SUMMARY: *Over 20 years of research, development and qualification of hematological diagn ostic tests, instruments and incision devices,

including reagent development, re agent manufacturing, clinical verification, process validation, quality control reagent and test method development, production transfer, FDA 510(k) application , FDA auditing, and production support. *4 years of neuroscience research in neuroanatomy, neurophysiology, nerve regene ration, and intra- and extracellular injection. *5 years of calcification research in intracellular calcium phosphate movement, formation and regeneration using Scanning and Transmission Electron Microscopic Analysis. EXPERIENCE: I. ITC/NexusDX. Edison, NJ The world leader in Point-of-care hematological diagnostic tests A. Sr. Director, Biomedical and Instrument Qualification, R&D (2004-2011) Respo nsible for organizing and maintaining a 10 people Product Development and Suppor t team skilled in new product and platform technology development and manufactur e process verification and validation *Participate on product development teams to build leading edge devices *Lead performance Verification and Validation of devices under development *Lead manufacture process Verification and Validation of devices under developme nt *Establish and validate in-process and finished product QC test method *Lead Non-Conforming Material Report investigation and resolution (Problem Solvi ng, Corrective Action and Preventive Action) *Lead customer complaint evaluations, investigations and resolution *Interact with representatives of R&D, Manufacturing, Quality and Regulatory Aff airs, Sales and Marketing to ensure that design changes due to feature upgrade, cost reduction, etc. satisfy customer requirements Products Released: a. Diagnostic Tests: Coagulation Tests including PT and aPTT for use with fresh blood and citrated blood samples. b. Devices: Coagulation analyzers for use with multi-channel cartridges. c. Data Management software products: Device configuration, lockout control, dat a management and test record reports. Special Honors: One group member received ITC Premier Performer Award for her o utstanding performance and another member received Thoratec Pinnacle Award for h is significant contribution to production process trouble shooting and correctio n. B. Director, Biomedical Research, R&D (1993-2004) Responsible for organizing and maintaining a 6 people Assay Development and Supp ort team skilled in new product formulation development and manufacture process verification and validation. * Participate on assay formulation product development teams to build leading ed ge products * Lead Verification and Validation of reagent products under development * Establish and validate in-process and finished product QC test method * Lead Raw Material Qualification and Characterization and MSDS (Material Safety Data Sheets) * Participate on Non-Conforming Material Report investigation and resolution (Pr oblem Solving, Corrective Action and Preventive Action) * Interact with representatives of R&D, Manufacturing, Quality and Regulatory Af fairs, Sales and Marketing to ensure that formulation changes satisfy customer r equirements

Products Released: a. Diagnostic Tests: Coagulation Tests including PT, aPTT, and ACT for use with fresh blood samples. b. Devices: Coagulation analyzers for use with single channel cartridges. Special Honor: One group member received ITC Premier Performer Award for her ou tstanding performance. C. Senior Research Manager, Biomedical R&D (1991-1993) Responsible for leading Assay Development and Support team in new product formul ation development and manufacture process sand QC method verification and valida tion. * Participate on assay formulation product development teams to build leading ed ge products * Lead Verification and Validation of reagent products under development * Establish and validate in-process and finished product QC test method * Establish Raw Material Qualification and Characterization test methods Products Released: a. Diagnostic Tests: Coagulation Tests including ACT, Thrombin Time, and Fibrino gen Test for use with fresh blood and/or citrated blood samples. b. Devices: Coagulation analyzers for use with test tubes and cartridges. D. Senior Research Associate, Biomedical R&D (1990-1991) Responsible for Assay Development and Product Support of RxDx test tube system. * Lead RxDx formulation development * Lead Verification and Validation of RxDx test tubes * Establish and validate in-process and finished product QC test methods for RxD x test tubes * Establish Raw Material Qualification and Characterization test methods for hep arin and protamine Products Released: a. Diagnostic Tests: Coagulation Tests including Heparin and Protamine Dose Resp onse Tests b. Devices: Coagulation analyzers for use with test tubes. II. Institute of Biomedical Sciences, Academia Sinica, Taipei (1985-89) The most preeminent academic institution in the Republic of China Associate Research Fellow Responsible for organizing and maintaining a team of scientists, graduate studen ts and technicians skilled in neurophysiology and neuroanatomy research. Additional Duties: Director of Electron Microscopy Center Responsible for organizing and maintaining a team of scientists and technicians skilled in scanning and transmission electron microscopy and providing technical services to research projects of the Biomedical Department. Associate Professor, Department of Medicine, Taipei Medical College Teaching Human Anatomy: lectures and labs III. University of South Carolina, Columbia, South Carolina Research Assistant, Electron Microscopy Center (1983-1985) Working with lab manager, scientists and technicians in providing technical serv ices to research projects of the University. Teaching Assistant, Department of Biology (1980-1983) Working with other graduate students in providing Biology 101 lectures and labs.

EDUCATION: Ph.D. in Biology 1980 - 1985 University of South Carolina, Columbia, South Carolina B.S. in Biology 1970 - 1974 National Taiwan Normal University, Taipei, Taiwan ADDITIONAL TRAINING: Project Management: Effective Project Management, Product and Process Leadership , Kerzner Approach to Project Management, Code of Ethics on Interactions with He althcare Professionals, Constraints Management to Product Development, Statistic s in Standards and Standards Development Getting to Precision and Bias, Design C ontrol Concepts and Implementation, Clinical Data Management in Pharmaceutical R &D, etc. Quality System: Investigations & CAPAs with FDA-Recognized Workshops, Conducting and Documenting Investigations, Problem Solving & Decision Making Workshop, Int ernal Auditing for the Medical Device Industry, Utilizing the Six Steps to Six S igma, Drug Product Stability and Shelf Life, Medical Device Reporting (MDR) Upda te, etc. Computer Skills: Microsoft Word, Microsoft Excel, Microsoft Project, PowerPoint, and Analyse-it PUBLICATIONS: 18 Refereed Papers 44 Abstracts/Presentations MEMBERSHIP: American Heart Association (Since 1992) American Society of Hematology (Since 1992) REFERENCES: Available upon request