Technical Support Quality Control

OBJECTIVE

To explore new opportunities to contribute exceptional talents in research, quality assurance and regulatory compliance toward supporting the employer in achieving objectives

EDUCATION

Middlesex County College, Edison, New Jersey

Project Management Certificate Course, 2008

University of California, San Diego, California

Online Course :Regulatory Compliance for Drugs and Biologics, 2007

Ohio University, Athens, Ohio

M.S. Analytical Chemistry, 1986 - 1989

Thesis: “The Microarc as an element selective detector for the Gas Chromatograph”

University of Madras, Madras, India

B.S. Chemistry, 1974 - 1978

EXPERIENCE

Chromocell Corporation, North Brunswick, New Jersey

Panelist September 2012-Present (Part-time position)

Taste testing of lemon-lime beverages.

Centocor Inc. (A Johnson & Johnson Company), Raritan, New Jersey

Senior Scientist - Quality Control Technical Support, 1997 - 2006

Trouble shooting and optimization of HPLC methods; training of personnel on data acquisition software and test methods; writing of SOP’s, STP’s and technical documents; review of data from contract and QC labs; use of LIMS for entering test results and also tracking non-conformance events using a Global Events Tracking System; execution of transfer protocols for test methods from other companies; provide technical support and problem solving for quality control laboratories; familiar with sialic acid, monosaccharide quantitation in glycoproteins and N-Linked Oligosaccharide Mapping using Dionex HPAEC-PAD.

Organon Inc., West Orange, New Jersey

Scientist, 1993- 1997

HPLC methods development; trouble shooting methods; writing the analytical section of CMC for IND & NDA submissions; recipient of the unit award for successful completion of projects on time; successfully developed a capillary GC method for quantification of residual solvents in drug substance; well versed in the use of computers for data acquisition, analysis and word processing; trained personnel on different analytical instrumentation such as HPLC, UV-VIS Spectrophotometer, TLC etc.

Parke Davis Research, Morris Plains, New Jersey

Associate Scientist, 1990 - 1993

HPLC analyses of raw materials and finished products; assay of incoming raw materials and initial samples; developed an ID test for a solid dosage formulation using FT-IR; validation of HPLC methods - method validation for IND and NDA submissions; method development - developed an HPLC method for injectables; dissolution studies- dissolution work on capsules and tablets; stability testing of different dosage forms such as capsules, tablets and parenterals; data interpretation and report writing

Merck & Company, Rahway, New Jersey

Process Safety Laboratory Chemist – Temporary Assignment, 1989

Thermal Analysis (DSC/DTA, TGA testing) of process intermediates in pharmaceutical synthesis and final products, interpretation of data and report writing

Department of Chemistry, Ohio University, Athens, Ohio

Graduate Associate, 1986 - 1988

Instruction and supervision of undergraduate laboratories; comprehensive responsibilities from pre-lab lectures to grading lab projects; research work on the feasibility of using computer controlled microarc as an element selective detector for the GC

STATUS

U.S. Citizen

REFERENCES

Available upon request.

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