Chemist Chemistry

Amit Patel

* **** *****, ******, **-***** adihg5@r.postjobfree.com Cell:732-***-**** Home:732-***-****

PROFESSIONAL EXPERIENCE

Lupin Somerset, Somerset NJ Mar. 2016-Present

Senior Scientist

Analytical method development and method validation for the drug products and drug substances

Method verification of compendial & non-compendial methods

Method development and analytical method validation for physical tests for Nasal Spray like

SCU,Spray pattern,Plume Geometry,DSD.

Employed techniques of analysis involving UPLC, HPLC, GC, UV & KF, Particle size analyzer, Malvern Spraytec, Sprayview, ADSA, PAWS, HAM instrument etc

Prepared validation protocols, reports, standard test procedure & specifications

Provided analytical support to product development department

Worked and responds to FDA deficiencies

Perform technology transfer of analytical procedures between laboratories

Ohm Laboratories Inc, New Brunswick NJ Aug. 2012- Feb. 2016

Senior Chemist

Method development & method validation of solid dosage, oral suspensions, & API’s

Method optimization & verification of client methods

Performed analytical tests: assay, related substances, BU, CU, cleaning verification using HPLC, GC, TLC, UV – Vis

Testing of solid dosage e.g. dissolution, water content, bulk density, tapped density, particle size distribution, identification by IR-spectroscopy etc.

Performed the stability studies & hold time study, prepared compilation report & COA’s.

Worked on extended release drug product, with an auto sampler, performed multi-media dissolution and dosage dumping analysis, and stratified sample analysis

Assisted in investigations of OOT, OOS results & deviations

Handled the project from exhibit batch to stability study, provided the data for ANDA submission

Handled controlled substances schedule II, III & schedule IV

Aurobindo Pharma, Dayton NJ June 2011- Aug. 2012

AR&D Chemist

Method Development for the solid dosage drug product and performed subsequent analytical method validations and method transfers to the QC department

Developed and performed analytical tests methods: Assay, Related Substances, BU, CU, cleaning verification using HPLC, TLC, TOC, UV – Visible spectroscopy

Provided analytical support to Product Development department

Handled the controlled substances schedule II, III & schedule IV

Apicore LLC, Somerset, NJ Apr. 2007 – June 2011

Research Chemist

Synthesis of APIs through infringing as well as non-infringing routes

Process research, process optimization, and scale up of API’s

Performed impurity synthesis, isolation, & characterization

Wrote technical reports, SOP’s, and validation batch protocols

Process validation and process transfer to manufacturing department of an API & intermediates

Filled up and maintained Master Batch Records

Managed project timelines

Worked on carbohydrate molecules and highly potent active ingredients

Sidmak Laboratories Pvt. Ltd, India Jun. 2005 – Jun. 2006

Analytical Chemist

Developed analytical methods for the analysis of solid dosage forms and validations

Conducted chemical analysis on in process materials and finished products using specialized instruments and apparatus such as HPLC, Ultra-Violet spectrometer, Dissolution apparatus

Performed calibration of critical lab instrument like HPLC, UV – Visible Spectrophotometer & Dissolution Apparatus (USP I & II)

Calibrated pH meter, Conductivity meter, Balance, Disintegration test machine, Friability apparatus

Experienced in identification and troubleshooting of analytical and minor instrumental problems

Performed the stability studies of various dosage forms of finished product

EDUCATION

Doctor of Philosophy (Chemistry) Aug. 2004 – Jan. 2007

Veer Narmad South Gujarat University, Gujarat, India

Master of Philosophy (Chemistry) Aug. 2002 – Jul. 2004

Veer Narmad South Gujarat University, Gujarat, India

Master of Science (Organic Chemistry) Jul. 1998 – May. 2000

Veer Narmad South Gujarat University, Gujarat, India

Bachelor of Science (Chemistry) Jun. 1995 – May. 1998

B K M Science College Gujarat, India

PUBLICATIONS

1. “Synthesis and Characterization of Reactive Dyes and Their Application on Various Fibres”

A. L. Patel, H. S. Patel & K. C. Patel*

Oriental Journal of Chemistry, Vol. 22(3) 559-564, 2006

2.“Synthesis and Characterization and Application of Hot Brand Reactive Dyes on Various Fibres”

A. L. Patel, B.M.Patel, N.B.Patel & K. C. Patel*

Asian Journal of Chemistry, Vol.19, No. 1(2007), 67-76

3.“Reactive dyes based on 4,4’-methylene bis-(2,3-dichloro aniline): Their synthesis, characterization and application”.

Amit L. Patel, Divyesh R. Patel, Lina A. Patel, Keshav C. Patel*

Colourage, 57(4), 2010, 72-76.

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