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簡孝誠(Siao-Cheng Jian)

I have nearly 7 years of experience in leading QA team to conduct and maintain quality management system, and handling audits of the third-party, clients and the regulatory authority. During my tenure of QA, I successfully completed 3 laboratory accreditations and 1 ISMS certiêcation. Prior to QA, I had more than 5 years of experience in research and development of new drug.

New Taipei City,TW

0937813514
[email protected]

Experience

行動基因生技 ACT Genomics Co. Ltd

Associate QA Director

Dec 2014 ~ Aug 2021

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.

(8.) Lead QMS conductions for overseas laboratories (Japanese and Hongkong) and partner’s laboratory (China).

[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.

台灣東洋藥品 TTY Biopharm

Scientist

May 2009 ~ Nov 2014

(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

賽亞基因科技 Vita genomics

Assistant Scientist

Sep 2007 ~ Apr 2009

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

中央研究院 Academia Sinica

Research assistant

Oct 2006 ~ Aug 2007

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

學歷

CHUNG SAN MEDICAL UNIVERSITY, 哲學博士(PhD), Genomic Toxicity(肄業), 

2003 ~ 2006


CHUNG SAN MEDICAL UNIVERSITY, M.S. in Medical and Molecular Toxicology, 2001 ~ 2003


TUNGHAI UNIVERSITY, B.S. in Food Science, 1996 ~ 2000


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