Manager Technical

Deepak Ghate

M.Sc., Ph.D. (Analytical Chemistry)

Permanent Address Residential Address

A/P- Pahur, Near Water Supply Tank, Plot No. B-12/63, D-1 3rd

Kwaja Nagar, Tal-Jamner, Dist-Jalgaon Near Central Park, Kalyani,

Maharashtra-424205, India Dist-Nadia,West Bengal-741235

India

Mobile - +91-955*******

E Mail: *******@**********.***

*******@*****.***

OBJECTIVE

Seeking a challenging and responsible position in - Analytical fields where my expertise in quality systems like GLP, NABL also in chromatography, spectroscopy, and other wet analytical techniques will be utilized to enhance my growth with the company.

Extensive technical knowledge of regulatory requirements in terms of registration requirement of technical and formulated pesticides.

PRESENT OCCUPATION

Presently working with Krish Biotech Research Pvt. Ltd. as a Technical Manager to lead Study Director and Study Personnel for conducting Non-clinical Regulatory Five Batch Analysis Study, Analytical Method Development /Validation, Storage Stability, Environmental Fate and Metabolism Studies, Residue Analysis and Physico-Chemical Studies.

WORK EXPERIENCE

1.Technical Manager - Chemistry (17/05/2014 to till date)

Currently spearheading with Krish Biotech Research Pvt. Ltd., Kalyani, West Bengal as a Technical Manager. Krish Biotech Research Pvt. Ltd. is a R&D based Contract Research Organization promoted by the Krishi Rasayan Group a five decade old Chemicals Company with Manufacturing and Formulation units in India and export worldwide.

Job Profile at Krish Biotech Research

A.Technical

Develop new analytical methods for the analysis, characterization and identification of Agrochemicals, Pesticides, Intermediate chemicals, polymers, veterinary drugs, and pigments by using instruments like GC-MS, HPLC, GC, NMR, DSC, LC/MS/MS, FTIR and UV-Visible spectrophotometer.

Five Batch Analysis and Spectral Data for characterization of technical and formulated products as per OECD, SANCO and EPA Guidelines required for Indian and Foreign Product Registration including Brazilian requirement (ABNT).

Develop, prepare and approve GLP and Non-GLP Study Plan/Study plan amendment taking care of sponsor’s requirement, conducting the study, closing all study related QA audit reports and preparation of final reports and report amendment and their archival.

Preparation, revise, training and implementation of SOPs in order to perform GLP activities.

Prepare and revise study related formats as and when required.

Validation, calibration and maintenance of computerized system.

Documentation of Study Plan deviation and reporting its integrity on the results.

Develop analytical method and its validation for conducting recovery studies in different water media (reconstituted water, algal medium and tap water) vehicles like corn oil, DMSO and feed diets as to support toxicology studies.

Generating GLP Certificate of Analysis and Certificate of Characterization of technical and formulated test items as per sponsor’s requirement.

Preparation of action taken report to close non-compliances (NCs).

To monitor Inter Laboratory Comparison Program (ILC).

Evaluation and authorization of test report as a Technical Manager.

To monitor testing and re-testing of NABL scope product as per scope methodology.

B.Administrative

Manage team members with respect to work load sharing, distribution of activities for the smooth functioning of day to day activities in the department.

Review and approve analytical results.

Resolving study related queries with Sponsor and Regulatory Authorities from different countries.

Supervise to Study Directors in order to conduct the study in timely manner.

Delegate and monitor the responsibility for requirement, procurement, receipt, storage, utilization, disposal of the chemicals in the Department.

Delegate and monitor the responsibility for requirement, procurement, receipt, installation (IQ, OQ, and PQ), calibration, maintenance, etc. of the instruments in the Department.

Monitor procurement process for the reference standards, instruments, consumables, etc. necessary for the conduct of the studies.

Arrange from time to time, the training programs for improvements in the scientific aspect as well as quality system, for the conduct of studies and GLP compliance of the studies.

Keep a check on and inform the concerned for the adequate and timely availability of test items, reference items, instruments, chemicals, man power, etc. so that the studies do not get hampered.

Ensure that all the reagents, solutions and chemicals in the laboratory areas are labelled to indicate identity, concentration, storage requirements, preparation/opening date and expiration date etc., and maintenance of GLP/non GLP records/documents

Ensure that the principles of Good Laboratory Practices are compiled within the Department

2.Senior Research Officer (01/08/2012 to 30/04/2014)

Worked as a Sr. Research officer at Jai Research Foundation (JRF), Vapi, Gujarat India’s one of the leading Research Organization, endorsed for compliance with OECD principles of GLP by government of India.

Job Profile at Jai Research Foundation

Develop, prepare and approve GLP and Non-GLP Study Plan/Study plan amendment taking care of sponsor’s requirement, conducting the study, closing all study related QA audit reports and preparation of final reports and report amendment and their archival.

Preparation, revise, training and implementation of SOPs in order to perform GLP activities.

Prepare and revise study related formats as and when required.

Validation, calibration and maintenance of computerized system.

Documentation of Study Plan deviation and reporting its integrity on the results.

Develop new analytical methods for the analysis, characterization and identification of Agrochemicals, Pesticides, Intermediate chemicals, polymers, veterinary drugs, and pigments by using instruments like GC-MS, HPLC, GC, FTIR and UV-Visible spectrophotometer.

Five Batch Analysis and Spectral Data for characterization of technical and formulated products as per OECD, SANCO and EPA Guidelines required for Indian and Foreign Product Registration including Brazilian requirement (ABNT).

Develop analytical method and its validation for conducting recovery studies in different water media (reconstituted water, algal medium and tap water) vehicles like corn oil, DMSO and feed diets as to support toxicology studies.

Generating GLP Certificate of Analysis and Certificate of Characterization of technical and formulated test items as per sponsor’s requirement.

3.Officer (24/07/2004 to 25/07/2012)

Worked as an officer at Gharda Chemicals Ltd. (GCL), Dombivali, Maharashtra is approved for GLP compliance certification, by the National GLP Compliance Monitoring Authority (NGCMA), of the Govt. of India. GCL established in 1967, is a research-based company with four manufacturing units. The company has won several national awards for technical innovation in the chemical industry and has many firsts in the field of dyestuffs, pesticides, veterinary drugs and polymers.

Job Profile at Gharda Chemicals Ltd.

Develop, prepare and approve GLP and Non-GLP Study Plan/Study plan amendment taking care of sponsor’s requirement, conducting the study, closing all study related QA audit reports and preparation of final reports and report amendment and their archival.

Develop new analytical methods for the analysis, characterization and identification of Agrochemicals, Pesticides, Intermediate chemicals, polymers, veterinary drugs, and pigments by using instruments like NMR, LC-MS, GC-MS, HPLC, GC, FTIR and UV-Visible spectrophotometer.

Five Batch Analysis and Spectral Data for characterization of technical and formulated products as per OECD, SANCO and EPA Guidelines required for Indian and Foreign Product Registration including Brazilian requirement (ABNT).

Calibration of instruments like NMR, LC-MS, GC-MS, HPLC, GC, FTIR, UV- Visible spectrophotometer, AAS, EDXRF and KF titrator, etc.

Time to time update Logbooks for Study related activities and materials accordingly.

Generating GLP Certificate of Analysis and Certificate of Characterization of technical

Collection, storage, and disposal of waste generated in the facility.

Having experience in conducting following kind of Preclinical physical-chemical and analytical studies:

a.Five Batch Analysis

b.Pre-Screening with and without reference standards

c.Partition Coefficient: Shake Flask and HPLC methods

d.Water Solubility: Shake Flask and Column Elution Methods

e.Analytical Method Development and Validation for Technical and Formulation

f.Chemical Characterization

g.Vapour Pressure by Gas Saturation Method

h.Solvent Solubility: Shake Flask and Column Elution Methods

i.Hydrolysis as a Function of pH

j.Direct Photolysis

k.Residue Analysis

l.Storage Stability: Shelf Life, Accelerated Storage Stability at 54 C and Stability at 0 C, Test Item with Metal and Metal ion.

m.Container Content Compatibility

n.Analytical Test Report (ATR) as per BIS

o.Transport worthiness test

p.Other phys-chem like,

Wet Sieve Test and Dry Sieve Test, Suspensibility, Wettability, Dilution Stability, Dustiness, Persistent Foam, Pourability, Explodability by DSC, Emulsion Stability and Re-emulsification, Spontaneity of Dispersion, pH, Moisture Content, Acetone Insolubility, Surface Tension, Flash Point, Melting/Boiling Point, Acidity/Alkalinity, Density, Oxidation/Reduction properties, Appearance, Miscibility in hydrocarbon oil, etc.

Education

Qualification

Name of college/Institute

University

Year of passing

Ph.D. Chemistry

Gharda Chemicals Ltd., Dombivli (E)

Mumbai University

June 2010

M. Sc. Chemistry (Pesticides & Agrochemicals)

Dept. of Chemical Sciences

North Maharashtra University, Jalgaon

March 2003

B. Sc. Chemistry

A.C.S. College

North Maharashtra University, Jalgaon

March 2001

H.S.C.

New English School

Nasik Board

June 1999

S.S.C.

R.T. LeleHighschool

Nasik Board

June 1997

GLP Training/Seminar/Workshops attended

Attended various GLP training programme conducted by Dr. T.P. Suresh, Dr. Karambelkar at Gharda Chemicals Ltd., Dombivli, Maharashtra, India.

Attended in-house GLP/SOP Training Programme conducted by Dr. L.U. Sanghani at Jai Research Foundation, Vapi, Gujarat, India.

Attended in-house GLP Training Programme conducted by Dr.Dipak Agarwal at Krish Biotech Research Pvt. Ltd, Kalyani, West Bengal, India.

Attended Symposium on "Evolution of Gas Chromatography in India-Past, Present and Future" organized by Chromatographic Society of India and Chemistry Group, BARC during November 23-24, 2012 at BARC Training School, Anushaktinagar, Mumbai.

Expertise and Skills

Knowledge to set up a new Laboratory and preparation of related documents for running of Laboratory for its intended purposes.

Good reasoning and communication skills, Good inter personal relationships, Ability to work in different environments, Ability to work as a leader of a team by working with the team.

Provides clear, concise written and verbal communication with sponsor’s from different countries.

Having experience of facing audits of NGCMA and Netherland GLP Monitoring authority, NABL and CIBRC which includes their extensive interviews.

Achievement

It is worthwhile to mention here that I am the first student who got doctorate degree from Gharda Chemicals Ltd., Dombivali (E) which is a recognized institute by Mumbai University for Ph.D. and M.Sc. in chemistry (by research). Research was carried out under the guidance of one of the pioneers in chromatography, Late Dr. P. S. Ramanathan.

Given presentation to Test Facility Management, Study Directors, Study Personnel, Quality Assurance Unit, Archivists and Test Item Control Officers on Five Batch Analysis and Physical-Chemical testing for the declaration of Study Director and cleared it successfully.

Certificate of Appreciation for the contribution towards the achievement of the OECD GLP certificate conferred upon Krish Biotech Research Pvt. Ltd. On 8th June, 2015 by the NGCMA, New Delhi.

Successfully faced NABL audits as a Technical Manager and got the accreditation for the same.

Successfully faced CIBRC audit and got the approval for various tests like physical – chemical testing, residue analysis and transport worthiness test.

PersonalDetail

Name : Dr. Deepak Bhagwat Ghate

Age : 36 years

Date of birth : 1st June 1980.

Gender : Male

Marital status : Married

Alternat E-mail : **********@**********.***

Current CTC : 11.5 Lac/Annum

Expected CTC : Negotiable

Job Location : Kalyani

Declaration

I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.

Place: Kalyani

Date: Dr. Deepak Ghate

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