Quality Assurance Development

HETA PARMAR

***** ***** **, ***** ****, NY *****

[m] 818-***-**** www.linkedin.com/in/hetaparmar ********@********.****.***

Always keen to walk an extra mile to attain excellence

(OPEN FOR RELOCATION)

EDUCATION:

• Polytechnic Institute of New York University, Brooklyn, NY. MS in Biotechnology (September 2010 –May 2012), GPA 3.57

• BK MODY Govt Pharmacy College (Saurashtra University), Rajkot, India. (July 2005 –May 2009) BS in Pharmacy, GPA 3.94

LAB SKILLS:

• Basic molecular biology techniques such as DNA purification, DNA gel electrophoresis, SDS-PAGE, ligation, restriction digestion and mapping, selection and screening of mutants, PCR including primer design, plasmid construction and design, cloning, DNA sequence analysis, and bacterial transformation;

• Basic microbiology techniques such as single colony purification, dilution series, plate counts, hemocytometer counts and aseptic technique.

• Working with rodents in pharmacology lab in undergraduate degree.

• Analytical techniques such as HPLC, UV Spectroscopy, Karl Fischer, colorimetry, Polarimetry, pH meter, FTIR, XRD, SEM.

• Observing GLP, Data documentation, following aseptic procedure and SOPs.

EXPERIENCE:

NYU College of Dentistry, NYC, NY [Feburary 2011 – Current] Research Assistant – Part time

• Assessing the anti-bacterial activity of Bio-Active glass used in orthopedic applications and study its resistance on S. aureus, P. aeruginosa and E. coli.

• Preparation of different glass compositions and characterization using SEM, XRD, FTIR, ICP and pH meter.

• Standardization of protocol for antimicrobial assay and analysis and interpretation of data and preparing graphs and charts.

• Growth Curve, UV Spectroscopy, cell culture maintenance, observing asepsis under laminar flow.

• Maintenance and calibration of equipments and supplies, literature referencing, documentation, sterilization.

• Interfacing between Biomaterial laboratory and BSL-2 Microbiology laboratory.

POLYTECHNIC INSTITUTE OF NEWYORK UNIVERSITY, Brooklyn, NY [September 2011-December 2011] Student- Genetic Engineering Lab.

• Isolation of DNA/RNA, extraction of DNA.

• Introduction of Kanamycin resistant gene containing recombinant DNA into E.coli by transformation and selection of transformants, extraction of supercoiled recombinant plasmid DNA, followed by restriction enzyme analysis

• Site Directed Mutagenesis of gfp at chromophoric site amino acid residues 65 to 67, Ser-Tyr-Gly to understand protein folding followed by PCR.

• Purification of Green Fluorescent Protein by column chromatography (size exclusion HPLC) and analysis on denaturing polyacrylamide gels (SDS-PAGE).

• Restriction enzyme mapping, ELISA.

ALEMBIC PHARMACEUTICALS Pvt. Ltd., Vadodara, India. [January 2010-June2010] Intern Part time

• Microbiology lab: Testing the QA of drugs raw material using AET- Antimicrobial Effectiveness Testing, Sterility Test, Direct Inoculation Test, Membrane Filtration Test, LAL Bacterial Endotoxin Test, MIC/MBC Test

• Quality Assurance: Analysis of API and excipients analysis of finished products as well as inprocess samples of Tablets (cephalosporins, aminopenicillin, macrolids, quinolones) Karl Fischer, Optical rotation and specific optical rotation, FTRI, GC, HPLC, UV and visible absorption spectrophotometry

B.K MODY GOVERNMENT PHARMACY COLLEGE, Rajkot, India. [July 2007-May 2009] Student- Pharmacology Lab.

• Common laboratory animals and anesthetics used in animal studies. Commonly used instruments and standard techniques in nonclinical assays.

• To record the concentration response curve (CRC) of acetylcholine using rectus abdominis muscle preparation of frog; histamine on guinea pig ileum preparation; noraderenaline on rat anococcygeus muscle preparation; oxytocin using rat uterus preparation.

• To calculate the pA2 value of atropine using acetylcholine as an agonist on rat.

• To estimate the strength of the test sample of agonist/drug (e.g. Acetylcholine, Histamine, 5 -HT, Oxytocin, etc) using a suitable isolated muscle preparation employing Matching biofunctional assay, Bracketing biofunctional assay, Three point biofunctional assay and Four point biofunctional assay.

ACADEMIC EXPERTISE:

• Early stage of target identification and generation of lead compounds to modern methods of drug delivery, preclinical development, clinical trials and regulatory requirements, High through put screening, assay development, determination of lead compound, SAR, SPR, ELISA.

• Molecular Immunology: understanding of the molecular basis and the cellular interactions that regulate the immune responses. Antibody structure, B-cell development, T-cell structure and development, T-cell-MHC interaction, MHC structure and antigen processing, complement chemistry, complement and Fc receptor structure and function, transplantation immunogenetics, mucosal immunology and allergic reactions

• Pharmacology: Pharmacogenetics. Absorption, Distribution, Metabolism and Excretion of drugs, Principles of Basic and Clinical pharmacokinetics, Adverse Drug Reactions, Pharmacology of PNS, CNS, CVS, GIT, Endocrine System, Clinical Pharmacology,

• Advanced Cell Biology: Understanding cell biology through teh biochemistry of the cell, with emphasis on the structure and function of the cell and its organelles. Advanced theories of cytoskeletal proteins, cell junctions and matrix, protein signaling and cell death.

• Genetic Engineering: DNA replication and repair, DNA extraction and recombination, restriction enzymes, DNA sequencing, gene manipulation and cloning strategies, PCR, RNAi technology, transgenic plants, DNA profile, bioinfomatics.

• Protein Engineering: techniques of protein determination, SSM, SPPS, rational design, direct evolution, post-translational modification, protein folding, combinatorial library.

• Neuroscience: The physiology and biophysics of neurons; neuronal signal transduction, gene expression and transport of RNA and protein; synaptic transmission and plasticity.

PROJECTS AND PRESENTATIONS:

• Development of novel drug “NoAzma” for asthmatic patient guided by Professor Evgeny Vulfson. This retrospective assignment covered market analysis and need for new drug for alleviating the cellular mechanism of asthma pathway. The medicinal hypothesis was based inhibition of my target; CD1d glycolipid receptor of iNKT cells. HTS would be performed using ELISA or SPR or ERK1/2 phosphorylation detection or competitive binding assay. The lead was DPPE-PEG derivative from which NCEs were developed and pharmacological profile was created. Biomarkers and animal model of choice was selected. Preclinical evaluation, determination of MTD/NOAEL, calculating MRSD, Efficacy and toxicological study in animals, IND summary, Gateways and Phase 1, 2, 3 (eligibility and exclusion), end point determination, updation of protocol, IB, CRF, ICF after every phase, NDA filing and life cycle management.

• Development of an engineered protein cocaine esterase from Rhodoccocus species for the treatment of cocaine overdose and addiction guided by Professor Jin Montclare (NYU Poly, 2012). Cocaine esterase is used to treat cocaine addiction and overdose but the half-life of protein is very short. We propose to incorporate residual modification to enhance its thermal stability through site directed mutagenesis and deriving PCR primers. We aim to monitor thermal stability and specificity using Circular Dichroism and specificity constant.

• A presentation on a study exploring the effects of expression of OVA-IL 10 DNA in asthmatic murine animal model guided by Professor John Katseigner. (NYU Poly, 2011). Recent studies have proved that immune-protective role IL 10 in asthma and the potential it holds the treatment of asthma. Thus, administration of OVA-IL 10 DNA plasmid in an individual would provides better and long lasting protection to models having a predisposition towards asthma. cDNA of IL 10 and OVA would be cloned by RT-PCR. The in vitro expression of the cDNAs would be confirmed using ELISA. The primary end points would be measured using westernblott, measurement of AHR, cytokine bioassay and Ab assay.

COMPUTER SKILLS: Operating system - Windows 2000, XP, Vista, 7 and Application packages – MS Office 2010 (Word, Excel, Powerpoint etc), Adobe, Photoshop etc.

Contact this candidate