Analytical method development and validation.
Resume:
CURRICULUM VITAE
SANTOSHKUMAR .S . DUBE
Opp-Manikrupa School,
I.OC Road, Chandkheda,
Ahmedabad - 382424.
Gujarat. India.
MOB. 997-***-****,917*********
Email: ***********@*****.***
Objective
To work in a competitive environment with sincerity, dedication,
responsibilities and challenge to prove myself in the exploring science
world with zeal to learn by scientific attitude and management skill.
PRESONAL DETAILS
> Name : SANTOSHKUMAR S. DUBE
> Date of Birth : 15th June, 1978
> Gender : Male
> Religion : Hindu
> Category : General
> Marital Status : married
> Nationality : Indian
> Hobbies : Reading Book, Cricket, Listening music
> Languages Known : Gujarati, Hindi, English
EDUCATIONAL PROFILE
Examination Board / University Grade
B.Sc (Chemistry) Gujarat University Second
M.Sc(Chemistry) Bhavnagar University Second
PROFETIONAL EXPERIENCE
Company Name Post Place Duration
Core Healthcare Ltd. Chemist Sachana 1.9 Year
Torrent Research Center Research Gandhinagar 3.2 Year
Assistant
Astron Research Ltd Research Ahmedabad 3.5Year
Associate
Zydus Cadila healthcare Research Bavla Since,
Ltd Scientist July,2010
Zydus Mexico Research Mexico 1 month
Scientist
OPERATIONAL EXPOSURE TO SCIENTIFIC EQUIPMENT
* Preparative HPLC (LC-8A, shimadzu).
* HPLC-2010C,10A (Class-VP Series, Shimadzu).
* HPLC (Agilent-1100, 1200 with ezichrom software).
* HPLC (Waters with Empower software).
* UV Visible spectrophotometer (shimadzu with UV probe
software)
* Dissolution Apparatus ( Make : Electro Lab with auto
sampler)
PROFETIONAL EXPERIENCE
Company Name Post Place Duration
Core Healthcare Ltd. Junior Chemist Sachana 1.9Year
PRESENT rESPONSIBILITY
* To perform analysis of raw material by titration method.
* Worked in a GLP laboratory.
* IPQA in production and packaging departments.
* To perform analysis of finish products.
* Reagent preparation.
* Volumetric solution preparation and standardization.
* To follow current good manufacturing practice and good
laboratories practices.
* Analysis of in process sample.
PROFETIONAL EXPERIENCE
Company Name Post Place Duration
Torrent Research Center Research Gandhinagar 3.2 Year
Assistant
PRESENT rESPONSIBILITY
* Analytical method development of related substance,
dissolution, content uniformity and Assay for different
type of formulations.
* Analytical method validation of related substance,
Dissolution, content uniformity and Assay for different
type of formulations.
* Technology transfer of analytical method by HPLC
* Method development for Drug release profile by
discrimination and Bio-relevant aspect.
* To perform analysis of routine and stability sample.
* Prepare the standard test procedure for finish product.
* To troubleshoot analytical methods as well as instrument
failures during day to day work.
* Impurity Isolation and characterization.
* Worked in a GLP laboratory.
* Performing analytical chemistry assays based on new and
existing methodologies for Solid Oral Dosage Forms (Tablet,
Capsules, etc.).
* To follows the system and procedure as per current
international regulatory requirement and to ensure their
compliance in day to day practice.
* Method validation of related substance and assay for Active
pharmaceutical ingredients by HPLC.
* Calibration of varies instruments like: pH meter, Karl
Fischer, Auto titerator, Melting point instrument, HPLC.
* To perform IQ, OQ, OPQ installation procedure of new
instrument in R& R Lab.
PROFETIONAL EXPERIENCE
Company Name Post Place Duration
Astron Research Ltd Research Ahmedabad 3.5Year
Associate
PRESENT rESPONSIBILITY
* Experience in different type of formulation like Tablets,
Capsule, product drug substance.
* Analytical method development of related substance,
dissolution, content uniformity and Assay for different
type of formulations.
* Analytical method validation of related substance,
Dissolution, content uniformity and Assay for different
type of formulations.
* Technology transfer of analytical method by HPLC
* Method development for Drug release profile by
discrimination and Bio-relevant aspect.
* Review the stability study analysis and routine analysis
for drug product (for Development batches).
* Compile the stability data and update the formulation
department regarding the results.
* Prepare method development report for finish product.
* Prepare and review the standard test procedure for finish
product.
* To troubleshoot analytical methods as well as instrument
failures during day to day work.
* Impurity Isolation and characterization.
* Worked in a GLP laboratory.
* Performing analytical chemistry assays based on new and
existing methodologies for Solid Oral Dosage Forms (Tablet,
Capsules, etc.).
* Preparation of method validation protocol of related
substance, assay, content uniformity and dissolution for
finished products.
* To follows and assist to develop the system and procedure
as per current international regulatory requirement and to
ensure their compliance in day to day practice.
* Method validation of related substance and assay for Active
pharmaceutical ingredients by HPLC.
* Calibration of varies instruments like: pH meter, Karl
Fischer, Auto titerator, Melting point instrument, HPLC, UV
spectrophotometer, Dissolution apparatus, and Hamilton
dilutor.
* To perform IQ, OQ, OPQ installation procedure of new
instrument in R& R Lab.
PROFETIONAL EXPERIENCE
Company Name Post Place Duration
Zydus Cadila healthcare Research Bavla Since,
Ltd Scientist July,2010
PRESENT rESPONSIBILITY
* Experience in different type of formulation like Tablets,
Capsule, product drug substance.
* Analytical method development of related substance,
dissolution, content uniformity and Assay for different
type of formulations.
* Analytical method validation of related substance,
Dissolution, content uniformity and Assay for different
type of formulations.
* Technology transfer of analytical method by HPLC
* Method development for Drug release profile by
discrimination and Bio-relevant aspect.
* Work distribution.
* Review the stability study analysis and routine analysis
for drug product (for Development batches).
* Compile the stability data and update the formulation
department regarding the results.
* Prepare method development report for finish product.
* Prepare and review the standard test procedure for finish
product.
* To troubleshoot analytical methods as well as instrument
failures during day to day work.
* Prepare and review API verification report.
* Impurity Isolation and characterization.
* To perform method equivalency and deficiency work.
* Prepare method equivalency report.
* Worked in a GLP laboratory.
* Performing analytical chemistry assays based on new and
existing methodologies for Solid Oral Dosage Forms (Tablet,
Capsules, etc.).
* Preparation of method validation protocol of related
substance, assay, content uniformity and dissolution for
finished products.
* To follows and assist to develop the system and procedure
as per current international regulatory requirement and to
ensure their compliance in day to day practice.
* Method validation of related substance and assay for Active
pharmaceutical ingredients by HPLC.
* Preparation of method validation protocol of related
substance, assay, Active pharmaceutical ingredients.
* Method development of Cleaning Validation.
* Prepare cleaning validation report.
SEMINAR / TRAINING ATTANDED
* Sap-R/3-PPC functional training from software technology
(Duration-2 Month).
* Undergone training in VFLC and mass spectrometer instrument
from shimadzu (one-Day).
TECHNICAL EXPOSURE
* Involved with set up/established R&D analytical laboratory.
* Handled analytical related activities i.e. compile
stability data for development batches review impurity
trend of development batches.
* Calibration of varies instruments like: pH meter, Karl
Fischer, Auto titerator, Melting point instrument, HPLC, UV
spectrophotometer, Disssolution apparatus, and Hamilton
dilutor.
* Activity involved in method development and method
validation for finish product, method validation for Active
pharmaceutical ingredients.
* Technology transfer of analytical method by HPLC at Mexico
for one month.
SPECIAL FEATURES
* Having knowledge in the basic computer and operating
system.
* Having knowledge in the calibration procedure and basic
trouble shooting of instruments.
Yours truly,
SANTOSHKUMAR DUBE
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