Han-Yu Chuang

Vice President Of Technology at Guardant Health
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Contact Information
us****@****om
(386) 825-5501
Location
San Diego, California, United States, US
Languages
  • Taiwanese -
  • Chinese -
  • English -

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Vera Nakova Ortiz

I recommend Han-Yu as a stellar asset on any team. She was nominated by the R&D Head at Illumina to serve as an expert advisor to the Medical, Legal and Regulatory (MLR) Team in the content approval process. Bringing Han-Yu into the often challenging MLR review meetings was a game changer! Her in-depth knowledge of genomics, technology, and bio-informatics as well as her solution-oriented mindset were invaluable in accelerating business-critical content reviews and approvals. Her input resolved bottlenecks, brought clarity, fostered collaboration, secured compliance and as a result, expedited our products' time-to-market and adoption. I hope to work with her again!

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Experience

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Vice President Of Technology
      • Jul 2022 - Present

    • Senior Director, Bioinformatics
      • Sep 2020 - Jul 2022

    • United States
    • Veterinary Services
    • 1 - 100 Employee
    • Scientific/Technology Advisor
      • Jun 2019 - Present

      - Provide expert consultation to the executive team on strategic planning for development of cutting-edge “omics” diagnostic assays in veterinary medicine - Provide technical consultation to a team of genomics platform developers, bioinformaticians, and software engineers in the creation, testing, maintenance, and versioning of veterinary clinical “omic” diagnostic pipelines, assays, and laboratory systems. - Provide expert consultation to the executive team on strategic planning for development of cutting-edge “omics” diagnostic assays in veterinary medicine - Provide technical consultation to a team of genomics platform developers, bioinformaticians, and software engineers in the creation, testing, maintenance, and versioning of veterinary clinical “omic” diagnostic pipelines, assays, and laboratory systems.

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Head of Bioinformatics, Data Science, and Software
      • Oct 2019 - Sep 2020

      - Responsible for building up the informatics team, attracting and growing talents, and planning for project timeline and resource allocation - Led a team of bioinformaticians, biostatisticians, and software engineers in the development of statistical analyses, bioinformatics methods, and informatics systems for clinical test optimization with fetal cell based technology and next-generation sequencing (NGS) for comprehensive non-invasive prenatal testing - Evaluated and architected… Show more - Responsible for building up the informatics team, attracting and growing talents, and planning for project timeline and resource allocation - Led a team of bioinformaticians, biostatisticians, and software engineers in the development of statistical analyses, bioinformatics methods, and informatics systems for clinical test optimization with fetal cell based technology and next-generation sequencing (NGS) for comprehensive non-invasive prenatal testing - Evaluated and architected end-to-end data infrastructure to support high-volume clinical tests with cloud computing - Provided technical leadership in the design and analysis of complex experiments during research and development - Devised statistical modelling on technology requirements to fulfill the LDT roadmap - Collaborated with external teams and manage vendor relationship to deliver startup milestones fast with quality Show less - Responsible for building up the informatics team, attracting and growing talents, and planning for project timeline and resource allocation - Led a team of bioinformaticians, biostatisticians, and software engineers in the development of statistical analyses, bioinformatics methods, and informatics systems for clinical test optimization with fetal cell based technology and next-generation sequencing (NGS) for comprehensive non-invasive prenatal testing - Evaluated and architected… Show more - Responsible for building up the informatics team, attracting and growing talents, and planning for project timeline and resource allocation - Led a team of bioinformaticians, biostatisticians, and software engineers in the development of statistical analyses, bioinformatics methods, and informatics systems for clinical test optimization with fetal cell based technology and next-generation sequencing (NGS) for comprehensive non-invasive prenatal testing - Evaluated and architected end-to-end data infrastructure to support high-volume clinical tests with cloud computing - Provided technical leadership in the design and analysis of complex experiments during research and development - Devised statistical modelling on technology requirements to fulfill the LDT roadmap - Collaborated with external teams and manage vendor relationship to deliver startup milestones fast with quality Show less

    • Switzerland
    • Biotechnology Research
    • 700 & Above Employee
    • Head of Bioinformatics Market and Application Development, Sequencing Solutions
      • Apr 2019 - Oct 2019

      - Led ~30 bioinfomaticians and biostaticians across six Roche sites in 3 continents to support research and early development, rigorous product development process, and post-launch product care for NIPT and reproductive health, oncology molecular diagnostics, and NGS library prep and target enrichment solutions - Led bioinformatics product development for IVD grade end-to-end clinical sequencing solutions and LDT component kits - Led bioinformatics support in product development for… Show more - Led ~30 bioinfomaticians and biostaticians across six Roche sites in 3 continents to support research and early development, rigorous product development process, and post-launch product care for NIPT and reproductive health, oncology molecular diagnostics, and NGS library prep and target enrichment solutions - Led bioinformatics product development for IVD grade end-to-end clinical sequencing solutions and LDT component kits - Led bioinformatics support in product development for alternative high-throughput molecular profiling platforms - Led bioinformatics and biostatics data analysis to support medical and scientific collaboration for prenatal care and oncology - Planned budget for bioinformatics development with the understanding of interplay between product development timeline and strategic priorities

    • Director, Bioinformatics and Biostatistics, Sequencing Solutions
      • Jun 2018 - Apr 2019

      - Stabilized a team of bioinformaticians, biostatisticians, and software engineers during the key personnel departure (post Ariosa acquisition) - Represented Software and Bioinformatics function in lifecycle teams to mitigate project risks, prioritize resource utilization, and increase employee engagement - Worked with Software and Bioinformatics leadership team on improving organizational operation efficiency - Proposed sustainable solutions to senior management on IVD kit expansion… Show more - Stabilized a team of bioinformaticians, biostatisticians, and software engineers during the key personnel departure (post Ariosa acquisition) - Represented Software and Bioinformatics function in lifecycle teams to mitigate project risks, prioritize resource utilization, and increase employee engagement - Worked with Software and Bioinformatics leadership team on improving organizational operation efficiency - Proposed sustainable solutions to senior management on IVD kit expansion and new NGS testing menu in CLIA lab portfolio planning - Led bioinformatics support in product development projects of end-to-end solutions for next-generation Harmony NIPT tests - Led bioinformatics support in product development for alternative high-throughput molecular profiling platforms - Led biostatistical analysis on Harmony on-market microarray products to provide quality monitoring for CLIA lab operation and reagent manufacturing, to support NIPT medical affair collaboration, and to address technical questions from regulatory submission in US and outside - Led bioinformatics support to validate Avenio ctDNA and FFPE products and launch for oncology pharma services in CLIA - Led bioinformatics support in collaboration with pharma partners on minimal residual disease monitoring and personalized cancer vaccine

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Senior Manager, Bioinformatics and Genomic Applications Partnerships
      • Aug 2017 - May 2018

      - Represented Illumina in FDA-led consortia effort SEQC2 as the main contact for all working group involvement in WGS, targeted seq, methyl-seq, and bioinfo - Led Illumina KOL collaboration with Human Vaccine Project for affordable immune repertoire sequencing, with Zhongshan hospitals in Shanghai China for immuno oncology biomarker identification, and with Shanghai CDC for microbial sequencing - Served as Illumina’s technical ambassador to interact with China government bodies including… Show more - Represented Illumina in FDA-led consortia effort SEQC2 as the main contact for all working group involvement in WGS, targeted seq, methyl-seq, and bioinfo - Led Illumina KOL collaboration with Human Vaccine Project for affordable immune repertoire sequencing, with Zhongshan hospitals in Shanghai China for immuno oncology biomarker identification, and with Shanghai CDC for microbial sequencing - Served as Illumina’s technical ambassador to interact with China government bodies including CFDA and NCCL and gave scientific talks in industry meetings - Interacted with pharma partners, reference/LDT labs, and regulatory bodies in the CDx development to bridge gaps in technical understanding, lab practice, and clinical trial needs - Engaged customers as subject matter experts in marketing activity and addressed customer feedback on Illumina products

    • Senior Manager, Bioinformatics, Oncology
      • Jul 2016 - Aug 2017

      - Designed and launched TruSight Tumor 170 (hybrid capture based) - Selected and built a team of bioinformatics scientists. Developed direct reports in to front-line functional/project managers - Proposed NGS products in portfolio planning to senior management for where and what to penetrate the oncology markets next - Scouted and evaluated internal and external technology development for next product planning - Interacted with pharma partners in the CDx development to bridge gaps… Show more - Designed and launched TruSight Tumor 170 (hybrid capture based) - Selected and built a team of bioinformatics scientists. Developed direct reports in to front-line functional/project managers - Proposed NGS products in portfolio planning to senior management for where and what to penetrate the oncology markets next - Scouted and evaluated internal and external technology development for next product planning - Interacted with pharma partners in the CDx development to bridge gaps in technical understanding and trial needs - Advocated the strength of Oncology products to customers and address customer feedback - Led bioinformatics support in NGS assay development and validation as well as informatics optimization for cancer diagnosis using both tissue biopsy and liquid biopsy - Led algorithm development on digital error correction, somatic variant calling, copy number alteration, gene fusion calling, and splice variant calling on FFPE tissues and cell free nucleic acids, given molecular characteristics in different assays, like amplicon vs. shotgun sequencing - Led design and optimization effort for primers, probes, and unique molecular identifiers used in multiplex PCR and hybrid capture based NGS diagnostics for small variant calling, amplification detection, and gene fusion identification - Led pipeline development for automatic data quality analysis to speed up assay development for NGS diagnostics on DNA and RNA libraries from FFPE tissues and cell free nucleic acids - Filed patent applications during product development and collaboration projects - Drafted key concepts in validation strategies for FDA pre-submission - Worked as core team in product development to discuss risk mitigation and provide expert opinions for subteam leads from business development, marketing, pharma alliance, assay, software, quality, manufacturing, regulatory, and IVD to develop gene-panel NGS diagnostics, using multiplex PCR amplicon or hybridization capture, at clinically grade

    • Manager, Bioinformatics, Oncology
      • Sep 2014 - Jun 2016

      Group lead for oncology algorithms and applications Designed and launched Illumina's TruSight Tumor 15 (multiplex PCR based)

    • Bioinformatics Scientist 2, Oncology
      • Apr 2014 - Aug 2014

    • Bioinformatics Scientist 2
      • Aug 2011 - Mar 2014

      - Coordinated Marketing and R&D teams to facilitate new offering in human genome sequencing service - Defined quantitative metrics and develop infrastructure softwares to benchmark NGS data quality - Performed competitive analysis on internal products and platforms to third party technologies such as SOLiD, Complete Genomics, PacBio, and Ion Torrent - Provided guidance on sample prep kit development as well as on informatics pipelines - Facilitated long reads strategies for… Show more - Coordinated Marketing and R&D teams to facilitate new offering in human genome sequencing service - Defined quantitative metrics and develop infrastructure softwares to benchmark NGS data quality - Performed competitive analysis on internal products and platforms to third party technologies such as SOLiD, Complete Genomics, PacBio, and Ion Torrent - Provided guidance on sample prep kit development as well as on informatics pipelines - Facilitated long reads strategies for structural variant calling, haplotying, and genome assembly - Created marketing materials of competitive analysis across technologies - Addressed customers’ requests on data quality analysis in pre- and post- sale inquiries - Mentored junior team members

    • Bioinformatics Scientist
      • Jun 2010 - Jul 2011

Education

  • University of California San Diego
    PhD, Bioinformatics and Systems Biology
  • National Taiwan University
    BS, MS, Computer Science

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