Patel Vishakha
Analytical Chemist
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About
To obtain a Chemist position to serve at my best skills and knowledge where my education and experience are well utilized. Over Seven years of experience as an Analytical Chemist in Pharmaceutical drug substance and drug products.
Experience
Associate Research Scientist - Catalent Pharma Solution - Somerset, NJ, USA
(2006-10 - 2009-06)
- Analyzing Finished Product testing Dissolution, Assay & Impurity Assay using HPLC
- Analysis of Clinical & Experimental batches
- Conducting Investigations for product quality
Associate Research Scientist - Bristol-Myers Squibb - New Brunswick, NJ, USA
(2006-03 - 2006-07)
- Analysis impurity, assay, content uniformity for Drug Product, impurity and assay for API
- Performing tech-transfer for Drug Product, and basic knowledge for IND & NDA validation, and also familiar with PDLIMS & PDPM
- Troubleshooting of HPLC, FTIR-Spectrophotometer, UV-VIS spectrometer, Dissolution Apparatus
- Following under SOP's, cGMPs and FDA regulation
Analytical Chemist II - Stride Pharmaceutical - Somerset, NJ 08873
(2005-11 - 2006-03)
- Responsible for testing of all finish product (tablets and capsules), R&D samples, Stability, product process validation samples and also media preparation as per USP and in-house methodologies using various analytical techniques with good documentation
- Performing purity and assay analysis on Raw materials, Blends and Finished products using wet chemistry
- Responsible for calibration HPLC, Dissolution, UV Spectrophotometer, IR Spectrophotometer, pH meters, Melting point, Analytical balances, Moistures, Hardness, Friability, Tap density, and Sieve analysis
Analytical Chemist II - Pharmaceutical Formulation Inc - Edison, NJ 08820
(2003-06 - 2005-11)
- Responsible for testing of all finish product (tablets and capsules), R&D samples, Stability, product process validation samples and also media preparation as per USP and in-house methodologies using various analytical techniques with good documentation
- Performing purity and assay analysis on Raw materials, Blends and Finished products using wet chemistry
- Responsible for calibration HPLC, Dissolution, UV Spectrophotometer, IR Spectrophotometer, pH meters, Melting point, Analytical balances, Moistures, Hardness, Friability, Tap density, and Sieve analysis
- Performs method validation for HPLC methods, Stability testing, Process and cleaning validation analysis following under SOP's, cGMPs and FDA regulation
Education
Bachelor of Science - Chemistry - Gujarat University (2002-04)
High School Diploma - Chemistry and Math (1999-03)
