Pvt Ltd Development
Resume:
Professional Details
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Career Summary
To utilize my strength in achieving the objective of the organization and
to contribute to the projects that will not only enhance my learning curve
but also give me opportunity to be in the strategic decision making area in
the future.
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Professional Profile
Approximately nine years of experience in pharmaceutical industry with
specialization in BA/ BE Studies for regulatory like US-FDA, EMEA, ANVISA,
WHO, MOH-Turkey, DCGI. Completed pharmacokinetic and bioequivalence studies
with various study designs like two way, three way and 4- period replicate
study designs, parallel study design and multiple dose studies.
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Technical Skills
1. Liquid Chromatograph Mass Spectrophotometer (LCMS/MS, MDS Sciex API
2000, 3000, 3200, 4000,5500)
2. High Performance Liquid Chromatograph with (UV/Fluorescence/ECD
Detector)
3. Gas Chromatograph with (ECD/FID Detector)
4. Supercritical Fluid Chromatograph/Extractor (pcSFC/SFE)
5. Solid Phase Extractor
6. UV-Vis, Spectrophotometer
7. FTIR, Spectrophotometer
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Industry Experience
. C. B. Patel Research Centre for Chemistry and Biolagical Sciences
. Sun Pharmaceutical Industries Pvt Ltd
. Ivax India Pvt Ltd
. Accutest Research Laboratories Pvt Ltd
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Work Experience
Current: 07-Mar-07 to Continue
Drug Monitoring Research Institute Pvt Ltd.
Designation: Deputy General Manager
Functional Area: Bio-Analytical
Job Profile:
1. To provide scientific management to facilitate the development and
validation of LC- MS analytical methods. Methods developed should
be efficient, specific, robust and sensitive.
2. To effectively manage and develop teams and personnel in the
section.
3. To ensure work is conducted in compliance with the requirements of
Good Laboratory Practice, Health & Safety legislation/guidelines
and company policies/SOPs.
4. Documentation review and audit Compliance
5. To ensure that Bioanalytical or other studies assigned to the
section are conducted efficiently and effectively.
6. Successfully submitted the Bioavailability-Bioequivalence phase I
projects to various regulatory authorities (MCC South Africa, UK
MHRA, MOH Turkey, EU, WHO and DCGI).
7. To ensure that the scientific and technical standard of the work is
at the forefront of the industry.
8. To work with Business Development and Senior Management to
facilitate the development of new and existing sponsors.
9. Experience in facing audits of MCC South Africa, MOH Turkey, UK
MHRA and various sponsor audits(both National and International).
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Past: March 2006 to Feb 2007
Accutest Research Laboratories Pvt. Ltd.
Designation: Bio-Analytical Executive
Functional Area: Bio-Analytical Department
Job Profile:
. Development and validation of LC-MS/MS methods to quantitate a broad
range of analytes from biological samples
. Perform pharmacokinetic analysis of study data.
. Develop Sop, Validation Protocols and reports characterize the
ADME/PK/PD properties of biological compounds.
. Actively involve in audits of various regulatory authorities (FDA,
Annvisa, EU, WHO).
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Past: July 2005 to February 2006
Ivax India Pvt Ltd
Designation: Analytical Executive
Functional Area: Analytical Department
Job Profile:
. Worked as an Analytical Executive in Analytical Development lab.
. Carried out method development and validation as per ICH guidelines
for ANDA submissions.
. Develop Sop, Validation Protocols and reports for ANDA submissions.
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Past: December 2003 to June 2005
Sun Pharmaceutical Industries Pvt Ltd
Designation: Research Assistant
Functional Area: Analytical Department
Job Profile:
. Worked as an Research Assistant in Analytical Development lab.
. Carried out method development and validation as per ICH guidelines
for ANDA submissions.
. Responsible for sucessful tech transfer and validation of developed
Analytical method to USFDA approved lab.
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Past: July 1999 to November 2003
C. B. Patel Research Centre for Chemistry and Biological Sciences
Designation: Junior Chemist
Functional Area: Bio-Analytical/Analytical Department
Job Profile:
. Worked as an Junior Chemist in Analytical Development lab.
. Carried out method development and validation as per ICH guidelines.
. Carried out Bio-Analytical method development, validation of various
products as per fda guidelines on HPLC (UV, Fluoroscence and
electrochemical) and GC (FID, ECD Detector).
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Personal Details
Communication
Permanent Address
C2,302, Khamaj CHS, Kavyadhara Complex, Dhokali Naka, Kolshet Road, Thane-
400607
Contact No. Tele. No. +91-22-243***** Cell No. +91-
E-Mail Add. abwvev@r.postjobfree.com
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General
Date of Birth. 02nd Aug, 1977 Age 35Yrs
Passport Status Valid
Marital Status Married
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Academic
Doctoral degree [Ph.D] - in Analytical Chemistry (Thesis entitled -
'PHYSICAL BEHAVIOUR OF SOME DRUGS IN SUPERCRITICAL FLUID'.) Obtained in
March 2007 from University of Mumbai.
Post-graduate degree - Master of Science, M. Sc (Research), in Chemistry
(Thesis entitled - 'PHYSICAL BEHAVIOUR OF SOME DRUGS IN SUPERCRITICAL
FLUID'.) Obtained in August 2002 from University of Mumbai.
Diploma in Industrial Analytical Chemistry (D.I.A.C).
Graduate degree - Bachelor of Science, B.Sc. Obtained in May 1998 from
University of Mumbai.
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Publications & Presentations
Automated solid phase extraction method for quantification of montelukast
in human plasma using LC-MS/MS and its application to a bioequivalence
study
Global Journal of Analytical Chemistry: 1 (2) 2010, 109-180
Validated LC-MS/MS method for determination of piperaquine in human plasma
for its pharmacokinetic study
Global Journal of Analytical Chemistry: Accepted on 17 Feb 2011
Alternative LC-MS/MS method for simultaneous determination of artemether
and dihydroartemisinin in human plasma and its application to a
bioequivalence study.
Global Journal of Analytical Chemistry: Accepted on 16 Jun 2011
Validated LC-MS/MS method for quantification of agomelatine in human plasma
and its application in a pharmacokinetic study.
Journal of mass spectrometry- Accepted on 4 Nov 2011.
Liquid Chromatography/Tandem Mass Spectrometry for the Simultaneous
Determination of Alverine and
its Metabolite, Monohydroxy Alverine, in Human Plasma: Application to a
Pharmacokinetic Study
E-Journal of Chemistry 2011, 8(1), 201-211
LC-MS-MS method for simultaneous determination of proguanil, its active
metabolite in human plasma and application to a bio-equivalence study.
J. of Chromatography: DOI: 10.1365/s10337-009-1259-9, 70 (7/8) 1095-1102,
2009
Determination of Atovaquone in Human Plasma by LC-MS-MS and Its Application
to a Bioequivalence Study.
J. of Chromatography: DOI: 10.1365/s10337-009-1220-y 0009-5893/09/09, 70
(5/6) 947-951, 2009.
Estimation of Pioglitazone in Human Plasma by RP-HPLC.
THE INDIAN PHARMACIST, SEP 2002
Estimation of Zolpidem in Human Plasma with fluorimetric detection.
THE INDIAN PHARMACIST, SEP 2002
Application of Packed Column Supercritical Fluid Chromatography to the
Simultaneous Determination of a Four-Component Anti-Cold Multi-sympomatic
Pharmaceutical Dosage Form.
INDIAN DRUGS 39(8) AUG 2002.
Concurrent Assay of Lamivudine and Zidovudine from Dosage Form.
INDIAN JOURNAL OF PHARMACEUTICAL SCIENCE, 65 (4) 412-414, 2003
Isocratic Separation And Simultaneous Estimation Of Three Proton
Pump Inhibitor Drugs Using Packed Column Supercritical Fluid Chromatography
INDIAN DRUGS 42 (787-791) DEC 2005
Concurrent Assay of Lamivudine and Zidovudine from Dosage Form.
53rd Indian Pharmaceutical Congress, New Delhi Dec. 2001
Estimation of Pioglitazone, An Antidiabetic Drug in Human Plasma by RP-
HPLC.
54th Indian Pharmaceutical Congress, Pune Dec. 2002
Packed Column Supercritical Fluid Chromatographic Separation and Estimation
of Camylofine-2HCl and Acetaminophen in Pharmaceutical Dosage Form.
54th Indian Pharmaceutical Congress, Pune Dec. 2002
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Certificates
1. Successfully completed advanced training for operation and maintenance
of API 3000/2000 LCMSMS
at Foster City, California from Applied Biosystem.
2. Obtain certificate for ICH-Good Laboratory Practice training held at
Drug Monitoring Research
Institute, Navi Mumbai and conducted by Dr. Kamal Padgaonkar (MD,
Pharmacologist).
3. Obtain certificate for Clinical Research-Advanced GCP & BA/BE Stuidies
training held at Drug
Monitoring Research Institute, Navi Mumbai and conducted by Dr. Milan
Satia.
4. Participated in workshop for Recent Trends, Challenges and solutions in
Bio Analysis held at
Mumbai and conducted by Chromatographic Society of India.
5. Participated in 3 day workshop for in vitro-in vivo correlation (IVIVC),
Biowavers & Statistical
aspects of Bioequivalence in drug Produt Development held at Mumbai and
organized by
Pharma Edge Centre (I) Pvt Ltd.
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Language Competency
Language Ability to Speak Ability to Write Ability to Read
Hindi Yes Yes Yes
English Yes Yes Yes
Marathi Yes yes Yes
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Hobbies & Interests
Reading, Cricket, Internet Surfing & Travelling.
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References
Will be provided on request.
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Thank you for your time in reviewing my CV.
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