DR. Chinmoy Ghosh
Principal Scientist (Analytical & Bioanalytical Development)
Ahmedabad,GJ
Summary
A competent Management Professional with over 18 years of rich experience in analytical development. Specialist with experience in experimental research and data analysis. Detail-oriented and methodical professional successful in developing in-depth research projects. Reliable team player with excellent communication and problem-solving skills. Abilities in harmoniously managing day to day operations with a talent for GLP, Quality Assurance, QMS Implementation & Compliance in line with industry best practices. Exceptional communicator with an uncompromising commitment to performance excellence and an ardent bias for action.
Overview
9
9
years of post-secondary education
18
18
years of professional experience
Work History
Principal Research Scientist
Zydus Cadila
Moraiya, Ahmedabad, Gujarat
03.2018 - Current
- Performed preliminary and exploratory data analysis for Nitrosamine impurities studies on already submitted products to agency.
- Completed all projects by deadline and under budget for company-wide initiatives.
- Conducted many studies on drug-excipient compatibility study and related data analysis and role of each in drug development.
- Documented and reported test results after making graphical solutions and representations.
- Conducted studies to develop responsible strategies for impurity evaluation of all projects to get first cycle approval from the agency.
- Recognized abnormal test results and devised corrective actions to retain accurate and valid results.
Senior Research Scientist
Zydus Cadila
Moraiya, Ahmedabad, Gujarat
03.2013 - 03.2018
- Handling a team of 8-12 scientists
- Project handling for US and Europe markets
- Having a supervisory ability, exposure of planning, execution of work based on priority requirement
- Having an ability to run the department independently and can able for decision making based on priority requirement
- Deficiency handling from US and EU agencies with stipulated time frame
- Having an experience of handling of Investigative analysis for Out Of Specification and Out Of Trend results and documentation for the same
- Empowering the juniors
Senior Research Executive
Aristo Pharmaceuticals Limited
Mnadideep, Bhopal, Madhya Pradesh
09.2012 - 03.2013
- Led research team of 5-6 scientists on new products and successfully met all key milestones
- Manage resources and constraints to ensure timely completion of deliverables
- Communicate with senior project team on regular basis on the developmental risks, status and constraints
- Communicate with interdepartmental heads on routine basis to ensure smooth information exchange
- Set up the processes within the method development group and stability group
- Implement approach to address the risks earlier in the program
- Manage method development, method transfers activities and stability studies as per the schedule
- Monitor and review project activities and resource utilization within the group
- Providing technical inputs during method development and validation of analytical methods as per regulatory guidelines
- Guiding during Dissolution profiling, FD studies, RS method development of pharmaceutical intermediate, finished dosage forms and raw materials
- Played a stellar role in technology transfer to other locations
- Ensured the compliance with the standards of various national and international regulatory bodies
Research Scientist-II
Cadila Pharmaceutical Limited
Dholka, Ahmedabad, Gujarat
04.2005 - 08.2012
- Played a stellar role in handling the queries of the sponsors
- Holds the distinction of completing the development & validation of analytical methods of some of the very critical molecules like Clonodine, Alverine with its metabolite, MiDASMA (NCE), Prothionamide & its metabolite, Ethionamide & its metabolite, EPA & DHA, UDCA & GDCA, Curcumin, Tacrolimus, Atorvastatin & its metabolites, Masellamine, Acomprasate, etc.
- Ensured the compliance with the standards of various national and international regulatory bodies like:
o WHO-Geneva (2 times)
o TGA
o MHRA
o ANVISA (2 times)
o DCGI (3 times)
o USFDA.
Instruments Handled:
º LC\MS\MS:
o API - 3000 / 4000 from AB Sciex
o Quattre Premiur XE from Waters
º HPLC/UPLC:
o Acquity UPLC (Empower2)
o WATERS – 2695 (Millennium32 / Empower2)
o DIONEX (Chromellion)
o AGILENT 1000 Series (H.P. Chemstation)
o SHIMADZU (LC Solutions, Class VP, Class M10, CSW)
o PERKIN ELMER (Total chrome navigator)
Others:
o UV-VIS spectrometer
o GC
o FT-IR
o DSC
o Dissolution apparatus, etc.
Quality Control Chemist
Aristo Pharmaceuticals Limited
Mandideep, Bhopal, Madhya Pradesh
07.2003 - 03.2005
- Prepared and standardized test equipment, test solutions and reagents to enable successful testing completion.
- Carefully handled lab samples and disposed of waste by adhering to safety protocols.
- Collaborated with laboratory technicians, production personnel and customers to improve product quality and functionality.
- Operated specialized scientific equipment and performed complex procedures to execute high-level analytical testing tasks.
- Performed standard and proprietary physical testing and chemical analysis of raw chemical materials and finished products.
- Developed final batch release reports based on testing observations.
- Generated technical reports and other documentation to record analytical test results and conclusions.
- Calibrated analytical equipment on regular basis and documented readings and adjustments to improve equipment accuracy.
- Monitored consumable laboratory supplies and replenished inventory to enable timely completion of testing activities.
- Performed preventive maintenance and calibrated equipment to keep laboratory in compliance with established standards.
- Modified and adapted standard methods and procedures to solve analytical problems.
Education
Bachelor of Science - Industrial Chemistry
Ramakrishna Mission Vidyamandira
Calcutta Univ, Belur Math, Howrah; West Bengal 01.1997 - 01.2000
Master of Science - Industrial Chemistry
Dr. Baba Saheb Ambedkar Marathwada University
Aurangabad, Maharashtra 01.2002 - 01.2003
PGDCA (DOEAC-A Level) -
DOEAC
Calcutta 01.2000 - 01.2001
Executive Program in Business Management -
Indian Institute of Management, Calcutta (IIM-C)
Joka, Calcutta 01.2011 - 01.2012
Ph.D. - Analytical Chemistry
Jiwaji University
Gwalior, Madhya Pradesh 01.2009 - 01.2012
Skills
Overview of analytical activities
undefinedCarrier Facts
- Demonstrated excellence in attaining more than 15 international publications in reputed International journals
- Received the enlistment in Marquis Who’s Who 2011 edition under the category “Significant Contribution in the Field of Analytical Chemistry”
- Obtained the Lifetime Membership in Chromatographic Society of India
- Lifetime member of American Chemical Society
- Recognized as the youngest Editorial Board Member in an International Journal from Cadila Pharmaceuticals Limited
Areas of Excellence
Research & Development:
- Spearheading the R & D Operations & modification of existing ones, based on market feedback & trends
- Conducting detailed studies for analytical & bioanalytical methods in plasma, blood, kidney, lever, heart, pancreas, etc.
- Facilitating Method Development and validation i.e. rigorous testing of the methods to ensure that they are precise, accurate, reproducible, "fool-proof" and specific to the product, etc
- Hands on experience in the development and validation of analytical methods for the new products/ molecules
Process improvement:
- Analyzing various processes / applications and recommending process modifications and equipment calibrations to enhance operational efficiency
- Handling capacity enhancement and cost reduction initiatives and ensuring escalation of plant productivity and introducing process controls and consumption norms to avoid process wastages
Client servicing:
- Providing effective resolution to customer queries and improving relationships with the customer by anticipating customer future requirements, thereby ensuring a positive customer experience
- Sustaining healthy relations with clients, providing them advisory support for effective research and development solutions
Publications
Manuscript:
1. Chinmoy Ghosh, V. Jha, C. Patra, R. Ahir, B. S. Chakraborty; Simultaneous determination of Docosahexanoic Acid and Eicosapentanoic Acid by ESI-LC-MS/MS from Human Plasma: Application to Bio-analysis; Journal of Liquid Chromatography and Related Technologies; DOI:10.1080/10826076.2011.627603.
2. Chinmoy Ghosh; Green Bioanalysis: Some Innovative Ideas towards Green Analytical Techniques; Bioanalysis; Vol. 4 (11); 2012; 1377-1391.
3. Chinmoy Ghosh, C. P. Shinde, B. S. Chakraborty; Influence of ionization source design on matrix effects during LC-ESI-MS/MS analysis; Journal of Chromatography B; Vol. 893-894; 2012; 193-200.
4. Chinmoy Ghosh, I. Jain, C. P. Shinde, B. S. Chakraborty; A Rapid and Most Sensitive Liquid Chromatography / Tandem Mass Spectrometry Method for Simultaneous Determination of Enalapril and its Major Metabolite Enalaprilat, in Human Plasma: Application to a Pharmacokinetic and Bioequivalence Study; Drug Testing and Analysis; Vol. 4 (2); 2012; 94-103. [Citation: 01]
5. Chinmoy Ghosh, A. Upadhyay, S. Kasodekar, V. Gupta, K. Sanghvi, K. Bhattarcharya, B. Chakraborty; Rapid determination of isoniazid in human plasma by HPLC-UV and its application to a bioequivalence study; Global Journal of Analytical Chemistry; Vol. 3(4); 2012; 1-7.
6. Chinmoy Ghosh, A. Upadhyay, A. Singh, S. Bahadur, P. Jain, B. S. Chakraborty; Selective, Sensitive, Precise and Accurate Ultra performance Liquid Chromatography Method with UV Detection for Determination of Aspirin and its Metabolite in Human Plasma; Journal of Liquid Chromatography & Related Technologies; Vol. 34(19); 2011; 2326-2338.
7. Chinmoy Ghosh, V. Jha, C. P. Shinde, B. S. Chakraborty; LC-MS Analysis of Acamprosate from Human Plasma: Pharmacokinetic Application; Drug Testing and Analysis. Vol. 3; 2011; 735-742.
8. Chinmoy Ghosh, S. Gaur, C. P. Shinde, B. Chakraborty; A Systematic Approach to Overcome the Matrix Effect during LC-ESI-MS/MS Analysis by different Sample Extraction Techniques; Journal of Bioequivalence and Bioavailability; Vol. 3(6); 2011; 122-127. [Citation: 01]
9. Chinmoy Ghosh, I. Jain, S. Gaur, N. Patel, A. Upadhyay, B. S. Chakraborty; Simultaneous estimation of Atorvastatin and its two metabolites from Human Plasma by LC-ESI-MS/MS; Drug Testing and Analysis; Vol. 3; 2011; 352-362.
10. Chinmoy Ghosh, S. Gaur, A. Singh, C. P. Shinde, B. Chakraborty; Estimation of Nevirapine from Human Plasma by LC-ESI-MS/MS: a Pharmacokinetic Application; Journal of Bioequivalence and Bioavailability; Vol. 3(1); 2011; 20-25. [Citation: 04]
11. Chinmoy Ghosh, I. Jain, C. P. Shinde, B. S. Chakraborty; Ionization Polarity as a Cause of Matrix Effects, its Removal and Estimation in ESI-LC-MS/MS Bio-analysis; Journal of Analytical & Bioanalytical Techniques; Vol. 1(2); 2010; 106. [Citation: 03]
12. G. R. Shah, Chinmoy Ghosh, B. T. Thaker; Determination of pregabalin in human plasma by electrospray ionization mass spectrometry; Journal of Advanced Pharmaceutical Technology and Research; Vol. 1(3); 2010; 354 – 357.
13. Chinmoy Ghosh, V. Jha, R. Ahir, S. Shah, C.P. Shinde, B. S. Chakraborty; A rapid and most sensitive liquid chromatography/tandemmass spectrometry method for simultaneous determination of alverine and its major metabolite, para hydroxy alverine, in human plasma: application to a pharmacokinetic and bioequivalence study; Drug Testing and Analysis; Vol. 2(6); 2010; 84–291. [Citation: 06]
14. Patel, T. Shah; G. Shah, V. Jha, Chinmoy Ghosh, J. Desai, B. Khamar, B. S. Chakraborty; Preservation of Bioavailability of Ingredients and Lack of Drug-Drug Interactions in a Novel Five-Ingredient Polypill (Polycap(TM)): A Five-Arm Phase I Crossover Trial in Healthy Volunteers; American Journal of Cardiovascular Drugs; Vol. 10(2); 2010; 95-103. [Citation: 07]
15. G. N. Sharma, B. S. Chakraborty, J. Sanadya, U. S. Baghel, Chinmoy Ghosh, M. Singhal; Bio-analytical Estimation of Losartan and Losartan Carboxylic acid Concentrations in Human Plasma by Using LC-MS/MS; International Journal of Pharmaceutical Quality Assurance; Vol. 2(1); 2010; 13-18.
16. Chinmoy Ghosh, R. P. Singh, S. Inamdar, M. Mote, B. S. Chakraborty; Sensitive, Selective, Precise and Accurate LC–MS Method for Determination of Clonidine in Human Plasma; Chromatographia; Vol. 69 (11-12); 2009; 1227-1232. [Citation: 06]
Abstract:
º Chinmoy Ghosh; Matrix Effects, a Major Concern During LC-MS/MS Bio-analysis; Pharmaceutica Analytica Acta; Vol. S1; 2010.
º M. Mote, S. Inamdar, Chinmoy Ghosh, B. Chakraborty; A Sensitive, Selective, Precise and Accurate LC-MS/MS Method for Determination of Clonidine in Human Plasma; The American Association of Pharmaceutical Scientists Journal; Vol. 9 (S2); 2007.
Work Availability
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Accomplishments
- Holds the distinction of being invited as a Speaker for:
1. International Conference and Exhibition on ‘Analytical and
Bioanalytical Techniques: Pharmaceutical R & D summit'
Hyderabad, India. November 01 - 03, 2010 on the topic Matrix
Effects, A Major Concern during LC-MS/MS Bio-Analysis
2. National conference and exhibition on ‘Innovation in
Pharmaceutical Industry: From Drug Development to Distribution’,
Ahmedabad, India. January 28-29, 2012 on the topic Matrix
Effects & Drug Discovery and Development-Two Faces of a Coin.
- Associated as a reviewer for the following journals:
1. Journal of Liquid Chromatography and Related Technologies
2. Journal of Advanced Pharmaceutical Technology and Research
3. Global Journal of Analytical Chemistry
4. Journal of Analytical and Bioanalytical Technologies
5. Journal of Bioequivalence and Bioavailability
Timeline
Principal Research Scientist
Zydus Cadila
03.2018 - Current
Senior Research Scientist
Zydus Cadila
03.2013 - 03.2018
Senior Research Executive
Aristo Pharmaceuticals Limited
09.2012 - 03.2013
Executive Program in Business Management -
Indian Institute of Management, Calcutta (IIM-C)
01.2011 - 01.2012
Ph.D. - Analytical Chemistry
Jiwaji University
01.2009 - 01.2012
Research Scientist-II
Cadila Pharmaceutical Limited
04.2005 - 08.2012
Quality Control Chemist
Aristo Pharmaceuticals Limited
07.2003 - 03.2005
Master of Science - Industrial Chemistry
Dr. Baba Saheb Ambedkar Marathwada University
01.2002 - 01.2003
PGDCA (DOEAC-A Level) -
DOEAC
01.2000 - 01.2001
Bachelor of Science - Industrial Chemistry
Ramakrishna Mission Vidyamandira
01.1997 - 01.2000
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