Shawn Lee has over 15 years of experience in the bio-pharmaceutical industries as in-house counsel and as an expert consultant and witness. He has worked for companies such as Teresa & Shawn International Corp, Johnson & Johnson, and CSSC Inc, where he specialized in areas like computer validations, SOP protocols, analytical method validations, and in-process validations. He holds a Certificate in Accounting, Taxation and Legal Programs from New York University, an MS in Bioinformatics from New Jersey Institute of Technology, an MS in Chemical Engineering from Ohio University, and a BS in Chemical Engineering from Tamkang University.

1. Shawn Lee
www.teresashawncorp.com
Experience
teresa&shawn int’l corp January 2007 – Present NY, CT, NJ
In-house counsel in bio-pharmaceutical industries in related to computer validations and SOP
protocols consulting. In year of 2002, I was assigned as expert consultant for four months in
Puerto Rico at Schering Plough Pharmaceuticals sites, and Schering Plough is merged with
Merck now.
Expert witness in scientific discovery for forensic accounting and relevant evident in court
A Johnson & Johnson Company January 2003 – August 2003
Research Scientist Warren, New Jersey
Develop HPLC assay, Elution testing for USP apparatus 4 method on multi-APIs components
with anti-biotic medicines, steroids, and hormones.
Apply Polymer coating techniques in formulating APIs and vehicles in compliance with c-
GMPregulation.
CSSC Inc. January 2002 – June 2002
Sr. Validation Scientist Morristown, New Jersey
•Conduct in-process validation in automated monitoring systems
•Conduct analytical method validation related to FDA compliance
•Conduct 21 CFR Part 11 related to data integrity, automatic audit trails documentum
Education
New York University (2008 ~ 2011)
Certificate in Accounting, Taxation and Legal Programs,
CFE
New Jersey Institute of Technology
MS. in Bioinformatics (2008– 2010)
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2. Ohio University, Athens, Ohio (1982-1984)
M.S. in Chemical Engineering
Tamkang University.Taiwan (1975-1979)
B.S. in Chemical Engineering
MEMBERSHIP
American Bar Association, ABA section of Business Law (2003 ~ 2011)
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