NIRAV PATEL

** ****** **, *****, **-*****

Home: 631-***-****

Mobile: 201-***-****

E-mail: fwrfs5@r.postjobfree.com

Career Summary

To become an integral part of globalize pharmaceutical industry. As well as seeking Research Scientist / Scientist position to utilize knowledge and to gain experience in pharmaceutical industry. My skills and understanding of the analytical techniques will definitely contribute towards the development of quality of pharmaceutical products which will be more efficient, safe, patient friendly and easy to use.

Speciality

Understanding of operation and interpretation of Analytical instruments like GC (Perkin Elmer with Total Chrom software), HPLC’s (Waters) with RI Detector, Fluorescence Detector, UV and PDA Detector, UPLC’s (ACQUITY) along with software Empower-2, UV-VIS (Agilent, Perkin Elmer), FT-IR (Perkin Elmer), Particle Analyzer (wet and Dry) (Malvern), Dissolution Apparatus I and II ( Distek, Sotax), Dissolution Apparatus USP Type III (Varian), API 3000 ( LC MS ) with analyst software.

Education

M.S Industrial Pharmacy January 2006-May 2008

Long Island University, Brooklyn, NY

Bachelor of Pharmacy January 2001-December 2004

Rajiv Gandhi University, Bangalore, India

Work Experience

Scientist III April 2011-Current

Amneal pharmaceuticals, Brookhaven, NY

• Analysis of pharmaceutical Drug Products/Substances for its quality using modern analytical techniques and instruments like High performance Liquid Chromatography(HPLC) ,UPLC, Gas Chromatography (Perkin Elmer), UV (Agilent , Perkin Elmer), Dissolution Apparatus (USP- I, II),Infra Red Spectroscopy(IR), Particle Analyzer (Malvern), API 3000 (LC-MS), XRD (Panalytical), DSC and TGA (TA Instruments).

• Method validation/verification protocol and report preparation in ‘eCTD’ filling with ISIWRITER format for regulatory purpose.

• Development and validation of an analytical method for test of Residual solvents, Assay, Dissolution & Related substances according to ICH Guidelines and also performed API characterization.

• Reviewing test results for soundness, accuracy and GLP compliance.

• Perform stability study of Drug Products, for US Market ANDA (Abbreviated New Drug Application) to submission at FDA and preparing reports for FDA submission.

• Prepare ANDA Filling Drug substance documents like Characterization, API Justification, Reference standard, Batch analysis, Quality overall summery (QOS) etc using ‘eCTD’ filling with ISIWRITER format for regulatory purpose.

Scientist II December 2008-March 2011

Amneal pharmaceuticals, Brookhaven, NY

• Analysis for Drug substance, Container and closer as per USP

• Calibration, Maintenance of analytical instruments used in laboratory as per cGMP standard. Technology transfer from R&D to manufacturing quality control department.

• Trouble shooting of HPLC, UPLC, GC and other Analytical instruments.

Chemist December 2004-December 2005

Aquila lab, Nadiad, India

• Carried out various raw materials testing as per EP, USP.

• Analysis of pharmaceutical Drug Substances for its quality using modern analytical techniques and instruments like High performance Liquid Chromatography, IR, Melting point, UV.

• Carried out Heavy metals, Arsenic, Melting range, Disintegration, Assay, Related substance, Residue on ignition, LOD, Karl fisher and Various wet chemistry testing etc.

Internship Program November 2003-December 2003

Elysium Phama. Ltd, Baroda, India April 2004-July 2004

• Involved in the supervision of manufacturing and packaging of tablets.

• Responsible as a team for the various test carried out in quality control department.

• Getting basic knowledge of HPLC, UPLC, GC, IR, UV, and FLOUREMETER.

Awards and Recognitions

Graduate Assistantship September 2007-December 2007 Long Island University, Brooklyn, NY

• Supervised the Residential Computing Assistants.

• Troubleshot technical problems that students encountered.

• Communicated solution to aid students in computer use.

Graduate Teacher’s Assistantship September 2007-December 2007

Long Island University, Brooklyn, NY

• Created PowerPoint presentations based on professor’s notes and class materials.

• Researched current management issues and updated packets.

Scholarly Work and Presentation

• Presentation on the “Targeted Drug Delivery System” January 2006-May 2006

Includes the nanoparticles, liposomes, prodrugs, resealed erythrocytes and antibody-targeted system

• Attended a training program on the topic of cGMP. Jun 2004-October 2004

• Bio assay of Histamine using Rat Ileum by Interpolation Jun 2004-October 2004

And three points methods.

Computer Skills

Application software : MS Word, Excel, Power Point

Operating software : Windows 95/98/2000/NT/XP/Vista/2007

Reference available on request.

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