Development Plant
Resume:
Gandhi Hemant Madhusudan
Opp Railway Booking office,
Pune, Maharashtra, India:- 411002.
Mobile No: +91-976*******, 989*******
Email id: **************@*****.***
OBJECTIVE :-
Seeking challenging roles and responsibilities in the area of Analytical Research & Development associated with Formulations (Generics / NCEs / Custom Pharmaceutical Services).
SUMMARY :-
10 years expertise in Analytical Research and Development for different kinds of Pharmaceuticals viz Tablets, Capsules, Syrups, Opthalmic Solutions, gums, etc.
Lead a team responsible for completion of analytical method development, validation and transfer to USFDA approved plant for registration/exhibit batches for ANDA and NDA submission.
Capable to interprit LC-MS/MS and NMR data for Structural elucidation of known and unknown Impurities
Functioned as Analytical Lead in impurity profile and characterization.
Good interpersonal and communication skills.
Strong analytical, technical and diagnostic and managerial skills as part of professional temperament.
Result oriented individual, with ability to work in cross-functional teams, and achieve objectives in a timely manner that meets and / or exceeds customer expectations.
Possess skills of building and managing a team of highly professional and motivated scientists through well established leadership traits
Possess a flexible and detail oriented positive attitude.
Techniques known :-
HPLC / RRLC / UPLC SHIMADZU VP Series, LC2010 with class VP software, Dionex with chromeleon software, Waters (Empower) & Agilent With Chemstation.
LC-MS-MS API-3200 Q-Trap, LCQ Advantage, Thermo-Finnigan
NMR
Experiment BRUKER (300MHz & 400MHz)
1H, 13C, DEPT (45, 90, 135), APT, HMBC, HMQC, NOE, COSY, NOESY
Dissolution Apparatus Electrolab (08 L)
Gas Chromatography Perkin-Elmer, Agilent
XRD PANanalytical
Preparative-HPLC Waters Auto injector and Sampler
DSC & TGA TA instruments (Q Advantage) and Mettler Toledo
PROFESSIONAL EXPERIENCE
Cipla Limited.
Designation : Manegment Staff
Duration : August 2011-till date.
Responsibilities: -
Lead a team of 7-8 scientists, responsible to deliver good quality of analytical support to formulation R&D within the defined project timelines for developing a bio equivalent product
Responsible to provide analytical support to FR&D for development, stability, clinical trial batch manufacturing, process evaluation batches and pilot batches.
Review and approve raw data, record of analysis and other reports prepared by team members.
Technical guidance to team members and supervising method development, part method validation and other analytical activities.
Successfully transferred validated methods to plant QC for the execution of submission batches made for ANDA and NDA filing for global market.
Continuous support to improve and implement systems.
Writing SOPs, method development, validation, method transfer protocols and reports.
Orientation of team members towards team/company goals and helping them to overcome the challenges in order to achieve team/company goals.
Support for lab compliance and maintenance.
Sandoz Pvt. Ltd.
Designation : Scientist-III
Duration : May 2008-August 2011.
Responsibilities: -
Responsible to provide analytical support to FR&D for development, stability, clinical trial batch manufacturing, process evaluation batches and pilot batches.
Technical guidance to team members and supervising method development, part method validation and other analytical activities Successfully transferred validated methods to plant QC for the execution of submission.
Writing SOPs, method development, validation, method transfer protocols and reports.
Handling deficiencies in patient filing and launching of product.
Identification of Analytical labs for outsourcing and review of analysis.
Structural elucidation and Impurity profile study by LC-MS/MS, NMR and CHN analyzer. Experience in MRM, Pre-cursor ion & neutral-loss studies.
Macleod’s Pharmaceuticals Ltd.
Designation : Sr. Research Scientist
Duration : May 2007-May 2008
Responsibilities: -
Structural elucidation of API and Impurities with help of NMR, LCMS-MS and CHN analyzer.
Carryout Experiments like 1H, 13C, DEPT (45, 90, 135), APT, HMQC, NOE, COSY and NOESY.
Impurity profile study and routine infusion analysis on LC-MS-MS.
Lupin Research Park.
Designation : Research Associate
Duration : Feb2005-May 2007
Responsibilities: -
Method development for assay, related substances analysis for API and FDF by HPLC and GC.
Preparation of various method validation protocol and validation reports as per guidelines.
Successfully transferred validated analytical methods from R&D to QC.
Performed stability studies both accelerated and real time Analyzed stability samples by HPLC for assay, RS etc.
Structure elucidation of NCE molecules by NMR and LC-MS Spectroscopy.
Reaction monitoring on HPLC for Lab as well as large-scale batches.
Analysis of residual solvents (OVI) in bulk batches at plat by GC-HS.
Calibration of different instruments like HPLC, FTIR, UV-Visible spectrometer, KF moisture analyzer, Polarimeter.
Method development for dissolution profile studies to check in vivo comparison of brand product.
Sudarshan Chemicals Ltd.
Designation : Scientific officer
Duration : June2000-Feb2005
Responsibilities: -
Experience in analysis of wide range of raw materials, Intermediates and finished products.
Responsible for maintenance of 5S in the department in order to improve productivity and housekeeping of the department
Monthly environment checkup of the plant.
Worked on cost reduction of the department. Annual cost reduction 1.2 lack/annum.
EDUCATIONAL PROFILE
Master of Science, June 2003
N.M. Wadia College, Pune, India.
(University of Pune)
Major: Analytical Chemistry
Class: First (65.00 %)
Bachelor of Science, June 2000
H.V.Desai College, Pune, India.
(University of Pune)
Major: Analytical Chemistry
Class: First (64.00 %)
PERSONAL PROFILE
Date of birth - 30th May 1979
Gender - Male
Marital status - Married
Linguistic abilities - English, Hindi, Marathi and Gujarati
Nationality - Indian
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