop, validate multicolor flow cytometry assays (up to 18 colors, immunophenotyping, cell signaling by phospho-flow assay, MHC Dextramer and TCR Dextramer assays, receptor occupancy, and cytotoxicity assay), ELISA/MSD/Luminex, ELISPOT assays and transfer to real time clinical sample testing for phase I/II clinical trial projects. qPCR, Western blot, virus packaging, virus purification and functional assays. •Extensive experience in discovering and developing biomarkers for immuno-oncology and targeted therapeutics with innovative scientific solutions in diagnostic immunoassay development and clinical trial Phase I/II study. •Broad knowledge and extensive hands-on experience in the fields of cellular immunology, molecular biology, cell biology, and oncology disease models. •Reputation for strong scientific thinking and data analysis with sustained quality performance. •Demonstrated project/team leadership and interpersonal communication skills.
United States
San Francisco Bay Area
Biotechnology
Immunology, Laboratory Medicine, Medicine, Clinical Laboratory Management, Project Management, Product Development, Product Marketing, Biomarkers, Medical Diagnostics, Test Validation, Tumor Immunology, research and development, Molecular Biology, HIV, T cells, ELISPOT, ELISA, Flow Cytometry, Cell Culture, cell based assay
Experience

Group Lead, Gene Therapy and Cell Therapy
Private Biotech
San Jose, California, United States
● Led projects aiming to develop new viral vectors for gene therapy and cell therapy for cancer. ● virus packaging, virus purification and functional assays. ● Designed and developed a technical platform to evaluate new methods to expand cancer TAA specific CD8+ T cells for cancer immunotherapy. MHC Dextramer and TCR Dextramer techniques to detect antigen specific CD8+ T cells and antigen presenting cells. ● Developed artificial antigen presenting cells (aAPC) for cancer immunotherapy . ● Flow cytometry (Cytek), Western blot, qPCR, plasmid/DNA purification, primary and cell line culture (Human PBMCs, HEK293T, Jurkat, Raji cells). ● Culture of circulating tumor cell (CTC) from human PBMCs. ● Humanized PBMC mouse model to study cancer immunotherapy. ● Manage and communicate with CRO for partnership and collaboration.

Director Scientific Operations
Fremont, California, United States
• Scientific lead with hands-on experience and deep understanding in flow cytometry-based (FACS and CyTOF) assay development, validation, assay transfer, and assay deployment in clinical trial programs. • Supervise the principal scientist team in whole cycle of study initiation, study plan, study conduct and study closure for over 60 active clinical trial studies with focus on Immuno-oncology drug development (Checkpoint inhibitors, kinase blockers, degraders, and CAR-T Cell Therapy). • Hands-on experience in flow cytometry support of CAR-T clinical development including patient screening, in-process CAR-T product characterization, product release assay, post-infusion cellular kinetics. • Lead optimization and implementation of standard operating procedures (SOP), working instructions, templates, processes, communication, and infrastructure within scientific operations. • Work in close collaboration with Compliance (QA/QC), Scientific and Development teams. • Provide direction and mentorship to operational staff to achieve all milestones and deliverables of all projects, including timely initiation and high-quality study data. • Work with Business Development team to deliver on our commitment to customers and look at efficiencies in our current services. • Write and review study-specific workplans, and associated documents for immune monitoring clinical trial programs. • Provide technical and operational guidance to laboratory staff by managing, planning for new projects, overseeing ongoing projects and providing technical/scientific training as well as guidance to the lab team. • Ensure that clinical immune monitoring (IM) programs are conducted in compliance with regulatory requirements (GLP/GCLP, CLIA/CAP), in accordance with clinical protocols and per CellCarta’s SOPs.

Principal Scientist / Director Scientific Research
Redwood City, California, United States
• Lead a flow cytometry team in a GLP regulated lab to execute projects for cell-based assay development and immune monitoring for pre-clinical and clinical trials Phase I/II of novel immuno-oncology drug development such as immune checkpoint inhibitors, dual kinase inhibitors or receptor inhibitors. • Design, develop and optimize flow cytometry-based phosphoprotein detection assay and immune cell proliferation assays for small molecule or antibody drug development such as adenosine receptor A2A inhibitor, PIM/FLT3 dual kinase inhibitor, anti-CD38 antibody, anti-CD137 antibody. • Deep understanding and hands-on experience with flow cytometry (BD FACS Canto II, LSRFortessa X-20, up to 18 color multiple parameters), ELISPOT, ELISA/MSD. • Familiar with GLP requirements and handling clinical human samples such as whole blood, bone marrow, PBMC isolation, T cell (CD4 or CD8 T cells) isolation, NK cell isolation, tumor tissue infiltrating lymphocyte (TIL) isolation and characterization. • Develop flow-based new panels to enrich service portfolio such as Th1/Th2/Th9/Th17/Th22, Treg, and T naïve/central memory/effector memory, DC subsets (mDC and pDC), and MDSC subsets. • Involved in business support, contract draft and decision-making of SOWs (Statements of Work) for customers. • Write/edit assay development reports and SOPs for customer drug development • Team buildup by interviewing candidates and training new employees and lab technical staff for new assay development. • Work internally to update the management about project progress. Present data updates and discuss projects with customers. • Prepare abstracts/publications and present posters in conference/meeting to promote company services, provide scientific and technical support for business development.

Sr. Scientist, Immunoassay Development
Palo Alto, California, United States
• Design, develop, optimize ELISA-based immunoassays, including sandwich ELISA, competitive ELISA. • Pre-validate diagnostic ELISA assays for FDA 510K filing. • Antibody conjugation and purification. • Reagent screening. • Data analysis, interpretation, presentation. • Major achievement: In 12 months, finished 3 immunoassay development and pre-validation for FDA 510K filing.

Technical Supervisor, Clinical Immunology | Director, R&D
Pharmasan Labs. Inc
Osceola, Wisconsin, United States
• Develop new immunoassays, including Luminex cytokine assay, ELISA and ELISPOT assay, Lymphocyte Transformation, T regulatory cell assays, Natural Killer Cell Cytotoxicity, and Flow Cytometric Immunophenotyping Assays. • Supervise and coordinate the day-to-day activities of the Immunology R&D Laboratory in a CLIA/CAP accredited clinical reference lab to ensure efficient and effective deliveries of new assay development. • Complete all required documentation in the absence of the Assistant Director, responsible for the proper performance of all laboratory procedures and reporting of test results. • Review the laboratories test methodologies provided and give direction for methodologies appropriate for the clinical use of the test results. Verify test procedures performed and establishment of the laboratory’s test performance characteristics. • Ensure a Standard Operating Procedure is available to technicians for all procedures, including Equipment Maintenance and Monitoring Logs, Equipment Operation, Corrective Action, Assay procedures, (pre-analytical, analytical and post analytical), General Lab Maintenance, PPE Safety, Waste disposal, MSDS sheets, and all other relevant testing processes. NOTABLE ACCOMPLISHMENTS • Lead the creation of new clinical laboratory assay for Lyme disease. Invented the trademark for the new assay as iSpot-Lyme (Immunospot Assay for Lyme Disease). • Established new clinical laboratory, ELISPOT Laboratory. • Modified and improved the performance of Bio-Rad Lumnix multiple cytokine assay protocol, passed the Cytokine Proficiency Testing. • Implemented the project timeline; spearheaded the development of assay panels for leukocyte phenotyping in clinical studies. • Lead the creation of new assays such as CD107, perforin expression for NK functional activity; wrote Standard Operating Procedures for Immunology lab. • Provided training presentation for laboratory technicians and marketing staff.

Research Associate
Boston, Massachusetts, United States
• Research projects: B cell responses in HIV/SIV infection in human and nonhuman primate; Cloning and expression of monkey antibody Fc receptors and their functions in anti-HIV/SIV infection. • Techniques: Multiple color flow cytometry, cell culture, qPCR, molecular cloning, expression vector construction, protein expression and purification, Western Blot and ELISA. Software: CellQuest/CellQuest Pro, FlowJo, Diva. • Supervision of the research lab.

Postdoctoral Researcher/Assistant Research Scientist
Iowa City, Iowa, United States
• Research projects: Effects of cytokines on human gamma/delta T cells. • Techniques: Multiple color flow cytometry, cell surface and intracellular staining, SCID/Beige mouse model and monkey model. • Research projects: Migratory capacities of human gamma/delta T cells. • Techniques: Multiple color flow cytometry, cell surface and intracellular staining, SCID/Beige mouse model.
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