Quality Control Assurance

N. Raghavan

**** **** ******

Bridgeport, CT ****4

**********@*****.*** Cell: 203-***-****

PROFILE

A Scientific programmer with over twenty years of experience utilizing

multiple languages and platforms. A strong background in science and

research as well as a PhD in physical chemistry. Proficient and comfortable

in the operation within any scientific laboratory environment.

Demonstrated analytical and problem solving skills in the following

disciplines: scientific information processing, laboratory information

management systems, clinical trials data management, bioinformatics,

cheminformatics, molecular modeling, applied statistics and mathematics.

Over fifteen years of Laboratory Information Management skills in pre-

clinical, clinical, research and development, quality control and

manufacturing implementations.

Programming Expertise:

C ORACLE 7.x-11 VAX/VMS PL/SQL

SAS SAS/BASE SAS/STAT SAS/GRAPH SAS/QC

JAVA PERL HTML/XML S-PLUS

VISUAL BASIC CRYSTAL DESIGNER 2000 ORACLE/ Labware

4.0-6.0 REPORTS CLINICAL LIMS/ LIMS

Basic

Bioinformatics Experience:

Used PIR databases from NIH and programs to work on the structure

predictions of Growth factors, Platelet factors, Calcium binding proteins

by homology modeling. Knowledge of programs used in sequence comparison and

protein secondary structure prediction. Molecular Modeling in Drug Design.

Structure-Activity Relations and Drug Design. Energy Calculations using

AMBER and Discover. Computer Graphics Software in Molecular Modeling.

Work Experience:

Labware Consulting.2006 - present Independent consultant for global Labware

LIMS implementation at

. Merck & Co. Summit, NJ. Software configuration for Research Labs.

. Implementation of a Clinical Trials Management System (CTMS) for phase

II and Phase III Clinical Trials using CDISC, SDTM, ODM interfaced to

LIMS

. Pfizer/Wyeth Global Implementation Team. Quality Lab, Lean Lab, SPC

charting, EM, Stability. Made review process easier with facilitated

data review.

. Schering Plough Unit testing of LIMS Basic

Tri-Com Consulting. Pfizer Global Research & Development Informatics 2004

- 2005

. Consultant, Technical Lead and LIMS Administrator to PGRDi for the

implementation of LabWare LIMS at the new Pfizer New Haven Clinical

Research Unit. The Research Unit conducts Phase I clinical trials and

biomarker studies for Pfizer. Interfacing with Clinical Instruments

and instruments in Biomarker Research and Development.

. As technical lead ensured that IT processes and business processes

were aligned by maitaining control over requirements gathering.

. As LIMS Admin and developer, developed Crystal Reports, LIMS Basic

routines and Oracle SQL queries for all aspects of the project.

Agreeya Solutions. 2003-2004. Consultant to Ngrid Utilities.

. Interfacing LabWare LIMS to analytical instruments such as HPLC and

GC for the analysis of transformer degradation and preemptive action.

Developed Crystal Reports, LIMS Basic routines and SQL queries for

daily operations.

Bayer Diagnostics. Tarrytown NY Consultant 1993- 2003

. Developed, tested and validated SAS software for Quality Assurance

and testing of Immunodiagnostic instruments and reagents. SAS

modules used were SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/AF and

SAS/Macros Instruments and reagents were checked for statistical

process control using SAS/QC. Interacted with manufacturing sites in

Puerto Rico and Dublin on this project. The project demonstrated the

reliability and quality of Bayer instruments.

. Developed, tested and validated LIMS programs to maintain data

acquisition and laboratory data from instruments. Software used in

the development of assays for immunodiagnostics on Bayer line of

instruments and reagent products. Investigated use of Labware LIMS

amd SQL-LIMS for this application. Developed LIMS interfaces with

EZChrom Elite and other instruments. Developed expertise in Oracle

Forms and Oracle Reports and Crystal Reports.

Designed, developed, tested and validated Clinical Trials database in MS-

ACCESS including creation of CRF screens and submission reports.

Resulted in the approval of 6 assays for early detection of breast and

prostate cancer by FDA.

. Implemented 21CFR11 guidelines into Bayer's electronic records of

equipment calibration.

Assisted in successful audits and ISO-9002 certification.

. Mentored four junior non-technical programmers in scientific software

requirements, design, testing and validation improving the efficiency

of the department.

Self Employed Technical Consultant 1991- 1993

Consultant to Roche Biomedical and Therion Corporation Designed and

developed DNA fingerprinting software. Software forms the basis for DNA-

paternity analysis by Roche and lab animal quality control by Therion

. Designed and developed Software for analysis of 2D-gels and

Laboratory Information Systems (LIMS) used in DNA-paternity testing.

Lifecodes Corporation. Valhalla NY Data Specialist 1986 -1991

. Led this biotechnology subsidary of Quantum Chemical in information

technology.

. Supervised and mentored two junior programmers resulting in

efficiency improvements.

. Designed and developed programs for DNA based identification of

forensic samples and paternity samples and digitizing of

autoradiographs. Implemented the statistical treatment of data

involved in DNA fingerprinting. Contributed to the success of the

company

. Designed and developed LIMS software for sample tracking of forensic

samples through the laboratory. Contributed to the success of the

company.

Brookhaven National Laboratory. Upton NY 1980 - 1986

Senior Research Scientist. Biology Department.

. Researched protein structure and function, molecular modeling of

proteins. Successfully investigated the use of neutron diffraction as

a technique for structure analysis. Investigated solvent structure

and cavities in proteins as models for rational drug design.

. Successfully computed Energy Calculations using AMBER and BIOSYM.

Developed familiarity in protein and nucleic acid databases like NIH

and Genebank. These databases and software are the basis of

bioinformatics.

. Implemented Computer graphics software for Molecular Modeling. Used

by other research scientists.

Michigan State University. East Lansing MI 1976 - 1979

Research Associate. Chemistry Department

. Mentored and guided four graduate students in their research

activities.

. Trained in protein crystallography and protein structure and

function.

. Researched protein structure and function and molecular modeling.

Investigated the structure of chymotrypsin and protease inhibitors.

This is useful in drug design.

Education:

University of Texas at Austin. Austin Texas 1970-1974

Ph.D in Physical Chemistry.

. Molecular Orbital Methods, statistical thermodynamics, X-ray

diffraction, and quantum chemistry, Courses in computer

programming

Indian Institute of Technology, Bombay, India 1968-1970

M.Sc. in Chemistry.

. Solid State Chemistry, Analytical Instrumentation, Numerical

Analysis, Organic, Inorganic and Physical Chemistry.

Other Education (Seminars and Non-Credit Courses etc):

. Trained in Oracle Developer 2000, Designer 2000 and Java database

programming.

. Trained in PE SQL-LIMS, PE SQL/QC, PE SQL/STABILITY and Fluke Met-

Track

. Trained in LabWare LIMS Administration I & II

. Trained in Crystal Reports.

. Trained in SAS data step by SAS Institute.

. Trained in ORACLE/CLINICAL by Oracle Corporation.

. Course in Project Management by American Management Institute.

. Course in CMM (Capacity Maturity Model)

. Non-credit courses in Biochemistry, advanced computer programming

using Pascal, C and Unix. Simplex methods in experimental design and

Pattern Recognition. Interest in Artificial Intelligence Programming

and Expert systems.

Awards & Recognition:

. Bayer Special Recognition award for Customer Focus 2000

. Bayer Special Recognition award for Customer Focus 2001

. Bayer Special Recognition award for Quality 2002

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