Samir Patel

** ********* **** *-* Apt, East Windsor, NJ 08512 I Cell:760-***-**** I E-Mail: ac0fuv@r.postjobfree.com

Professional Summary:

Looking for challenging and rewarding position where experience, educational background, and interpersonal skills will be effectively utilized. Industrials experience includes Process development and analytical analysis on a variety of drug substance and drug products in a cGMP/GLP environment. Results oriented worker with calibration, metrology and quality control experience at major pharmaceutical.

Skills:

●Knowledge of Waters HPLC with UV,RID and PDA,water UPLC with PDA, Shimadzu Lc-2010,Agilent 1100.1200.1260 with VWD,MWD,Distek Dissolution 2500,6100,7100,Autosampler,Shimadzu UV-1800,Metrohm KF Titration,Vankel Disintegration Tester,Thermo fisher FTIR.

●Servicing for HPLC, UPLC, GC, UV, TOC, Milli-Q water system and Dissolution unit.

●Multi Tasking, fast learner, Team player.

●CGMP/GLP, ICH, USFDA environment.

●Process development and scale-up.

●Microsoft office, ChemDraw, Sci-finder,ChemSketch, LIMS, Empower, ThermoOmnic,DataPro,

Lc Solution, Chemical inventory etc.

Accomplishment:

I have successfully completed Advance Chromatographic training at Advance Analytical Research and Training institute in Ahmedabad, India.

Work History:

Associate Chemist 11/2014 to Present

Aurolife Pharma LLC, Dayton NJ 08810.

●Analysis of Finished product,In process,Stability Samples of Tablets,Capsules,Powder by following SOP,USP Method and In House Test Method Using analytical instrument.

●Analysis of Process Validation and Method Validation Samples.

●Performed Analysis of Assay,Content Uniformity,Dissolution,Dissolution Profile,Identification Test,Cleaning Verification/Validation By HPLC,UPLC and UV etc

●Dealing With Uses and Destruction of Controlled Substance as per DEA requirement.

●Performed Bulk Density,Tapped Density,Particle Size Distribution by Retsch Sieving Machine.

●Analysed Rinse Samples by TOC analyser.

●Dealing With Uses and Destruction of Controlled Substance as per DEA requirement.

●Used Empower-3 Software for Operation and Data Evaluation.Used LIMS to Submit Analysed Result.

●Analysed and trouble shoot Wide range of Technical problems that caused delays significantly increasing daily outputs.

●Determined Analysis Priorities,Organize Workload,Completed Analysis in Timely Manner.

●Maintained Column Records and instrument spare parts Inventory.

●Performed Calibration of Laboratory Equipments including Balance,pH meter,Karl Fischer Titrator,HPC,UPLC,Dissolution unit,Disintegration,UV,FTIR,Melting Point,System suitability for GE TOC analyzer.

●Responsible for scheduling and carrying out calibration, Preventative maintenance and repairs of laboratory equipment in the Quality control dept. and R&D.

●Maintain up to date calibration records, work orders database, Service report, Purchase order and Invoices.

Research Associate, 06/2011 to 12/2012

Alembic Research Center, Vadodara, Gujarat, India.

●Handle various reaction like Multi step Synthesis, Reduction, Oxidation reaction, air sensitive reaction in lab as well as pilot plant and kilo lab scale

●Performed routine analytical analysis of API, Raw material, Stability samples using In House method following STPs, GLP/cGMP and FDA regulations.

●Testing a Residual solvent by GC.

Research Scientist-II, 05/2010 To 06/2011

Torrent Research Center, Ahmadabad, Gujarat, India.

●Literature search for various process routes of APIs, intermediates to yield cheaper, feasible, environment friendly, less time consuming, commercially viable with the quality as per the international market requirement.

●Experience in area of crystallization, separations, purifications & Identification of impurities, API and Raw material using various analytical tools.

●Performed routine analytical analysis of raw material, API and R&D samples and in-process samples according to department procedures and specification.

●Analysis of raw materials for release purpose by HPLC, GC and wet chemistry.

Research Officer, 09/2008 To 04/2010

Unimark Remedies Ltd, Ahmadabad, Gujarat, India.

●Development of non-infringing technology of API for regulated & non-regulated market.

●Development of purification process for API and their Intermediate.

●API, Impurity and raw material characterized by Spectroscopic and Chromatographic technique.

●Performed routine analytical analysis of raw material, API, Stability and R&D samples and in-process samples according to department procedures and specification.

●Documentation activities like, Preparation of SOPs, Certificate of Analysis and review lab notebook to ensure accurate documentation.

●Provide general laboratory support such as routine instrument cleaning/ preventative maintenance/ calibration, sample receiving, chemical inventory, document filing etc.

Sr Chemist, 10/2006 To 09/2008

Zydus Cadila Healthcare Ltd, Ankleshwar, Gujarat, India.

●Development of cost effective, high yielding process for API and their raw materials.

●Responsible for demonstration/technical transfer of lab process to kilo lab and pilot plant.

●Performed routine analysis of raw material, In-process, and API according to approved department procedures and specification By HPLC and TLC Method.

●Solved process troubleshooting, which arise during production and Lab Process.

●Dispose off the hazardous and non-hazardous waste according to the SOPs.

Education:

Master of Science: Organic Chemistry (M.S).

Veer Narmad South Gujarat University, Surat, Gujarat, India

GPA: 3.2 (Evaluate by WES).

Bachelor of Science: Chemistry (B.S).

Veer Narmad South Gujarat University, Surat, Gujarat, India

GPA: 2.8 (Evaluate by WES).

Additional Information:

I am US citizen and legally eligible to work in the USA without any sponsor.

Reference:

Available upon request.

Contact this candidate