About the company

AGS Pharma Consulting, founded by Dr. Gautam Samanta, is one of the “Top 10 biotech consultants-2025,” featured by India Pharma Outlook (October), and recognized by The Enterprise World (2026) as “The Architect of Consistency in Global Pharma Outcomes”.

The firm specializes in Quality by Design (QbD), Design of Experiments (DoE), Process Analytical Technology (PAT), Quality Risk Management (QRM), API process scale-up,Statistical Process Control (SPC), and driving improvements in cost, quality, and operational efficiency.

AGS Pharma Consulting offers end-to-end consulting, training, and implementation services across industries, including pharmaceuticals (API and formulations), biotechnology, specialty and fine chemicals, and food processing.

Dr. Gautam Samanta, Founder and Director

Consultant: Cipla Ltd, Jubilant Ingrevia, Aarti Industries, Apitoria Pharma

Dr. Gautam Samanta, the founder of AGS Pharma Consulting, is an innovative and results-driven Six Sigma-certified professional with over 30 years of experience in both academic and pharmaceutical research and development. He has a strong track record in developing robust drug substances and drug products and has expertise in analytical methods through the Quality by Design (QbD) approach. Dr. Samanta is highly skilled in scaling up APIs and managing technology transfers, demonstrating a remarkable ability to reduce costs while enhancing the quality of high-value commercial APIs. He has successfully implemented Process Analytical Technology (PAT) on a commercial scale, achieving consistently high-quality pharmaceutical products and reducing batch failure rates. Dr. Samanta has also published over fifty articles in prestigious peer-reviewed journals, including Nature, and authored seven book chapters and holds three process patents

  • Founder of AGS Pharma Consulting, specializing in training and consulting on Quality by Design (QbD), Design of Experiments (DoE), and Process Analytical Technology (PAT), Quality Risk Management (QRM), andStatistical Process Control (SPC) and Cost, Quality, and Efficiency Improvement, and Process Scale-up (API).
  • Consultant, Cipla Ltd., Mumbai.
  • Trained successfully over 600 R&D scientists, engineers, and quality professional from leading pharmaceutical and specialty companies including Sun Pharma, Cipla, Torrent Pharmaceuticals, Apitoria Pharma (A unit of Aurobindo Pharma), Aurigene Pharmaceutical Services, Neuland Laboratories, Alivus Life Sciences, and others.
  • Pioneered innovative approaches in product development using QbD, PAT, and lab automation for drug substances and drug products.
  • Supported over 150 analytical methods, 110 APIs, 100 formulations, and 30 cost and quality improvement initiatives through the Quality by Design (QbD) approach.
  • Authored more than ten articles in peer-reviewed journals on the implementation of QbD, DoE, and PAT in API, formulation, and analytical method development.
  • Contributed significantly as a leader over 17 years in the pharmaceutical industry (at Cipla and Dr. Reddy’s Labs), focusing on process development with the QbD approach and API scale-up.
  • Honored with the Chairman Excellence Award at Dr. Reddy’s Labs in 2010 and 2012 for exceptional achievements in laboratory automation and Quality by Design.
  • Invited as an advisor to the International Atomic Energy Agency (IAEA) in Vienna, Austria, to discuss “Exposure to Toxic Elements During Infancy”. 2009
  • Invited participant in the U.S. International Visitor Program on Global Climate Change.1999
  • Earned a Ph.D. from Jadavpur University.
  • Conducted postdoctoral research at the National Institute of Health and Environmental Sciences in Japan and Texas Tech University in the USA.
  • Served as a Research Assistant Professor at the University of Houston, USA.
  • Dr. Samanta has also published over fifty articles in prestigious peer-reviewed journals, including Nature, and authored seven book chapters and holds three process patents, with more than 50 papers presented at national and international symposia on QbD, DoE, and PAT.
  • Inventor of three patents related to removal technologies.
  1. Khanolkar A., Pawale P., Thorat V., Patil B., Samanta G., “NIR spectroscopy for determination of moisture content in lyophilized formulation”, Journal of Near Infrared Spectroscopy, 32(1-2), 18-28, 2024
  2. Tol T., Mhamunkar S., Tawde H., Desai Y., Dharurkar R., Samanta G., “Prediction of shelf-life during the development phase of drug substance and drug product using accelerated stability assessment program.”, Current Indian Science, 1, 1-7, 2023
  3. Khanolkar A, Patil B, Thorat V, Samanta G., “Towards real-time release of blends tablets using NIR and Raman spectroscopy at commercial scales,” Pharmaceutical Development and Technology, 28 (3-4), 265-276, 2023.
  4. Kandula V. R, Shaikh L, Samanta G., “Utilization of Quality by Design, Kinetic Modeling, and Computational Fluid Dynamics for Process Optimization and Scale-up, “Organic Process Research and Development, 27(5), 875-889, 2023.
  5. Khanolkar A., Patil B., Thorat V., Samanta G.,” Development of inline near-infrared spectroscopy method for real-time monitoring of blend uniformity of direct compression and granulation-based products at commercial scales.” AAPS PharmSciTech, 23, 235, 2022.
  6. Tol T., Tawde H., Gorad S., Jagdale A., Kulkarni A., Kasbale A, Desai A, Samanta G.,” Optimization of a liquid chromatography method for the analysis of related substances in daclatasvir tablets using design of experiments integrated with the steepest ascent method and Monte Carlo simulation.” Journal of Pharmaceutical and Biomedical Analyses, 178, 112943, 2020
    .
  7. Khanolkar A., Thorat V., Raut P., Samanta G., “Application of quality by design: Development to the manufacturing of diclofenac gel.” AAPS PharmSciTech, 18(7), 27-54-2763, 2017.
  8. Chakraborti D., Rahman M.M., Chatterjee A., Das D., Das B., Nayak B., Pal A., Chowdhury U.K., Ahmed S., Biswas B.K., Sengupta M.K., Lodh D., Samanta G., Chakraborty S., Roy M.M., Dutta R.N., SahaC., Mukherjee S.C., Pati S., Kar P.B., Mukherjee A., Kumar M., “Groundwater arsenic contamination and its health effects in India.” Hydrogeology Journal, 25, 1165-1181, 2017.
  9. Tol T., Kadam N., Raotole N., Desai, A., Samanta G., “A simultaneous determination of related substances by high-performance liquid chromatography in a drug product formulated in a combination of three drug substances using quality by design approach,” Journal of Chromatography A, 1432, 26-38, 2016.
  10. Samanta G. “Implementation of QbD in API development,” Pharma Times, 46 (8), 44 -47, 2014.
  11. Murthy V. M., Krishnaiah C., Jyothirmayi K., Srinivas K., Mukkanti K., Kumar K., Samanta G. “Enantioseparation of palonosetron hydrochloride and its related enantiomeric impurities by computer simulation and validation,” American Journal of Analytical Chemistry, 2, 437-446, 2011.
  12. Suchitra Ch., Maitra K., Raut D., Shilpa L., Dodla H., Ravindra Y.K., Bhattacharya A., Suryanarayana M.V., and Samanta G., “Reaction of finasteride intermediate with benzeneseleninic anhydride: an in-depth study,” Industrial & Engineering Chemistry Research, 47, 9201-9205, 2008.
  13. Chakraborti D., Rahman M.M., Chatterjee A., Das D., Das B., Nayak B., Pal A., Chowdhury U.K., Ahmed S., Biswas B.K., Sengupta M.K., Lodh D., Samanta G., Chakraborty S., Roy M.M., Dutta R.N., SahaC., Mukherjee S.C., Pati S., Kar P.B., “Fate of over 480 million inhabitants living in arsenic and fluoride endemic Indian districts: Magnitude, health, socio-economic effects and mitigation approaches.” Journal of Trace Elements in Medicine and Biology, 38, 35-45, 2016
  14. Lakshmanan D., Clifford D. A., Samanta G., “Comparative study of arsenic removal by iron using electrocoagulation and chemical coagulation.” Water Research, 19(44), 5641-5652, 2010.
  15. Lakshmanan D., Clifford D. A., Samanta G., “Ferrous and Ferric ion generation during iron electrocoagulation.” Environmental Science & Technology, 43(10, 3853-3859, 2009.
  16. Lakshmanan D., Clifford, D., and Samanta G., “Arsenic removal by coagulation with aluminum, iron, titanium, and zirconium,” Journal American Water Works Association, 100(2), 76-88, 2008.
  17. Samanta G., Das D., Mandal B. K., Roy Chowdhury T., Chakraborti D., Pal A., Ahamad S., “Arsenic in the breast milk of lactating women in arsenic-affected areas of West Bengal, India and its effect on infants.” Journal of Environmental Science and Health, Part A, 42(12), 1815-1825, 2007.
  18. Samanta G. and Clifford D., “Influence of sulfide (S2-) on preservation and speciation of arsenic in drinking water,” Chemosphere, 65, 847-853, 2006.
  19. Samanta G. and Clifford D., “Preservation and field-preservation of inorganic arsenic species in groundwater,” Water Quality Research Journal of Canada, 41(2), 107-116, 2006.
  20. Karori S., Clifford D. A., Ghurye G., and Samanta G., “Development of a field speciation method for inorganic arsenic species in groundwater,” Journal AWWA, 98(5), 128-141, 2006.
  21. Samanta G., Clifford D. A., Samanta G., “Preservation of inorganic arsenic species in groundwater.” Environmental Science & Technology, 29(22), 8877-8882, 2005.
  22. Samanta G., Sharma R. K., Roy Chowdhury T., and Chakraborti, D., “Arsenic and other elements in hair, nails, and skin scales of arsenic victims from an arsenic affected area of West Bengal, India,” The Science of the Total Environment, 326, 33-47, 2004.
  23. Al-Horr R., Samanta, G., and Dasgupta P. K., “A continuous analyzer for soluble anionic constituents and ammonium in atmospheric particulate matter,” Environmental Science & Technology, 37(24), 5711-5720, 2003.
  24. Samanta G., Zhang S., and Dasgupta P. K., “An automated sequential injection analysis system for the determination of trace endotoxin levels in the water,” PDA Journal of Pharmaceutical Science and Technology, 57(1), 12-24, 2003.
  25. Samanta G., Boring C. B., and. Dasgupta P. K., “Continuous automated measurement of hexavalent chromium in airborne particulate matter,” Analytical Chemistry, 73, 2034-2040, 2001.
  26. Oshikawa S., Greater A., Chongsuvivatwong V., Piampongsam T., Chakraborti D., Samanta G., Mandal B. K, Hotta, N., Kojo, Y., and Hironaka, H., “Long-term changes in the severity of arsenical skin lesions following intervention to reduce arsenic exposure,” Environmental Sciences, 8, 435-448, 2001.
  27. Samanta G., Chowdhury U.K., Mondal B. K., Chakraborti D., Chandra N., Tokunaga H., and Ando M., “Speciation of arsenic compounds in urine samples by HPLC-ICP-MS,” Microchemical Journal, 65, 113-127, 2000.
  28. Chowdhury U. K., Biswas B. K., Roy Chowdhury T., Samanta G., Mandal B. K., Basu G. K., Chanda C. R., Lodh D., Saha K. C., Mukherjee S. K., Roy S., Kabir S., Quamruzzaman Q and Chakraborti D., “Groundwater arsenic contamination in Bangladesh and West Bengal-India,” Environmental Health Perspectives, 108, 393-397, 2000.
  29. Chakraborti D., Chanda C. R., Samanta G., Chowdhury U. K., Mukherjee S. C., Pal A. B., Sharma B., Mahapatra K. J., Ahmed H. A., Sing B., “Fluorosis in Assam, India,” Current Science, 78, 1421-1423, 2000.
  30. Samanta G., Roy Chowdhury T., Mandal B. K., Biswas B. K., Chowdhury U. K., Basu G. K., Chanda C. R., Lodh D., and Chakraborti D., “Flow injection hydride generation atomic absorption spectrometry for the determination of arsenic in water and biological samples from arsenic-affected districts of West Bengal, India, and Bangladesh,” Microchemical Journal, 62, 174-191,1999.
  31. Roy Chowdhury T., Basu G. K., Mandal B. K., Biswas B. K., Samanta G., Chowdhury U. K., Chanda C. R., Lodh D., Roy S. L., Saha K. C., Roy S., Kabir S., Quamruzzaman Q and Chakraborti D., “Arsenic poisoning in the Ganges delta,” Nature, 401, 545-546, 1999.
  32. Chakraborti D., Mandal B. K., Dhar R. K., Biswas B., Samanta G., Saha K. C., “Groundwater arsenic calamity in West Bengal, India, and Bangladesh,” Indian Journal of Environmental Protection, 19, 565-566, 1999
  33. Chakraborti D., Biswas B. K., Basu G. K., Chowdhury U. K., Roy Chowdhury T., Lodh D., Chanda C. R., Mandal B. K., Samanta G., Chakraborti A. K., Rahaman M. M, Roy S., Kabir S., Ahmed B., Das R., Salim M., and Quamruzzaman Q.; “Possible arsenic contamination free groundwater source in Bangladesh,” Journal of Surface Science and Technology, 15, 179-187, 1999.
  34. Chakraborti D., Samanta G., Mandal B. K., Roy Chowdhury T., Chanda C. R., Biswas B. K., Dhar R. K., Basu G. K., and Saha K. C., “Calcutta’s industrial pollution: Groundwater arsenic contamination in a residential area and sufferings of people due to industrial effluent discharge- an eight-year study report,” Current Science, 74(4), 346-355, 1998.
  35. Chattopadhyay G., Samanta G., Chatterjee S., and Chakraborti D., “Determination of particulate phase polycyclic aromatic hydrocarbons in ambient air of Calcutta for three years during winter,” Environmental Technology, 19, 873-882, 1998.
  36. Samanta G., Das D., Chattopadhyay G., Mandal B. K., Roy Chowdhury T., Chowdhury P. P., Chanda C. R., Benerjee P., Lodh D., and Chakraborti D., “Air pollution in Calcutta during winter- A three-year study,” Current Science, 75(2), 123-138, 1998.
  37. Mandal B. K., Roy Chowdhury T., Samanta G., Mukherjee D. P., Chanda C. R., Saha K. C., and Chakraborti D., “Impact of safe water for drinking and cooking on five arsenic-affected families for 2 years in West Bengal, India,” The Science of the Total Environment, 218, 185-201, 1998.
  38. Biswas B. K., Dhar R.K., Samanta G., Mandal B. K., Chakraborti D., Faruk I., Islam K. S., Chowdhury M. M., Islam A., and Roy S., “Detailed study report of Samta, one of the arsenic-affected villages of Jessore district, Bangladesh,” Current Science, 74(2), 134-145, 1998.
  39. Chattopadhyay G., Samanta G., Chatterjee S., and Chakraborti D., “Determination of benzene, toluene, and xylene in ambient air of Calcutta for three years during winter, Environmental Technology,” 18, 211-218, 1997.
  40. Dhar R. K., Biswas B. K., Samanta G., Mandal B. K, Chakraborti D. Roy S., Jafar A., Islam A., Ara G., Kabir S., Khan A.W., Ahmed S.A., and Hadi S.A., “Groundwater arsenic calamity in Bangladesh,” Current Science, 73(1), 48-59, 1997.
  41. Mandal B. K., Roy Chowdhury T., Samanta G., Basu G. K., Chowdhury P.P., Chanda C. R., Karan N. K., Lodh D., Dhar R. K., Tamili D. K., Das, D., Saha K.C. and Chakraborti D., “Chronic arsenic toxicity in West Bengal,” Current Science, 70(2), 114-117, 1997.
  42. Samanta G. and Chakraborti D., “Flow injection atomic absorption spectrometry for standardization of arsenic, lead, and mercury in environmental and biological standard reference materials,” Fresenius Journal of Analytical Chemistry, 357, 827-832, 1997.
  43. Samanta G. and Chakraborti D., “Flow injection hydride generation atomic absorption spectrometry (FI-HG- AAS) and spectrophotometric methods for determination of lead in environmental samples,” Environmental Technology, 17, 1327-1337, 1996.
  44. Das D., Samanta G., Mandal B.K., Roy Chowdhury T., Chanda C. R., Chowdhury P.P., Basu G.K., and Chakraborti D., “Arsenic in groundwater in six districts of West Bengal, India,” Environmental Geochemistry & Health, 18(1), 5-15,1996.
  45. Mandal B.K., Roy Chowdhury T., Samanta G., Basu G. K., Chowdhury P.P., Chanda C. R., Karan N. K., Lodh D., Dhar R. K., Tamili D. K., Das D., Saha K.C. and Chakraborti D., “Arsenic in groundwater in seven districts of West Bengal, India: the biggest calamity in the world,” Current Science, 70(11), 976-986, 1996.
  46. Samanta G., Chatterjee A., Das D., Samanta G., Chowdhury P.P., Chanda C. R., and Chakraborti D., “Calcutta pollution: Part V. Lead and other heavy metal contamination in a residential area from a factory producing lead- ingots and lead-alloys,” Environmental Technology, 16, 223-231, 1995.
  47. Das D., Chatterjee A., Mandal B.K., Samanta G., Chakraborti D. and Chanda, B., “Arsenic in groundwater in six districts of West Bengal, India: the biggest arsenic calamity in the world, Part 2. Arsenic concentration in drinking water, hair, nails, urine, skin-scale and liver tissue (Biopsy) of the affected people,” Analyst, 120, 917-924, 1995.
  48. Chatterjee A., Das D., Mandal B.K., Roy Chowdhury T., Samanta G., and Chakraborti D., “Arsenic in groundwater in six districts of West Bengal, India: the biggest arsenic calamity in the world, Part I. Arsenic species in drinking water and urine of the affected people,” Analyst, 120, 643-650, 1995.
  49. Das D., Chatterjee A., Samanta G., Mandal B., Roy Chowdhury T., Samanta G., Chowdhury P.P., Chanda C., Basu G., Lodh D., Nandi S., Chakraborty T., Mandal S., Bhattacharya S.M. and Chakraborty D., “Arsenic contamination in groundwater in six districts of West Bengal, India: the biggest arsenic calamity in the world,” Analyst, 119, 168N-170N, 1994.
  50. Das D., Chatterjee A., Samanta G., and Chakraborti D., “Preliminary estimation of tetraalkyllead compounds (TAL) in Calcutta city air,” Chemical and Environmental Research, 1(3), 279-287, 1992.

 

  1. Chowdhury U. K., Rahman M. M., Samanta G, Biswas B. K., Basu G. K., Chanda,C. R., Saha, K. C, Lodh D., Roy, S., Quamruzzaman, Q. and Chakraborti D., “Groundwater arsenic calamity in West Bengal-India and Bangladesh” in Bioavailability, Toxicity and Risk Relationships in Ecosystems, Naidu R., Gupta V. V. S. R., Rogers S, Kookana R. S, Bolan N. S and Adriano D. C. (Eds), Science Publishers, Inc., Enfield (NH), USA, Polymouth, U. K., 291-329, 2003.
  2. Chowdhury U. K., Biswas B. K., Roy Chowdhury T., Mandal B. K., Samanta G., Basu G. K., Chanda C. R., Lodh D., Saha K.C., Chakraborti D., Mukherjee S. C., Roy S., Kabir S., and Quamruzzaman Q., “Arsenic groundwater contamination and sufferings of people in West Bengal-India and Bangladesh” in Trace Elements in Man and Animal, Roussel, A. M., Anderson, R. A, Favier, A. E. (Eds), Kluwer Academic/Plenum Publishing Corporation, New York, 645-650, 2001.
  3. Chowdhury U. K., Biswas B. K., Dhar R.K., Samanta G., Mandal B.K., Roy Chowdhury T., Roy S., Kabir S., and Chakraborti D., “Groundwater arsenic contamination and sufferings of people in Bangladesh” in Arsenic Exposure and Health Effects, W. R. Chappell, W.R., Abernathy, C. O., and Calderon R. L. (Eds), Elsevier, Amsterdam-Lausanne-New York-Oxford-Tokyo, 165-182, 1999.
  4. Mandal B. K., Biswas B. K., Dhar R. K., Roy Chowdhury T., Samanta G., Basu G. K., Chanda C. R., Saha K. C., Chakraborti D., Kabir S., Roy S., “Groundwater arsenic contamination and sufferings of people in West Bengal-India and Bangladesh: status report up to March 1998” in Metals and Genetics, Sarkar, B. (Ed), Kluwer Academic/Plenum Publishing Corp., New York, 41-65, 1999.
  5. Roy Chowdhury T., Mandal B. K., Samanta, G., Basu G. K., Chowdhury P. P., Chanda C. R., Karan N. K., Lodh D. K., Dhar R. K., Das D., Saha K. C., and Chakraborti D., “Arsenic in groundwater in six districts of West Bengal, India: the biggest calamity in the world: the status report up to August., 1995” in Arsenic: Exposure and health effects, Abernathy, C. O, Calderon, R. L and Chappell, W. R.(eds) Chapter 9, Chapman and Hall, New York, 91-111, 1997.
  6. Samanta G., and Clifford D. A., “Preservation of Arsenic Species”, AWWA Research Foundation, Denver CO, January 15, 2004.
  7. Clifford D. A., Karori S., Ghurye G. L., and Samanta G., “Field Speciation Method for Arsenic Inorganic Species”, AWWA Research Foundation, Denver, CO, August 2004.
  1. Dipankar Chakraborti, Dipankar Das, Amit Chatterjee, Gautam Samanta, “A composition useful for removal of arsenic from water and tablets/capsules made from the said composition,” India Pat. No. 1002825, 1998.
  2. Dipankar Chakraborti, Dipankar Das, Amit Chatterjee, Gautam Samanta, “A composition useful for making a water filter candle and water filter candle made thereof,” India Pat. No.1002827, 1998.
  3. Dipankar Chakraborti, Dipankar Das, Amit Chatterjee, Gautam Samanta, “An improved process for the removal of arsenic from water,” India Pat. No.1002823, 1998.
  1. Distinguished Speaker and Chairperson, International Conference on Recent Advances on Green Catalysis and Drug Discovery, Akal University, Talwandi Sabo, Punjab, 4-6 September 2024
  2. Distinguished Speaker, 4th Edition CPhI conference of PAT & QBD, Hyderabad, 21-22 March, 2024
  3. Keynote Lecture, National Symposium-cum-Workshop on Contemporary Trends, Tools, and Techniques in Pharma Quality by Design (QbD): From Conceptualization to Implementation, Panjab University, Chandigarh, 20-21 April 2023
  4. Invited speaker, 7th Advanced GPM Workshop 2022, Ahmedabad, Hyderabad, Goa, 10 -18 October 2022.
  5. Invited speaker, Attaining Quality Excellence in Drug Delivery Development & Research Emerging Trends, Tools & Techniques in Pharmaceuticals &Biopharmaceutics, Punjab University, 29 Nov-4 Dec 2021.
  6. Speaker, CPhI conference on PAT and QbD, Virtual, 21-22 April 2021
  7. Invited Speaker, “Pharma manufacturing and quality conference”, 9-11 September 2018, Riyadh, Saudi Arabia
  8. Speaker, IFPAC Annual Meeting, 3-6 March 2018, North Bethesda, MD, USA
  9. Invited speaker, “USP Workshop in Chemical Medicines,” 14-15 September 2017, Ahmedabad
  10. Invited speaker, “QbD in Pharma Development World Congress 2017”, 20-21 April 2017, Hyderabad
  11. Keynote speaker, “CPhI Process Analytical Technology Workshop,” 21-22 April 2016, Hyderabad
  12. Chairperson and Speaker, “Advance API Convention,” 20-23 July 2015, Mumbai, India
  13. Invited speaker, “QbD in Pharma Development World Congress 2015”, 16-18 April 2015, Chandigarh, India
  14. Invited talk, Workshop on Intensification & Up-scaling of Continuous Processes, 13-14 December 2013, National Chemical Laboratory, Pune
  1. QbD in Pharma Development, 24-25 February 2014, Mumbai, India
  2. Workshop on Intensification & Up-scaling of Continuous Processes, 13-14 December 2013, National Chemical Laboratory, Pune.
  3. QbD in Pharma Development, Keynote presentation, 01-02 March 2013, Chandigarh.
  4. AIChE Annual Conference, Oral presentation, Application of QbD for an existing product, 28 Nov-02 Oct 2012, Pittsburgh, USA
  5. Pharma Manufacturing-2012, Understanding the role of Quality by design in API in the manufacturing process and identifying its impact on cost, quality, and yield, 28-30 Nov 2012, Chandigarh.
  6. Pharma Manufacturing-2012, Understanding the role of Quality by design in API in the manufacturing process and identifying its impact on cost, quality, and yield, 15 – 16 May 2012, Mumbai.
  7. Pharma QbD-2012, Establishing QbD requirement for active drug substance to ensure compliance with ICH Q11 guidelines, 11 – 12 April 2012, Mumbai.
  8. Scientific Update, Developing Chemical Processes for APIs, Optimization of API: Use of Kinetic modeling and Design of Experiments, 6-7 February 2012, Mumbai.
  9. 3rd Global Innovation Conference on Democratizing Innovation: A game-changer for inclusive growth, All India Management Association, Democratization of CoP-DoE, 11-12 November 2011, New Delhi
  10. Columbia University’s Superfund Basic Research Program Seminar Series, Lamont Hall at Columbia’s Lamont-Doherty Earth Observatory, 61 Route 9W, Palisades, New York, Arsenic research and the development of automated instruments, May 16, 2005.
  1. Trained R&D scientists of Neuland Laboratories, Cipla Ltd, and Dr. Reddy’s laboratories on QbD/DoE implementation
  2. Fifty (50) published papers in peer-reviewed journals including ‘Nature’, 7 book chapters, 5 patents (3 granted patents and 2 filled), more than 30 invited lectures
  3. More than 7000 citations of research work (h-index 28 and i10-index 41)
  4. Successfully developed, optimized, and scaled up more than 100 active pharmaceutical ingredients (API), and 100 formulation products as Right-First-Time through Quality by Design (QbD) principles/ Design of Experiments (DoE).
  5. Developed more than 150 robust analytical methods using the QbD principle, Monte Carlo simulation, and other statistical approaches.
  6. Improved cost and quality for more than 30 existing high-value commercial products using DoE
  7. Successfully implemented process analytical technology (PAT) (ReactIR, Raman, FT-NIR, FBRM, PVM, Fluorescence, and UV/VIS probe, etc.) for drug products and drug substances at the commercial scale
  8. Successfully developed in-house-low cost-automated reactors (35 automated reactors at Dr. Reddy’s Lab at 1/10 cost of the commercial systems) and set up a high-throughput lab
  9. Received research grants ($500000.00) for technology development during my tenure at the University of Houston, Houston, TX, USA as a PI, and Co-PI

 HONORS AND AWARDS

  1. Received Chairman’s Excellence Award (Best Quality Driving Team-2012) from Dr. Reddy’s Laboratories for the successful implementation of QbD in API development, 2012 
  2. Received Chairman’s Excellence Award (Individual Category-2010) from Dr. Reddy’s Laboratories, Hyderabad for the development of laboratory automated reactors, 2012
  3. Invited as an adviser to the International Atomic Energy Agency (IAEA), Vienna, Austria to discuss “Exposure to toxic elements during infancy”, February 2009.
  4. Invited participant in the U.S International Visitor Program on Global Climate Change, USA, 1999.
  5. Invited speakers at IIT Dhanbad, Indian Pharmaceutical Alliance (IPA), Chandīgarh University, etc.
  6. Committee member of the course structure for M.Sc. Tech Pharmaceutical Chemistry (2018-2019), IIT Dhanbad

 Employment History

  • AGS Pharma Consulting, Founder and Director (May 2023 -)
  • Cipla Ltd., Mumbai, India, Vice President and Head-Quality by Design, and Technology Transfer (Aug 2014- April 2023)
  • Dr. Reddy’s Laboratories, Hyderabad, India, Various roles up to Associate Director (Oct 2006 -July 2014)
  • University of Houston, Houston, USA, Research Assistant Professor (May 2004 -Sept 2006)
  • University of Houston, Houston, USA, Post-Doctoral Research Associate (June 2002 – April 2004)
  • Texas Tech University, Lubbock, USA, Post-Doctoral Research Associate (April 2000 – May 2002)
  • National Institute of Health Sciences, Tokyo, Japan, Researcher (Jan 1999 – March 2000)

Skill and Training

  • Organic process optimization utilizing DoE and Chemical kinetics
  • Scale up of the organic process
  • Drug product and process optimization using DoE
  • Analytical method development following QbD
  • Process Analytical Technology
  • Multivariate data analysis
  • Statistics and Statistical Process Control (SPC)
  • Quality Risk Management

Education

  1. Ph. D.     Jadavpur University, Calcutta, India – Chemistry                            
  2. M. Sc.     University of Calcutta, Calcutta, India – Chemistry                            
  3. B. Sc.     University of Calcutta, Calcutta, India – Chemistry (Honours)       

Certification

Six Sigma Green Belt, American Society for Quality (ASQ)