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Quality Assurance Training

Location:
2120
Posted:
March 09, 2010

Contact this candidate

Resume:

HIRAL PATEL Phone: 678-***-****

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

Boston, MA 02120.

Email: ***********@*****.**.**

Objective

To obtain Research Associate position.

Summary

A self-motivated and competent fresh graduate with solid academic background. Adept in analytical

techniques including Size exclusion chromatography, HPLC, SDS PAGE, imaging Capillary electrophoresis, UV-

visible spectroscopy, Wet chemistry analysis, flow cytometry and solid phase cytometry. Worked in both GMP

and GLP laboratories. Proficient at molecular biology laboratory techniques including DNA extraction and

purification, mRNA purification, recombinant DNA technology, qRT-PCR, end point PCR, gel-electrophoresis,

siRNA and western blotting.

Education

MS, Pharmaceutical Sciences, Major: Pharmacology, GPA: 3.81 (expected) Aug 2009

Northeastern University, Boston, MA

Relevant Course Work: Molecular cell biology, Biochemistry, Pharmacology I, Receptor Pharmacology, Human

physiology, Concepts of pharmaceutical sciences, Drug design and drug evaluation and Experimental design

and biometrics.

BS, Pharmacy, QPA: 3.8 (Awarded) May 2007

Sardar Patel University, Vidhyanagar, INDIA

Relevant course work: Microbiology, Pharmacology I, II, Clinical pharmacology, Pharmaceutics, Dosage form

designing, Pharmaceutical engineering, Pharmaceutical chemistry and Pharmacognosy.

Professional work experience

Internship, Pfizer Global Research & Development, St.Louis, MO. May 2008 - Aug 2008

Project: Preliminary screening of preservatives for a monoclonal antibody formulation. Performed stability

studies and antimicrobial effectiveness testing.

Worked in GLP and GMP labs. Handled SOPs and prepared protocols.

Performed various analytical techniques including Size exclusion chromatography, HPLC, SDS PAGE,

imaging Capillary electrophoresis, UV-visible spectroscopy, ultracentrifugation, pH metry and

Appearance on monoclonal antibody formulation.

Obtained training with Chemstation, Empower, EZ Chrome, Quantity one and Cary winUV.

Worked with gram positive and gram-negative bacteria, yeast and mould.

Obtained training in cell culture, bacterial colony counting, autoclaving and sterile techniques.

Performed Antimicrobial Effectiveness Testing using Classical Plate Method and Rapid Microbiological

Methods involving flow cytometry and solid phase cytometry.

Obtained thorough training in experimental design, method development, analyzing data and

organizing presentations.

Obtained thorough knowledge regarding different aspects of Protein instability.

Internship, Elysium Pharmaceuticals LTD, Vadodara, India. May, 2007-June, 2007

Trained in Quality Control, Quality Assurance, Manufacturing department (Capsule, Parenteral

products, Liquids) especially of Tablets (blending, granulating, drying, compressing and coating), B-

Lactum antibiotics and the Packaging department.

Obtained training for documentation as per GMP.

Internship, Food and Drugs laboratory, Vadodara, India. May 2006-July 2006

Performed different techniques of instrumentation including HPLC, TLC, IR, UV spectroscopy and gas

chromatography.

Conducted Wet Chemistry analysis, titrations (acid-base, Redox, Complexiometric, Precipitation),

Potentiometry, Polarogrphy, Ph metry, Conductometry, Colorimetry, Fluorimetry, Gravimetry.

Performed Microbiological analysis, LAL Test and pyrogen test and Sterility Testing.

Obtained training for Documentation as per Good Laboratory Practices Guidelines.

Prepared protocols and reports.

Developed deep understanding of SOP.

Obtained training in validation techniques.

Research Experience

Research worker, Laboratory of Dr. Ralph. Loring, Sep 2008-present

Northeastern University, Department of Neuropharmacology, Boston MA.

Projects handled:

• Investigated the role of chaperone protein creld2 on alpha4 beta2 nicotinic receptor assembly and

expression.

• Investigated the effect of chaperone protein pick1 on expression of alpha 7 nicotinic receptor.

Techniques learned:

• Hands on experience with mRNA purification, DNA extraction and purification, Gel electrophoresis, end

point PCR, qRT-PCR, Primer designing, validation and optimization, DNA sequencing, Cell culture-plating

and splitting cells, Miniprep, Maxiprep, Restriction Digest, Transfection, Autoclaving, Fluorescent

microscopy, radioactive binding assay, Transformation, Topo-cloning, Ligation and Agar plating.

• Worked with and maintained mammalian cell lines like GH4C1, HEK293, and SHEP1 along with

aseptically freezing and thawing cells.

• Obtained thorough training with ApE plasmid editor and Nano Drop.

• Obtained knowledge regarding Western blotting, siRNA and ELISA.

Research worker, Laboratory of Dr. J. Gately, Dec 2007-April 2008

Northeastern University, Department of Neuropharmacology, Boston MA.

Project handled: Radionuclide imaging and behavioral studies of drugs acting on the cannabinoid and

dopamine receptor systems.

Techniques learned:

• In vivo studies including dosing of the rodents by IV or IP injections

• Collecting samples of the heart, liver, adrenal glands, brain and the blood of rodents and counting the

radioactivity in it using a Scintillation counter.

Have undergone training for Hazardous waste, Radiation safety and Animal handling

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Other skills

Additional Laboratory skills: Performed Qualitative and Quantitative estimation of various biochemical

products and Protein Assays. Prepared and evaluated pharmaceutical dosage forms and cosmetic

products.

Computer skills: Proficient with MS office. Working knowledge of SPSS.

Presentation skills:

o Presented a poster on ‘Role of chaperone molecules regulating nicotinic receptor expression’

at Pharmaceutical science research showcase at Northeastern University.

o Delivered an oral presentation in journal club meeting on ‘Correction of fragile x syndrome in

mice’ at Northeastern University, Boston.

Recognition and awards

‘Industry ambassador award’ for 2009 at Northeastern University, Boston.

‘Best Intern Poster Presentation award’ at Pfizer, St. Louis.

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