ChiHui (CH) Liang
Sr. Director of R&D / Sr. Director of Biomanufacturing and Development @ Cue Health
About
ChiHui earned his Ph.D. in Chemical Engineering, followed by over a decade of immunology-focused research at leading academic institutions, contributing to projects spanning Immunology, Vaccine Development, Cancer Biology, Multispecific Antibodies, Antibody Drug Conjugates, VHH Nanobody, Antibody Engineering, Genomics, CAR T-Cell Therapy, CRISPR-Cas Gene Editing, NGS, Non-canonical Amino Acids (ncAAs), Glycan Microarray, PK/PD Analysis, Oligonucleotide therapy, Cancer Epitopes, B cell sorting, SPPS, LPPS and LNP. A prolific scientist, ChiHui has 50+ peer-reviewed publications, book chapters, and U.S. patents, with a Google Scholar H-index of 31 and 4000+ citations. ChiHui’s publications can be found in the fields of: Life sciences: @Nature immunology (2024), @Science Advances (2020), @Nature (2017), @Nature Microbiology (2016), @PLoS pathogens (2016) @Immunity (2015, 2014), and more. Applied sciences: @Nature Chemistry (2016), @JACS (2010), @Angew. Chem. Int. Ed. (2011), @PNAS (2013), @PLOS one (2014), @Advanced Functional Materials ( 2008, 2006), @Applied Physics Letters, @Nanotechnology (2006). @JPC of Solids @IEEE (2006), and more. Beyond academia, ChiHui is a biotech leader in ADC, AOC, antibody discovery and manufacturing, with expertise in CMC development, technology transfer, regulatory strategy (FDA submissions, CMC requirements), and bioprocess scale-up. He specializes in design control, pFMEA risk assessment, process validation (IQ/OQ/PQ), manufacturing execution systems, and Lean Six Sigma methodologies.
United States
San Diego
Biotechnology
Organization Skills, Throughput, Advanced Process Control, Small Molecules, Resolving Issues, Presentation Skills, Display Technologies, Project Teams, Pre-clinical Studies, Thinking Skills, Candidate Selection, Technical Documentation, Batch Records, Regulatory Filings, Regulatory Submissions, Process Validation, Formulation, Aseptic Processing, Chemistry, Manufacturing, and Controls (CMC), Portfolio Management
Experience

Sr. Director of R&D / Sr. Director of Biomanufacturing and Development
San Diego, California, United States
· A highly motivated immunologist with expertise in leveraging automation to enhance and expedite the discovery pipeline. Demonstrated success in leading high-performing teams, optimizing research efficiencies, and implementing cutting-edge molecular biology techniques. · Oversee, tailor, and maintain 12 Tecan Fluent Labwerx Automation for candidate discovery, assay analysis, and automated biomanufacturing. · Managed the development and optimization of antibody screening formats and immune repertoire mining. · Lead functional teams in exploring and developing ADCs and multi-specific antibody. · Development of site-specific Antibody-Drug Conjugates. · Create a phage display platform tailored for antibody screening. · Designing oligos, Non-canonical amino acids (ncAAs), and engineered proteins to improve assay performance and accuracy. · Conduct NGS analysis using both short read and long read (Nanopore) technologies. · Implemented Lean manufacturing processes, including daily stand-up meetings, Six Sigma, Kaizen, Kanban, and Gemba walks, resulting in increased efficiency and cost savings. · Proficient in utilizing various antibody display technologies, including phage display for screening naïve libraries, mammalian display featuring full human IgG format, mRNA display with puromycin for genotype-phenotype linkage, and ribosome display for introducing random mutations. · Expertise in qPCR, RT-PCR, dPCR, rapid PCR, multiplex PCR, and isothermal nucleic acid amplification · Led research teams in the development of novel diagnostic assays, focusing on the integration of innovative technologies and scientific excellence. · Established strategic vision for assay development, aligning with long-term scientific and commercial goals. · Directed cross-functional teams in the execution of critical projects, ensuring on-time and on-budget delivery of new product initiatives. · Mentored and developed high-performing teams, fostering a culture of continuous innovation.

Director of Research and Development
San Diego, California, United States
· Led the invention and commercializing of the Cue’s product. · Pioneered a cutting-edge diagnostic assay platform, earning recognition as a key innovator within the company. · Improved assay development efficiency through process optimization and the implementation of advanced technologies. · Enhanced PCR assay sensitivity and specificity through innovative optimization techniques. · Streamlined assay development processes, reducing time-to-market while maintaining high-quality standards. · Played a key role in securing FDA approval for multiple diagnostic products, enhancing the company's market presence. · Led the development of a revolutionary product platform (isothermal PCR) in digital health, resulting in the nation's first isothermal PCR molecular diagnostic test available without a prescription to consumers for home use, without CLIA certification. · Led research projects on qPCR, RT-PCR, dPCR, and multiplex PCR. · Demonstrated a track record of expertise in IVD by developing and launching diagnostic assays and instrument platforms, coupled with a profound understanding of advanced technology, regulation, integration, and platform architecture. · Led the development of multiple enzyme-based assays.

Senior Postdoctoral Research Associate
Cambridge, Massachusetts, United States
Joint appointment HIV/AIDS, Global Infectious Diseases -Demonstrates cutting-edge proficiency in crafting and developing innovative protein-based therapies with precise mechanisms of action that align with the desired product characteristics. -Skilled practitioner adept in both in vivo and in vitro antibody discovery platforms, encompassing immunization and display library-based methods. Areas of study encompass: 1 Emerging Infectious Diseases 2 Vaccine Development 3 Applied Immunology Antibody-drug conjugates (ADC), Antibody drug, Drug discovery, R&D, CRO, Antibody Library, Phage Display, Mammalian display, Ribosome display, mRNA display, Antibody Engineering, Antibody Affinity maturation, Antibody humanization, In vitro efficacy screening, in vivo efficacy evaluation, GMP Cell Line Development, Fermentation Process Development, Purification Process Development, High Throughput Screening, Antigen Production, Bispecific antibody and Nanobody.

Postdoctoral Research Associate
San Diego, California, United States
Department of Immunology and Microbiology -Possesses hands-on expertise in immunogen design, structural biology, multispecific compounds, immunocytokines, and Fc engineering for ADC. -Experienced in tasks such as biologics expression, purification, conducting functional screening assays, and carrying out assessments of compound developability. -Comprehension of biologics drug/vaccine/antibody discovery and development processes Skills: 1 B cell priming 2 B cell sorting 3 Antibody engineering 4 P3 Lab (HIV virus, Flu Virus, zika virus 5 T cells and Chimeric antigen receptor T cell design

Academia Sinica Postdoctoral Fellows
Taiwan
Genomics Research Center. Taiwan - Investigated the role of glycosylation in modulating immune responses, leading to the discovery of glycan-specific antibodies with potential therapeutic applications. - Designed glycan profiling assays to assess glycosylation patterns on antibodies, antigens, and immune cells. - Implement glycan modification procedures on the Fc region of antibodies to facilitate drug conjugation. - Employed innovative glycoengineering approaches to enhance antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities. - Contributed to the development of glycan-based vaccines, utilizing glycoconjugation strategies Skills: 1 Synthetic organic chemistry 2 Glycobiology 3 Glycan epitopes in cancer 4 Glycan microarray
Education

Chemical Engineering
-LNPs -Gene therapy -Drug release - Nanosecond to sub-nanosecond pulsed power - Quantum electronics - Semiconductor devices, CVD, PVD, MBE, PECVD - Nanoscience, Electron-beam lithography, STEM, Multiphoton Microscopy, Cryo-Electron Microscopy, SEM/EDS, TEM - Nanomaterials - Astrobiology
ChiHui (CH) Liang's Contact Information
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