Quality Control Assurance
Resume:
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, laboratory automation, electronic lab notebook, 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
Mathlab JAVA PERL HTML/XML S-PLUS, R, JMP
VISUAL BASIC 4.0-6.0 CRYSTAL REPORTS
6-11 DESIGNER 2000 ORACLE/
CLINICAL Labware LIMS/ LIMS Basic
Work Experience:
Labware Consulting.2006 - present
• Mar2011-Dec2011 Chugai Pharmaceuticals Implementation, testing and validation of LIMS system.
• Aug2010-Dec2010 Merck Research Lab. Upgrade LIMS Responsible for Lot Management and sample management. LIMS Basic code development and testing. Crystal Reports.
• Feb2009-Jun2010 Pfizer/Wyeth Global Implementation Team. Quality Lab, Lean Lab, SPC charting. LabWare LIMS v5-v6 upgrade project - Authoring of Detail Design Specifications, Technical Design Specification, Unit Test Scripts for development of Core Laboratory Design and implementation of Facilitated Data Review (FDR) functionality within the LIMS. The FDR reduced cycle time for review of batches by collecting all objects associated with a batch in the LIMS (Samples, Tests, Results, Instruments, standard reagents, investigations, etc) into one review screen.
• Aug2008-Jan2009 Merck & Co. Software configuration for Clinical trials, Phase II and III using CDISC, SDTM, ODM combining SAS9.1 and LIMS. Interfaced LIMS and SAS so that LIMS was the trial database and SAS did the statistical analysis of the trial. Created CDISC, SDTM tables in LIMS and SAS.
• Jan2008-Jul2008 Mayo Clinic Rochester, MN. Clinical trial implementation for Phase III studies. Interfaced LIMS and SAS9.0. Code to create tables, listings and figures and reports in SAS.
• Oct2006-Dec2007 Wyeth Pharmaceuticals. Rouses Point NY and Brandon, MB Canada. LIMS development for lab testing of drugs involved in hormone replacement therapy. Interfacing to Waters chromatography system, drug dissolution, environmental monitoring and reporting. Developed and tested LIMS BASIC routines.
• Apr2005-Sep2006 Wyeth Pharmaceuticals. Andover MA. LIMS in Raw Material testing. Creation of static data, lot management and product specifications.
• Jan2006-Mar2006 Schering Plough Unit testing of LIMS Basic for environmental monitoring and stability.
• Experience with Electronic Lab Notebook, Clinical, Biobank and Public Health implementation.
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 used in Phase I trials.
• 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. Developed expertise in Oracle Forms and Oracle Reports and Crystal Reports.
• nDesigned, 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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