Lead a QA Department with three members and in charge of following major tasks. (1.) Lead and coordinate conduction and maintenance of quality management system. (2.) Conduct and coordinate annual internal audit. (3.) Coordiate external audits from the third-party or regulatory authority. (4.) Coordinate client audits to meet client’s requirements (GCP-like and CLP). (5.) Follow-up the handling of nonconfirmity and confirm implementation of CAPA (6.) Review testing method validation. (7.) Control QMS documentation system of procedure, SOP and records [Experience of QMS conudction and maintenance:] 1. ISO17025 2. CAP (College of American Pathologists) 3. CLIA (Clinical Laboratory Improvement Amendment of 1988) 4. TFDA LDTS (精準醫療分子檢測實驗室檢測與服務指引) 5. QSR (21 CFR 820) 6. ISO13485 7. ISO27001 8. Improve procedures to meet GCP-like and GLP for client's requirements.

(I.) Maintain ISO17025 certification 1. Responsible for the Technical Supervisor of Molecular Testing (II.) Design and implement experiments for proof of concept(POC) of new drug. 1. Conduct and validate the analysis method for POC. 2. Plan and implement experiments to study new drugs. 3. Develop testing methods for biomarker analysis. 4. Generate evaluation reports of new drug candidates. ［Experience of projects：］ 1.　Liposomal nucleic acid drug (2011 – 2014) - MOA confirmation and Potency assay development - Design and manage PD study in tumor model - Execute PK method development and in-house PK study - Biomarker development by real-time PCR system (TaqMan, SYBR Green) 2.　A recombinant protein drug (2010 – 2012) - Proof MOA and quality in cancer cell model - Organize in vivo study to evaluate efficacy 4.　A chemical compound to decrease oxidative stress (2011) - Organize a team to evaluate the prevention of Hand-Foot syndrome induced by Doxorubicin in rat model 5.　Pharmacogenetic biomarker development (2009) - Develop gene mutation analysis in FFPE tissue or whole blood

1. Develop genotyping plat form and execute biomarker project 2. Optimize assay protocol for cost down and increasing efficiency 3. Support sales and market team for technique introduction 1. Develop and execute gene mutation system for Family Hypercholesterolemia by using Affymetrix platform and MLPA system. 2. Develop gene array for BRCA1/2 mutation detection in

頁2 1. Produce recombinant plant proteins and analyze the dimer binding activity 2. Lab management