CURRICULUM VITAE

Selvaraja Elumalai

E-mail id: acdbem@r.postjobfree.com

****,********* *******,******-*****

Cell no: +1-732-***-****

OBJECTIVE:-

To seek a challenging career that enables me to utilize my current

skill set towards helping my organization remain competitive and

innovative. At the same time, to choose opportunities that helps me sharpen

and improve upon my talents.

EXPERIENCE:-

Current Job;

Designation: Senior Scientist-

Organization: Medcore Pharma LLC,NJ,USA.

Years: Oct2012

Responsibilities:

> In-charge for the Quality and Analytical division for the project

delivery.

> Handling a development team with 12 Research associates for Solid

dosage forms

> Co-ordination with Vendor for the DMF related issues in

Analytical methods and Specifications

> In-Charge for the cGMP and GLP activities.

> Reviewing analytical method validation and development documents

like Assay, Related Compounds, Dissolution and other analysis

> Reviewing STP and Sop's for analytical department related products

and instruments.

Designation: Scientist-1

Organization: Aurobindo Pharma Ltd, Hyderabad,India.

Years: Jul-2010 to Oct2012

Responsibilities:

> In-charge for the Analytical method development division for the

project delivery.

> Handling a development team with 8 Research associates for Liquid

dosage forms, Oral Contraceptives and Ophthalmic

> Co-ordination with Vendor for the DMF related issues in

Analytical methods and Specifications

> Development for Assay, Bio assay (Like Heparin and Enoxaparin

molecules) and Related Substance for parental dosage form,

ophthalmic solutions and Oral contraceptives.

> In-Charge for the cGMP and GLP activities.

> Coordinating with third party vendor for method verification of

analytical methods.

> Leading tech transfer team for Solid oral dosage forms and API.

> Reviewing analytical method validation and development documents

like Assay, Related Compounds, Dissolution and other analysis

> Reviewing STP and Sop's for analytical department related products

and instruments.

> Preparation of protocols and conducting validations for products

intended for Generic market.

> Ensuring lab compliance as per regulatory requirement.

> Co-coordinating with purchase division to negotiate the price for

columns and impurities

> Crucially worked for cost reduction activities.

> Co-coordinating with project management team about the project

updates as per the current market strategy.

Designation: Deputy Manager

Organization: Genovo Development Services Ltd,

Bangalore,India.

Years: Nov 2009 to Jul 2010

Responsibilities:

> In-charge for Pilot plant activities.

> Handling a team of 14 analyst for the Solid dosage forms .Includes

analytical Development,Validation and final project stability

activities

> Preparation of Specifications and Standard testing procedure for

the pilot plants.

> Preparation of documents for Vendor qualification as per the DMF

requirements.

> Preparation and execution of Analytical method verification and

method validation for API.

> Preparation and execution for the method transfer activities .(

Inter and Intra lab)

> Preparation and execution Method Equivalency as per USP

requirements.

Designation: Senior Scientist

Organization: Actavis Pharma, Chennai,India.

Years: Aug 2007 to Nov2009

Responsibilities:

> Leading development team with 5 scientist and additional

responsible for support team of 4 scientist.

> In-charge for the Lab establishment as per the USFDA facility

requirements.

> In-Charge for the System Security activities of Empower server and

systems.

> Co-ordination with Vendor for the DMF related issues in

Analytical methods and Specifications

> Coordinating with third party vendor for method verification of

analytical methods.

> Leading tech transfer team for Solid oral dosage forms and API.

> Reviewing analytical method validation and development documents

like Assay, Related Compounds, Dissolution and other analysis

> Reviewing STP and Sop's for analytical department related products

and instruments.

> Preparation of protocols and conducting validations for products

intended for Generic market.

> Ensuring lab compliance as per regulatory requirement.

> Preparation of Specifications and Standard testing procedure and

reviewing DMF documents.

> Preparation of annual reports for the lab activities.(Coasting

activity).

> In charge for the Optimization batch activities.

> Preparation of Instrument IQ, OQ, PQ protocols and execution of

the protocols for HPLC, DSC, Dissolution, Balance.

> Leading the team with eight peoples and execution of RS, Assay,

Dissolution method validation and development.

> Performing Computer System Validation for Empower Client.

> Preparation of SOP related to analytical instruments as per the

Lab requirements

Designation: Junior Manager

Organization: Dr.Reddy's Laboratories (Generics Division), Hyderabad,India.

Years: 2005 to 2007

Responsibilities:

> Method Development:

Development of Analytical Methods for Solid dosages, Injections,

Ophthalmic solutions as per USFDA & ICH guidelines for Related

Substances, Assay, Dissolution, CU, UOD. Infusion Study, Stability

studies of Premix Solutions.

> Method Validation:

Able to execute independently validation protocols for validation of

analytical methods for routine quality control analysis as per USFDA

& ICH guidelines for all product parameters.

Preparation of summary reports for Dissolution, Related Substance,

Assay, CU, Residual solvents, Residue analysis & UOD method

validation protocols and Infusion study reports which later become

part in ANDA submission.

> Calibrations:

Carried out calibrations for different HPLC'S and Dissolution

Systems, Analytical Balances, Differential Scanning Colorimeter (DSC-

823).

> Actively participating in product development strategies ensuring

the timely completion of projects.

> Exploring latest analytical developments in the pharmaceutical

industry.

> Literature survey for project, guidelines and updating the current

developments in analytical field.

> Ensuring the Analytical Method Development and method validation

of Projects from Commercial lab to US lab For Paranteral dosage

forms.

> Reference & Working Standards:

Analysis of working standards for drug products.

Supporting in procurement of calibrations

reference standards

Designation: Executive

Organization: Strides ArcoLabs Pvt. Ltd, Bangalore,India.

Years: 2004 to 2005

Responsibilities:

> Method Development:

Development of Analytical Methods for Solid dosages, Injections, as

per USFDA & ICH guidelines for Related Substances, Assay,

Dissolution, CU, UOD.

> Method Validation:

Able to execute independently validation protocols for validation of

analytical methods for routine quality control analysis as per USFDA

& ICH guidelines for all product parameters.

Preparation of summary reports for Dissolution, Related Substance,

Assay, CU, Residual solvents, Residue analysis & UOD method

validation protocols and Infusion study reports which later become

part in ANDA submission.

> Reviewing analytical method validation and development documents

like Assay, Related Compounds, Dissolution and other analysis

Designation: Executive

Organization: Cavin Kare Pvt. Ltd, Pondicherry,India.

Years: 2002 to 2003

Responsibilities:

> Reviewing analytical method and development documents like Assay

activities.

> Reviewing STP and Sop's for analytical department related products

and instruments.

> Preparation of protocols and conducting validations for products

intended for Generic market.

> Ensuring lab compliance as per regulatory requirement.

> Working with QA department for the analytical related issues.

INSTRUMENTAL KNOWLEDGE

Having knowledge in handling, Calibration & troubleshooting of

> High Performance Liquid Chromatography DAD / PDA (Waters, Agilent &

Shimadzu)

> Dissolution apparatus (I,II,III,IV) (Lab India, Electrolab, Vankel )

> Differential Scanning Colorimeter (Shimadzu)

> Atomic Absorption Spectroscopy

> Particle size analyzer (Malvern )

> FT-IR Spectrophotometer (Shimadzu & Perkin Elmer)

> UV Spectrophotometer (Varian & Shimadzu)

> Auto titrator (Metrohm)

> Karl Fischer Auto titrator (Metrohm)

> Polarimeter (Jasco)

> Melting point apparatus (Mettler Toledo)

Achievements:-

> Letter of Appreciation from Vice President R&D of Dr. Reddy's Labs for

solving the dissolution problem in FLUOXETINE DR CAPSULES by USP III

apparatus and hence helping in USFDA filing of the product.

> Letter of Appreciation President R&D of Dr. Reddy's Labs for method

development of GRANISETRON HCL and IRINOTECAN HCL Injections within a

short period of time and hence helping in USFDA filing.

.

ACADEMIC QUALIFICATION:-

> MSc.,Physical Chemistry, with Ist class, (University of Madras, Chennai-

25.)

BSc.Chemistry(First Class) St.Joseph's

Collage of Arts & Science Cuddalore, Madras

University.

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