Dirgesh Patel

** ****** **.

Piscataway, NJ *****

601-***-****

acvx5v@r.postjobfree.com

Objective

To obtain a responsible position with company an Analytical Chemist where my experience, accomplishments, and proficiency will allow me the opportunity for growth.

Work Experience

Cliantha Research ltd. India,

Research Associate in Bioanalytical -- January 2013 - August 2014

•Performed BA/BE studies of API in human biological matrices using LC/MS and HPLC in a GLP regulated laboratory environment

•Performed Method Developement and validation of API using LC/MS/MS and HPLC techniques following FDA guidelines.

•Experienced with operation, troubleshooting, and maintenance of Applied Biosystem Sciex Triple Quadrupole LC/MS/MS with Agilent and Shimadzu HPLCs.

•Review of Complete Analytical Results.

•Evaluation of Pilot study results for the initiation of Pivotal study.

•Competent in conducting routine sample analysis for drug and its metabolites.

•Carrying out routine calibration of HPLC, LC/MS (API 4000), Analytical balance and micro balance, micropipettes, pH Meter, Evaporator etc.

•Documentation and review of Analytical Procedure Sheet.

•Preparation of Training materials and Conduct of in-house Training.

•Manages Sample inventory and Storage.

•Day to day monitoring and maintenance of GLP in laboratory.

Zydus Research center, Cadila Healthcare ltd. India,

Junior Research Associate in DMPK -- January 2012 - January 2013

•Qualitative and quantitative analysis of biologically active compounds in complex biological matrices (in vitro & in vivo studies) using LC/MS and HPLC support of high-throughput DMPK (drug metabolism and pharmacokinetics) and ADMET (absorption, distribution, metabolism, excretion, and toxicity) studies.

•Gained experience in the operation, calibration and maintenance of laboratory equipment and analytical instrumentation within environmental laboratory, including GC, GC/MS, UV, FT-IR, and Dissolution systems.

•Performed drug and their metabolites and plasma stability study.

•Method development for various NCEs projects that include evaluation and optimization of method as well as processing method to extract drug and its metabolites from animal plasma/serum using different sample preparation.

•Performed calculations and preparation of required solutions for studies.

•Prepared SOPs and maintained the logbooks with accuracy.

•Review of standard operating procedures (SOPs) and related laboratory procedures and activities.

•Plan and manage scheduled preventative maintenance.

Mediwin Pharmaceuticals, India,

Intern Trainee -- November 2011 - December 2011

•Trained on Tablet, Capsule and Liquid Oral manufacturing and packaging as well as in Quality Control laboratory.

•Participated in process validation of Tablet, Capsule and Liquid Oral.

•To check and ensure in process parameters during manufacturing and packing.

•Trained on SOPs complies with cGMPs.

Academic Qualification

•Master of Science in computer information system from American college of commerce and technology, Virginia. Mar 2016.

•Master of Pharmacy in Quality Assurance from G.H.B College of Pharmacy, Gujarat Technical University, Ahmedabad, Gujarat, India. Jun 2014

Performed project on “Development and validation of analytical methods for simultaneous estimation of Propoxyphene napsylate and Acetaminophen in tablet” under guidance of Dr. Somayaranjan Mohapatra at G.H.B College of Pharmacy, Godhra. Gujarat Technical University, Ahmedabad.

•Bachelor of Pharmacy from Maratha Mandal’s College of Pharmacy, Rajiv Gandhi University, Bangalore, India. Dec 2011

Other Technical Skills

•Experienced with a variety of sample preparation techniques and methods such as LLE, SLE, protein precipitation, and SPE and common pharmacokinetic modelling and distribution methods.

•Extensive knowledge of pharmacokinetics studies and BA/BE studies.

•Experienced in tissue extraction and analysis.

•Tandem Mass Spectrometry

Sciex API 5500, 4000, 3200, 3000 and Waters

HPLC and UPLC

Agilent and Shimadzu

Software: Analyst.., Chemstation, Masslynk

•Documentation skill as per GLP.

Contact this candidate