Quality Control Assurance

Manish Makhija

*** * **** **, ************, NJ **865

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

Ph: 1-201-***-****.

SUMMARY

. Research Assistant (MS IN PHARMACOLOGY) having 4 years

of experience in Pharmaceutical Research and has worked

on various quality control aspects. (2 years of

experience in industry and 2 years in Academics). Worked

during various phases of Drug life cycle such as Raw

material Analysis, Pharmacokinetics and Pharmacodynamics

properties.

. Hands on experience with Biotechnology & Pharmaceutical

R&D.

. Core areas of skill are Pharmaceutical Research and

Quality control.

SKILLS

Techniques and Methods

DNA extraction, Protein

purification, Protein

Extraction, ELISA, PCR,, Gel

Electrophoresis, Western

Blot, Tissue culture growth,

Agonist/Antagonist Response on

muscle contraction and

relaxation on animals, GC,

HPLC.

Medical Tools Digital spectrophotometer, Flame

photometer, Electronic

microscope, Kymograph

technology, Autoclave Lab

Fermentor, Mass Mixing

Machine, Pulverizer,

Granulator, Suppository Mold,

Petri Dish Incubators, Flow

cytometry.

Job Functions Lab testing, monitoring the batch

process, performing quality

line checks, organizing

retention samples, testing of

finished goods, monitoring

label information,, SOP

writing, Distillation,

Filtration, GMP maintenance.

Computer Skills

LIMS, Win7, Win2000, WinXP,

Personal Computer, Microsoft

Office Suite, internet

Research.

TECHNICAL PROJECT SUMMARY

DOX INDUCED CARDIOTOXICITY Prolyl hydroxylase 3 interacts with Bcl-2 to

regulate PREVENTION (2010)

doxorubicin induced apoptosis in H9c2 cells

Prolyl hydroxylases (PHDs) are dioxygenases that

use oxygen as a co-substrate to hydroxylate

proline residuesPHD3 expression is upregulated

in some cardiac diseases such as cardiomyopathy,

myocardial ischemia reperfusion injury and

congestive heart failure, all of which are

associated with apoptosis. PHD3 upregulation may

be partially responsible for DOX-induced

cardiomyocyte apoptosis via its interaction with

Bcl-2. Inhibition of PHD3 is likely to be cardio

protective against apoptosis in some heart

disorders.

ALZHEIMER'S DISEASE (2010) The apolipoprotein E 4 allele plays

pathological roles in AD through

high protein expression and interaction with butyrylcholinesterase.

Apolipoprotein E (19q) protein plays an

important role in the metabolism, transport and

redistribution of cholesterol carriers. In

vitro studies suggest that synthetic beta

amyloid peptides readily form complexes with

human ApoE protein.

Duchenne Muscular

Dystrophy (2010) Effect of creatine monohydrate in improving cellular

energetics and muscle strength in ambulatory

Duchenne muscular dystrophy patients

Randomized, placebo-controlled single blinded

study was carried out to evaluate the effect of

oral creatine supplementation on cellular

energetics, manual muscle test (MMT) score and

functional status in steroid-naive, ambulatory

boys suffering with Duchenne muscular

dystrophy.

Familial

Hypercholesterolemia (2010) Mipomersen, an apolipoprotein B synthesis

inhibitor, for lowering of

LDL cholesterol concentrations in patients

with homozygous FH

Homozygous familial hypercholesterolemia is a

rare genetic disorder in which both LDL-

receptor alleles are defective, resulting in

very high concentrations of LDL cholesterol in

plasma and premature coronary artery disease.

This study investigated whether an antisense

inhibitor of apolipoprotein B synthesis,

mipomersen, is effective and safe as an

adjunctive agent to lower LDL cholesterol

concentrations in patients with this disease.

Inhibition of apolipoprotein B synthesis by

mipomersen represents a novel, effective

therapy to reduce LDL cholesterol

concentrations in patients with homozygous

familial hypercholesterolemia who were already

receiving lipid-lowering drugs, including high-

dose statins.

TRANSGENIC PLANTS (2010) Transgenic chickpeas (Cicer arietinum L.)

expressing a sequence

modified cry2Aa gene.

A cry2Aa gene with a sequence-modified open

reading frame encoding an insecticidal

crystal protein from Bacillus thuringiensis was

introduced into chickpea (Cicer arietinum L.) to

confer resistance to Helicoverpa armigera (pod

borer). A high expressing line was found to

confer near complete protection against the pod

borer. We concluded that a sequence-modified

cry2Aa gene expressed in chickpea is effective

against pod.

ACETYCHOLINE

NEUROTRANSMITTER (2009) Adrenergic Neurotransmitter Functions

The project describes the invention of word

adrenergic and the release process and

distribution of Ach neurotransmitter in the body.

EYE CANCER (2007) Unilateral retinoblastoma, lack of

familial history and older age does not exclude

germ line RB1 gene mutation.

Conclusive identification of RB1 mutations

in retinoblastoma is predicted to improve the

clinical management of affected children.

However, despite clear clinical

benefits, RB1 screening remains difficult, most

of the alterations being unique and randomly

distributed throughout the entire coding

sequence.

EXPERIENCE

DEC 2010 Long Island University

TO MAY 2011 Graduate Assistant

Hands on Experience with;

. Western blot; analytical technique used to detect

specific protein in the given sample of tissue

homogenate or extract.

. Gel electrophoresis; is most commonly used for

distributing and separating biological macromolecules

namely Proteins, DNA or RNA.

. DNA extraction; technique very well known for its use

in forensics and molecular analysis.

. DNA fragmentation; technique used to break the DNA

strand, DNA fragmentation is seen in Apoptosis.

June 2008 ZYDUS CADILA

To August 2009 Research Scientist

. Analyzing samples from various sources to provide

information on compounds or quantities of compounds

present; using analytical techniques and

instrumentation, such as gas and high performance liquid

chromatography (HPLC).

. Performed protein purification techniques.

. Prepares SOPs and Work Instructions.

. Responsible for quality control limit of the product.

. Coordinate toxicological, microbiological and efficacy

testing department for preparation/approval of test

protocols and assay performance.

March 2007 HAFFKINE BIOPHARMCEUTICALS LTD

To July 2007 Quality Analyst

. Worked on cell culture growth.

. Performed Sterility testing (Culture media, Incubation

period)

. Performed Pyrogen testing (Limulus amebocyte lysate

test)

. Packaging integrity check for parenterals.

. Prepare and maintain a variety of routine laboratory

records using

laboratory information management system (LIMS)

July 2007 JJ Hospital

To November 2007

Quality Assurance

. Experience with stability, In process testing in GMP

environment.

. Chemical Analysis of the molecule, HPLC and GC

Techniques.

. Disintegration, Dissolution test for solid dosage forms.

. Prepare and maintain a variety of routine laboratory

records (LIMS).

EDUCATION / CERTIFICATIONS

. Masters in Pharmacology and Toxicology, Long Island

University, New York

. B.S. in Pharmacy, Mumbai University, India

. Certified on Technical course on Functional Aspects of

Medical device Industry including QA, GMP, Validation,

Packaging.

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