Quality Control Training

PROFILE

. Masters in Biotechnology with extensive professional and laboratory

experience in Protein Purification and Characterization, Drug

delivery and Drug formulation

. Demonstrated research experience with 3 credited publications in

international journals

. Highly motivated and enthusiastic with excellent verbal and

written communication skills

. Experience in writing technical and development reports including

patents

. Strong grasp of cGMP and other federal regulatory standards, OSHA

trained

LAB SKILLS

Analytical Techniques:

. Protein Purification and Characterization

Purified novel recombinant proteins from E.Coli (His tagged, non

tagged)

. Hands on experience Tangential Flow Filtration

. Affinity Chromatography(IMAC Column)

Purified recombinant protein by Immobilized metal ion affinity

chromatography

. Hands on experience in High Performance Liquid Chromatography

Monitored concentrations of analytes (glucose,

acetate) by HPLC

. Dissolution and Disintegration Studies

Determined disintegration and dissolution time for compressed

coated tablet 'Diclofenac Sodium' using disintegration and

dissolution apparatuses

. Working knowledge of Mass Spectrophotometry and AKTA operation

. UV and Fluorescence Spectrophotometry

Molecular Biology: Real-time PCR, Primer Design, Plasmid Purification,

Southern Blot, Western Blot, Sequencing and Genotyping Assays, DNA

Sequence Analysis, SDS-PAGE, Gel/Capillary Electrophoresis

Cell Culture: Transfection, Transformation, Generation of stem cell

from mouse bone marrow, Immunocytochemistry, Maintaining Mammalian and

Bacterial Cell Lines for cell based assays, Media preparation,

Cryopreservation, Flow Cytometry, Wright and Giemsa staining

Immunology: ELISA, Cell Viability Determination, Antigen Preparation,

Immunoglobulin Isolation, Hybridoma and Monoclonal Antibody

Preparation

COMPUTER SKILLS

Microsoft Office Suite, Windows XP/Wista/7

WORK EXPERIENCE

Protein Formulation Intern

MedImmune LLC, Gaithersburg, MD

(June 2013-Present)

Publishing a Scientific Paper in the lab of Dr. Murali Bilikallahalli

(Senior Scientist and Group leader at MedImmune(AZN)

. Used Biophysical Techniques like Isothermal Titration Calorimetry

and Dynamic light scattering during formulation process

. Applied Circular Dicroism (CD) Spectroscopy in determining

conformational changes due to interactions of asymmetric molecules

. Determined Critical Micellar Concentration by surface tension

method

. Gained hands on experience with SEC-HPLC and RP-HPLC

Research Associate, Massachusetts Biomanufacturing Center

(MBMC)

University of Massachusetts Lowell

(Sep 2011-April 2013)

Bioprocess, Analytical development and Protein characterization

. Successfully monitored concentrations of samples/analytes

(glucose, acetate) by HPLC

. Purified protein by Immobilized Metal Ion Affinity

Chromatography (IMAC Column)

. Developed growth curves, carbon source depletion curves and

acetate accumulation

. Estimated protein concentration using UV-Vis Spectroscopy, SDS

PAGE

Cell Biologist (Intern)

Immunotrex Biologics, Inc. Massachusetts, USA

(May-Aug 2012)

. Designed small size peptides KdeonTM using Polymyxin B as a model

molecule which interact effectively with and neutralize

Lipopolysaccharide (LPS) in the blood stream of patients having

sepsis

. Used ELISA to analyze effect of peptides in neutralizing injurious

effect of LPS

. Followed protocol to measure and record observations

Research Assistant, University of Pune, India

(Sep 2009 -Jan 2011)

1. Development of enzyme controlled colonic drug delivery using

amylose and hydroxypropyl methyl cellulose: optimization by

factorial design (Published)

. Developed colon specific drug delivery systems for diclofenac

sodium which release drug specifically and instantly at

target site using amylose as carrier

. Prepared compression coated tablets of diclofenac sodium

containing amylose and HPMC

. Performed In vitro and In vivo drug release studies by changing pH

method with enzyme

Quality Control Analyst

Briocia Pharma, Maharashtra, India

(Oct 2008-Aug 2009)

. Gained exposure in cGMP regulated production and quality control

department

. Gained experience in tablet and capsule production

EDUCATION

Masters of Science (Biotechnology)

(May 2013)

University of Massachusetts, Lowell, MA

PUBLICATIONS

S J Kshirsagar, M R Bhalekar, N S Shewale, V P Godbole, P K Jagdale,

S K Mohapatra; Development of enzyme controlled colonic drug

delivery using amylose and hydroxypropyl methyl cellulose:

optimization by factorial design; Drug Delivery, 2011, 1-9

S V Gandhi, P B Deshpande,P K Jagdale,V P Godbole; A simple and

sensitive method for simultaneous estimation of Artesunate and

Amodiaquine In combined tablet dosage form; Journal of Chemical and

Pharmaceutical Research, 2011,1-6

S V Gandhi, P B Deshpande,P K Jagdale,V P Godbole; A validated

reverse phase HPLC method for simultaneous determination of

Telmisartan and Ramipril as bulk drug and in tablet dosage form;

Journal of Chemical, Biological and Physical sciences, 2011,1-6

CERTIFICATIONS

. Lab safety Training: Laboratory safety and compliance training

certified by EPA and OSHA

. Blood borne pathogen/Biosafety Training: Certified by EPA and OSHA

Contact this candidate