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Jack Chen (Guang-Zhong, Chen)

Contacts

Phone +886-928-550-996
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Education

M.S. in Microbiology, Immunology and Biopharmaceuticals

National Chiayi University (NCYU) | 2019/09 - 2020/09

B.S. in Microbiology, Immunology and Biopharmaceuticals

National Chiayi University (NCYU) | 2015/09 - 2019/06

Core Competency

IVD Product Development
  • Design & Development
  • ISO 13485
  • ISO 14971
  • IVDR
  • QMS
Molecular Biology
  • DNA/RNA Extraction
  • Cloning
  • Trangenic Strain Construction
  • PCR Applications
  • Reagent Lyophilization
Microbiology
  • Aseptic Techniques
  • Strain Screening
  • 5L Bioreactor Operation
  • Fermentation Technology
Analytical Methods
  • Micro-FTIR
  • Bio-FET
  • SDS-PAGE
  • Western Blotting
  • ELISA

Career

Senior R&D Engineer / R&D Engineer

Novascope Diagnostics Inc.
2023/03 - Present
  • Developed a BCR-based detection platform for Alzheimer's disease biomarkers.
  • Led third-party clinical validation, achieving high correlation (R > 0.9) with market-leading technologies and pg-level sensitivity.
  • Optimized diagnostic workflows, reducing testing time by 50%; designed and evaluated high-throughput testing platforms.
  • Validated surface functionalization and uniformity using Micro-FTIR and established inspection standards.
  • Designed high-stability chemical modification for covalent bonding to enhance chip surface stability.
  • Designed bio-assays (Antigen-Antibody, Nucleic Acid Hybridization) and executed Bio-FET clinical performance trials.
  • Authored ISO 13485 Level 3/4 documentation, facilitating successful ISO 13485 certification.
  • Managed cross-functional technical communication and end-to-end project tracking.

R&D Engineer

Taiwan Advanced Nanotech Inc. (TANBEAD)
2021/11 - 2023/03
  • Optimized automated nucleic acid extraction kits and qPCR assays, matching market-leading performance benchmarks.
  • Spearheaded the development of lyophilized qPCR reagents, achieving 6 months of stability.
  • Conducted recombinant protein production and purification using E. coli systems.
  • Established microbial testing protocols and specifications for raw materials, semi-finished, and finished products.
  • Authored technical documentation for IVDR and EUA, resulting in successful IVDR certification.
  • Maintained Design History Files (DHF), conducted risk assessments, and established product BOMs and labels.

Engineer

Generock Medical Laboratory
2021/06 - 2021/10
  • Planned and established a medical laboratory, including P2 laboratory management systems and infection control workflow.
  • Conducted diagnostic reagent evaluations, troubleshooting, and medical technician training.
  • Managed routine SARS-CoV-2 PCR testing operations and related administrative logistics.

Full-time Research Assistant

National Chiayi University (NCYU)
2020/10 - 2020/12
  • Executed molecular cloning, CRISPR/Cas9 plasmid design, and Candida albicans transgenic strain establishment.
  • Developed craft beverages (beer, wine, mead), focusing on strain selection and optimization.
  • Established a solid-state fermentation platform (Tempeh) and optimized aglycone isoflavone production and sterile control.
  • Instructed brewery workshops and practical brewing courses.

Project Milestones

Bio-FET Based Diagnostic Assay Development

Developed BCR technology for Alzheimer's biomarkers; passed third-party validation with Linkou Chang Gung Memorial Hospital.

2X qPCR Master Mix & Lyophilization

Achieved performance parity with leading brands; liquid version launched; lyophilized version maintains 6-month stability.

SARS-CoV-2 Multiplex RT-qPCR Kit

Completed pre-clinical testing and authored TFDA EUA submission files.

Tissue gDNA Extraction Kit Optimization

Achieved A260/A230 > 1.8 with a streamlined 45-minute extraction protocol.

Customer Visiting & Investigation

Medical Center Collaboration

Defined clinical specifications for Alzheimer's biomarkers in hospital diagnostics.

Taiwan Biobank Integration

Developed a high-volume (4-6 mL) automated blood gDNA extraction kit with yield and purity matching leading brands.

Laboratory Technical Optimization

Provided technical guidance for molecular diagnostics and optimized SARS-CoV-2 platforms to reduce turnaround time.

Publications

Impact of microsatellite CAI variation on susceptibility to environmental stress and the expression of virulence ECE1 gene in Candida albicans (2020)

Investigated the impact of Rlm1p polyglutamine repeats on virulence and drug resistance.

Improving the Aglycone Isoflavone Contents of Tempeh with Rhizopus oligosporus Mutated by Gamma-irradiation (2020)

First author in Journal of Agriculture and Forestry, National Chiayi; improved nutritional value and flavor through strain improvement.

Seminar Posters

Improve protease and lipase activity of Rhizopus oligosporus with γ-ray irradiation (2019)

First author in TTQAS Annual Conference.

The inhibition of Lactic Acid Bacteria Metabolites on Candida albicans growth. (2018)

First author in the 23rd Bacteriology Seminar.