NITIN KUMAR PATEL

** ***** ******, ***#*

Jersey City, NJ 07306

nitinpatel1288@gmailcom; Phone: 201-***-****

OBJECTIVE:

Seeking an exciting opportunity in biopharmaceutical research and

development that leverages my strong academic, laboratory, and problem-

solving skills towards formulation development

EDUCATION:

Masters in Pharmaceutics (Industrial Pharmacy), Long Island University,

Brooklyn, NY 01/12-12/13

Bachelors in Pharmacy, Gyan Vihar School of Pharmacy, Jaipur, India

08/05-09/09

Professional Credentials: Registered Pharmacist, Rajasthan Pharmacy

Council, India 2009

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WORK EXPERIENCE:

Quality Assurance Associate, Summit Rx Inc., Jersey City, NJ

06/14-Present

. Reporting the findings to applicable departmental management;

following-up to ensure adequate completion of corrective actions

. Working closely with contract manufacturing, testing and packaging

facilities to resolve quality issues; making sure Corrective and

Preventive Actions (CAPAs) are identified and implemented effectively

. Preparing documents in compliance with Current Good Manufacturing

Practice (cGMP), protocols, Standard Operation Procedures (SOPs) and

other regulations/guidelines

. Updating senior management about audit findings and corrective actions

. Keeping QA Management is up-to-date on audit findings and corrective

actions

Assistant Production Manager, Gujarat Industrial Chemical Ltd, Gujarat,

India 02/10-11/11

. Managed tasks to ensure production area is under control. Activities

included:

o Maintenance of temperature and sanitization

o Track record of raw materials and other inventories

o Instrument calibration: viscometer, weight balance, pH meter,

conductivity controller on process tanks

. Practiced current Good Manufacturing Practices (cGMP) and FDA

regulations in the production area

. Processed the data; documented it in batch records; prepared SOPS and

reports

. Involved in procurement of manufacturing instruments and materials

Intern, Borocaps Pharmaceuticals, Jaipur, India

09/08-11/08

. Participated in a team for formulation development, optimization and

process development of oral solids (tablets and capsules) and liquid

dosage forms (syrups)

. Operated process equipments and analytical instruments for tablet

manufacturing and studying their properties during pre-formulation

studies. Equipments include:

o Fluid Bed Dryer, Tablet Press, Homogenizer, Blender, HPLC, UV-

vis

. Studied the release profile of Active Pharmaceutical Ingredient (API)

through dissolution tests

. Involved in analyzing various manufacturing and packaging processes.

ACADEMIC PROJECTS:

Research Project, Long Island University

09/13-12/13

. Performed method development and validation of diphenhydramine HCl

using WATERS HPLC (autosampler)

. Determined the unknown concentration of drug by using standard

calibration curve

. Analyzed the data using Totalchrom and Winnolin software.

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Research Project, Long Island University

02/13-05/13

. Studied the effect of particle size on bio-availability of drugs.

. Performed dissolution studies using USP1 and USP2 apparatus.

. Result: Observed the increase in bio-availability with increase in

surface area of the particle; bio-availability increase with increase

in absorption.

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