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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)


1
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)




2

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Shawn Lee 11302011

  • 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) 1
  • 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) 2