This is my old resume from my previous experiences in pharmaceuticals.

1. SHAWN LEE
www.teresashawncorp.com
OBJECTIVE:
A scientific position, which will utilize, integrate and advance my professional
training and knowledge in an area of expertise such as those, listed below.
SUMMARY:
· The investigation of batches testing in raw materials, products, and product
shipping study due to Out Of Specification (OOS)
· Apply c-GMP, GLP, Corporate SOP thoroughly; Comply with Quality
Assurance guidelines; Coordinated with manufacture, R&D in problem
solving, and root causes finding in multilateral out of specification (OOS)
investigation.
· Analyze data, write reports to summarize findings and complete
investigations in order to prevent out of specification (OOS) compliant, and
also provide constructive support for a recommendation to improve testing
methods, QA auditing procedures, and process monitoring systems.
· Related experience in analytical chemistry, validation, and data analysis.
· Computer training in Client Server environments, corporate documentation /
records enhancements, and web application developments. My areas of
expertise
Scientific
· Pharmaceutical Research and Development
· Pharmaceutical Quality Control
· Clinical Research
Engineering
· Pharmaceutical Manufacturing
· Chemical Engineering
· Environmental Safety
· Computer Technology
TECHNICAL SKILLS:
Chromatography rp-HPLC, GC, Affinity Chromatography, and
Gel-Filtration Chromatography
Spectroscopy Visible/UV and Atomic Absorption
Gel Electrophoresis SDS-PAGE and IEF
Immunoassay Western Blotting and Threshold-Immuno Ligand
Assay

2. EXPERIENCE:
A Johnson & Johnson Company January 2003 – August 2003
Contract Chemist
Research Scientist Warren, New Jersey
Responsibilities:
• Develop HPLC assay, Elution testing for USP apparatus 4 method on
multi-APIs components within anti-biotic medicines, steroids, and
hormones.
• Applying Polymer coating techniques in formulating APIs and vehicles in
compliance with c-GMP regulation.
CSSC Inc. January 2002 – June 2002
Sr. Validation Scientist Morristown, New Jersey
Responsibilities:
• 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
Organon Inc (Akzo Nobel Company). February 1998- January 2001
Scientist West Orange, New Jersey
Analytical Methods Development Laboratory & Quality Control Department
Responsibilities:
· Conducted method transfer in Follicle Stimulating Hormone products related
to reproduction medicines.
· Collected and evaluated HPLC data to validate testing methods; modified
transfer methods required in IND/NDA submission for liquid formulation
products.
· Modified 0rganic volatile impurities testing methods of raw materials to meet
USP compliance specifications.
· Conducted computer validation in Turbochrom software.
· Evaluated data in Excel spreadsheet, using SAS application for data analysis.
• Conducted Out of specification (OOS) investigation in raw materials related
to OVI impurities.
A Johnson & Johnson Company January 1996- February
1998
Consultant Raritan, New Jersey
Ortho Clinical Diagnostic, Inc.

3. Hemostasis Business Unit-Manufacturing
Responsibilities:
· Investigated chemical residuals in Hemostasis manufacturing devices.
Conducted method development in cleaning validation study in quality
assurance laboratory.
· Initiated an experiment to extract hydrophobic/hydrophilic complex from
surface.
· Designed a unique sample preparation, which was suited for two methods in
each individual testing.
· Collected and evaluated AA or HPLC data to develop and validate testing
methods, which were mandated by FDA in Hemostasis products.
· Used atomic absorption spectrophotometer to analyze residual silica;
applying HPLC analyzed phospholipids for cleaning and process validation.
· Conducted out of specification (OOS) investigation in trace metal
contamination rooted from glass vial’s cap.
Schering-Plough Corp. March 1995- December 1995
Contract Chemist Kenilworth, New Jersey
Schering-Plough Research Institute
Physical and Analytical Chemical Research and Development
Responsibilities:
· Conducted pharmaceutical biotechnology products research related to
formulation degradation study associated with Anti-IL-5, IL-10, and Interferon
drug substances.
· Collected and evaluated HPLC data in HSA-free Interferon for compliance
with specification and stability.
· Using Nitrogen detector to develop and validate testing methods required in
IND/NDA submission for HSA-free Interferon encaptured microspheres.
· Technical training in Integral bench-mounted immunoassay/liquid
chromatography workstation.
Hoffmann-La Roche Inc. January 1991- March 1995
Bioproduct Research & Development Laboratory
Analytical Quality Control Department
Associate Scientist Nutley, New Jersey
Responsibilities:
· Conducted pharmaceutical biotechnology products research related to quality
control requirements associated with Interferon products.
· Collected and evaluated HPLC data to develop and validate testing methods
required in IND/NDA submissions for HSA-free pegulated Interferon
formulations.
· Conducted out of specification (OOS) investigation in process improvement
related to fluoride containing PVC pipeline.

4. · Using Atomic absorption Spectrophotometer analyzed trace metal levels to
develop copper analysis methods for cleaning validation required in PLA
submissions for Interferon fermentation’s and purification’s.
· Conducted routine tests of bulk materials, raw materials, ingredients and
dosage forms to evaluate compliance with specifications and stability.
Hoffmann-La Roche Inc. January 1989- January
1991
Analytical Environmental Laboratory
Environmental Safety Department
Assistant Environmental Scientist Roche Inc. Nutley, New Jersey
Responsibilities:
· Conducted water/hazardous waste analyses to evaluate trace metals,
biological oxygen content, pH, fluoride, and chloride.
· Designed data acquisition and management systems, which included data
graphing and mathematical modeling components.
· Conducted data management by using Symphony software.
· Designed laboratory information management system in computer to keep
track of analytical results.
Taste and Smell Clinic,
Georgetown University Medical Center. January 1986- July 1988
Nutritionist Washington DC
Responsibilities:
· Patient contact in studies of human zinc nutrition.
· Used Nutritionist III software program in computer analysis of diets and
clinical nutrition.
Georgetown University Hospital. May 1984- December1985
Biochemist Washington DC
Responsibilities:
· Participated in research program on chemicals related to human taste
function in metal metabolism.
· Used radioisotopes to study metal binding to purified taste receptors to
elucidate metabolic pathways in taste perception.
· Extensive experience in biological analysis of biological fluids.
Ohio University March 1983- May 1984
Chemical Engineering Department

5. Research Assistant Athens, Ohio
Responsibilities:
· Conducted thesis study of sulfur dioxide removal with char from flash
carbonization process.
· Applied theoretical design knowledge and experience in research and
development of fluidization process.
· Related experience in automated unit operation and computerized simulation
process.
Chemical Engineering Department January 1979-August
1982
Taipower Nuclear Power Plant.
Radiochemist/Health Physics Taipei, Taiwan
Responsibilities:
· Conducted reactor water quality control, environmental safety monitoring
surveillance and
· Waste water treatment.
· Conducted radiation regulation control, radiation safety surveillance including
areas and human body radiation prevention.
· Radioactive materials and hazardous waste treatment.
EDUCATION:
· Ohio University. Athens, Ohio (1982-1984)
M.S. in Chemical Engineering
· Tamkang University. Taiwan (1975-1979)
B.S. in Chemical Engineering
· New Jersey Institute of Technology. Newark, New Jersey
( 9/90-12/90)
Course in Instrumentation Analysis in HPLC, GC, AA, and NMR
· Chubb Institute. New Jersey (1999-2000)
Network Technology & Personal Computer Technology
• Chubb Institute, New Jersey (1/01- 8/01)
Web Development & Business Programming

6. University of Medicine and Dentistry of New Jersey (2004 - 2006)
Health Care Informatics
Courses: Visualization in Biomedical Sciences; Research Methods in
Health Sciences; Topics in Bio-informatics; Essentials of Health Computer
Science; Health Care Information Systems; Intro to Bio-informatics
COMPUTER RELATED EXPERIENCE:
• Conducted computer validation in Turbochrom software, evaluated data in
Excel spreadsheet. Using SAS application for data analysis.
• Basic hardware, installation, configuration, maintenance and troubleshooting.
• Install and configuration NT workstation and Server PDC/BDC/ MEMBER
Servers.
• Novell 4.11 administration, NDS design, Server installation and configuration,
implementation of TCP/IP and NetWare Application Launcher (NAL).
• Integrated Novell and NT in a mixed environment.
• NT Domain Management.
• Computer application in Excel, Lotus 1-2-3, WordPerfect, Word, Power Point,
Turbochrom Chromatography Integration Method, Laboratory Information
Management System, SAS software, Symphony software.