HARRIS SHEN, PHD
714-***-**** ******@*******.***
Summary
Experienced analytical chemistry professional with strong expertise in
method development and validation to support regulatory filings, process
development and formulation development in R&D as well as manufacturing
activities.
Proven ability in planning, managing and executing complex projects
while working with cross-functional teams.
EXPERIENCE
Group Leader, Analytical Services. Amvac Chemical Corp., Los Angeles,
CA 2013-Present
. Provided training, supervision, and technical direction to a group of
analytical chemists;
. Acted as liaison with other groups in Technology Department which
includes Process Chemistry, Formulation Development, Quality Control
and Environmental Services;
. Serviced as Sponsor Representative and Analytical Coordinator for
contract GLP studies;
. Acted as Analytical Service advisor to Director of Technology and
senior management;
. Worked with consultant to update GLP SOP manual to better conform
with OECD guidelines;
. Stayed current on Analytical Services best practices and kept track
of industry trends and developments.
Principal Analytical Chemist. Amvac Chemical Corp., Los Angeles, CA
2011-2013
. Specialized in Regulatory Chemistry & Analytical Development;
. Serviced as GLP Study Director to determine product identity,
composition, stability and other physical/chemical properties for
regulatory filings; authored up to 40 GLP studies each year;
. Developed and validated analytical methods used for raw materials,
intermediate, in-process, finished products and formulation
development;
. Provided daily Regulatory support and supplied technical
documentation for regulatory filings;
. Provided technical support for data comp and enforcement legal cases;
. Provided technical support for contract Toxicology GLP studies;
. Reviewed and performed gap analysis of analytical portion of DMF
submission;
. Conducted on-site method validation training of R&D and QC junior
chemists at three different locations.
Research and Development Chemist. Amvac Chemical Corp., Los Angeles,
CA 2006-2010
. Developed and validated analytical method for process
development in R&D lab and in manufacturing plants;
. Expert in preliminary analysis (5-batch) GLP studies to determine
both active ingredient and impurities present over 0.1% in the
technical products for identification and quantitation;
. Authored analytical registration packages resulted in registering 15+
alternative suppliers of technical materials;
. Performed general/preventative maintenance, calibration and
troubleshoot of analytical instruments;
. Performed QC manager duties when QC manager on medical leave;
. Served as chemistry resource for Registration, production, field
service representatives, customer service, operations and customers;
. Conducted gap analysis for cGMP compliance of existing manufacturing
facilities;
. Conducted air monitoring experiments for various compounds in the lab
and field;
. Active member of ASTM E13 (Molecular Spectroscopy and Separation
Science), E35 (Pesticides and Alternative Control Agents) and E50
(Environmental Assessment, Risk Management and Corrective Action)
committees.
Chemical Sourcing Manager. ChromaDex Inc., Santa Ana, CA 2005-
2005
. Procured botanical reference standards used for pharmaceutical and
nutritional product analyses;
. Ensured the accuracy of technical data and product information;
. Wrote and reviewed SOPs for internal operations;
. Increased efficiency of daily operation through process optimization
and ERP development;
. Maintained existing supplier relationship and developed new low-cost
vendors globally.
Postdoc Research Fellow. RD&E Division. S.C.Johnson & Son, Inc.,
Racine, WI 2003-2004
. Provided analytical services to global consumer product projects;
. Evaluated over twenty alternative suppliers for generic active
ingredients used in consumer products;
. Developed methods and protocols for analytical and registration
purposes;
. Conducted reverse engineering analyses of competitive products with
marketing and formulation teams;
. Performed feasibility and legal compliance analysis of new Insect
Control products;
. Evaluated potential use of new instrumentations and improved existing
methods with new capabilities;
. Accomplished training for employees with various backgrounds to
accelerate technical transfer.
Graduate Research Assistant. Center for Environmental Science and
Technology, Rolla, MO 1998-2002
. Conducted research on a $1.5 Million Small Business Innovation
Research (SBIR) project sponsored by US Air Force and NASA to develop
and commercialize a characterization/monitoring system;
. Used database program and computer modeling for research purposes;
wrote programs for automation control and data analysis;
. Delivered final Mass Spectrometer (MS) based systems and provided on-
site installation and training, resulting in a $3.14 Million
additional funding.
EDUCATION
Master of Science in Industrial Administration GPA 3.9/4.0
Krannert School of Management, Purdue University, West Lafayette, IN
2004-2005
. Accelerated one-year MBA program; Krannert Scholar, Top 5% in class;
Beta Gamma Sigma Honor Member
Ph.D. in Chemistry GPA 3.8/4.0
Master in Computer Science GPA 4.0/4.0
University of Missouri-Rolla, Rolla, MO 1998-2002
. Teaching Assistant, taught Instrumental Methods of Chemical Analysis
class
Bachelor of Engineering in Packaging Engineering GPA 3.9/4.0
Jilin University, Changchun, China 1992-1996
. Elected as Class President from sophomore to senior year; Highest GPA
in class;
ANALYTICAL INSTRUMENTS SKILLS
MS (GC, LC, ICP), HPLC/UPLC, GC, FT-IR, UV/Vis, TGA/DSC, IC, GPC,
SFC, ICP-OES