Seeking a suitable position in a challenging environment providing opportunities for professional growth and advancement where I can utilize experience and skills while making a significant contribution to the success of the company.
Overview
11
11
years of post-secondary education
Work History
Principal Scientist (GM)
Apitoria Research center (Formally known as Aurobindo Pharma Ltd)
1 2002 - Current
Managing a group and training the team with appropriate and updated skills to maintain a safe and healthy atmosphere and motivate them to achieve the best in time
Guide the team for literature search, planning, and monitoring of day-to-day activities
Coordination among cross-functional departments for the smooth running of projects
Effective coordination with the Strategy Purchase team for the sourcing of raw materials for all the new projects and CIP projects
Development of non-infringing, cost-effective, safe, and user-friendly processes
Developing drug substance process in a combination of 'traditional approach and enhanced approach' as per ICH Q11 guideline
Evaluation Vendor's route of synthesis of key starting materials
Based on the Vendor's route of synthesis, assessing possible impurities likely to be present in key starting materials
Preparation of possible impurities related to key starting materials and submitting to Analytical department to develop related substance (Purity) method
Generation of specifications for key starting materials and intermediates with support of purge study/trend data
Evaluating Critical Quality Attributes (CQAs) of the drug substance
Developing control strategy for process impurities as per ICH Q11 to get a consistent quality product
Generating stability data as part of process development
Coordinating with kilo lab to produce drug substances to meet FRD requirements
Developing control strategy for potential mutagenic impurities as per ICH M7 (Option 1, Option 2, Option 3, and Option 4 controls)
Developing control strategy for Nitrosamine impurities as per ICH M7
Generation of specifications for Drug Substances to ensure the quality of drug substances
Prepared about 12 Process Development Reports (PDR)
Prepared about 15 Potential Mutagenic Risk Assessment reports
Prepared about 15 Potential Nitrosamine Risk Assessment reports
Having experience in handling DEREK and SARAH software and LEADSCOPE software to predict the structural alert of query molecules
Generating documents and supporting the regulatory team to respond to the DMF query
Prepared response to USDMF/CEP query
Having analytical skills to interpret the spectral data (1H NMR, 13C NMR, GC-Mass, LC-HR-Mass, IR, X-ray) for elucidation of the chemical structures
Handful of experience in scale-up studies, process optimization, chemical reaction hazard evaluation, and GMP requirements
Coordinating with the plant to successfully complete of validation of the new product
Preparing investigation report to support plant for the closing of OOS/OOT batches.
Shankar, B. R., Senthilkumar, N., Ramesh, D., Sivakumaran, M. 'Preparation of Bupropion Hydrochloride' IN 2004CH01323.
Shankar, B. R., Somannavar, Y. S., Senthilkumar, N., Ramesh, D., Sivakumaran, M. 'An improved process for the preparation of Trandolapril intermediate' IN 1663CHE2006.
Shankar, B. R., Somannavar, Y. S., Senthilkumar, N., Ramesh, D., Sivakumaran, M. 'A new improved process for the preparation of Trandolapril Form-II' IN 2006CH01083.
Shankar, B. R., Senthilkumar, N., Kishore, G. V., Ramesh, D., Sivakumaran, M. 'Process for the preparation of angiotensin II antagonist' US 7880015, 2011.
Shankar, B. R., Sinha, B. K., Senthilkumar, N., Somannavar, Y. S., Ramesh, D., Sivakumaran, M. 'Process for preparing an optically active proton pump inhibitor' US 20100125142.
Shankar, B. R., Mallikarjuna, K. R., Senthilkumar, N., Aminul Islam, Sivakumaran, M. 'An improved process for the preparation of Meropenem sterile' IN 2108CHE2010.
Shankar, B. R., Mallikarjuna, K. R., Senthilkumar, N., Aminul Islam, Sivakumaran, M. 'Improved process for the preparation of new polymorphic form of Ertapenem sodium' IN 342CHE2011.
Shankar, B. R., Senthilkumar, N., Ramesh, D., Sivakumaran, M. 'A new improved process for preparation Clopidogrel hydrogen sulfate form-I'.
Senthilkumar, N., Kishore, K., Vittal, T., Sivakumaran, M., 'Process for the preparation of DL-Proline Co-Crystal of Dapagliflozin' US 2019/0169152.
Senthilkumar, N., Kishore, K., Sunil, G., Krishna, V., Krishnamurthy, V. R. M., 'A process for the preparation of Vigabatrin' WO 2019/180547.
Senthilkumar, N., Kishore, K., Sunil, G., Krishna, V., Krishnamurthy, V. R. M., 'A process for the preparation of Tafamidis Meglumine' IN 202041011872.
Senthilkumar, N., Kishore, K., Sunil, G., Krishna, V., Krishnamurthy, V. R. M., 'A process for the preparation of 4-Oxoisotretinoin' IN 202041035037.
Journals
Senthilkumar, N., Shankar, B. R., Brajesh, K. S., Mukkanti, K., Ramesh, D. 'New and Improved Manufacturing Process for Valsartan' Org. Process. Res. Dev. 13, 2009, 1185.
Senthilkumar, N., Somannavar, Y. S., Shankar, B. R., Brajesh, K. S., Narayan, G. K. A. S. S., Ramesh, D., Mukkanti, K. 'Synthesis of active metabolites of Carvedilol, an antihypertensive drug' Syn. Comm. 14, 2010, 268.
Senthilkumar, N., Shankar, B. R., Mukkanti, K., Narayan, G. K. A. S. S., Aminul, I. 'Synthesis and characterization of some new carbazole containing amino acid as beta-adrenoreceptor blockers' Der. Pharmacia. Lettre. 3, 2011, 252.
Pandu Ranga Rao V, Somannavar Y. S, Senthilkumar N, Shankar B. Reddy, Aminul Islam, and Hari Babu B. 'Preparation of stable new polymorphic form of Atorvastatin calcium' Der Pharmacia Lettre, 5, 2011, 48-5.3
Pandu Ranga Rao V, Somannavar Y. S, Hari Babu B. Senthilkumar N, Shankar B. Reddy, and Aminul Islam. 'Synthesis and Characterization of Atazanavir Analogues with Carbazole' NFCR, 5, 2011.
Kishore karumanchi, Senthil kumar Natarajan, Krishna Murthy V. R. Moturu, Ramadas Chavakula, Raghu Babu Korupolu & Kishore Babu Bonige. 'Resolution of racemic Vigabatrin using tartaric acid' Syn. Comm. 48, 2018, 2221.
Kishore karumanchi, Senthil kumar Natarajan, Sunil Gadde, Krishna Vanthanagiri. 'A convenient approach for vinylation reaction in the synthesis of 5-vinyl-2-pyrrolidinone, a key intermediate of Vigabatrin.' Chemical Paper, 74, 2035-2039 (2020).
Kishore karumanchi, Senthil kumar Natarajan, Sunil Gadde, Krishna Vanthanagiri and Krishnamurthy V R Moturu. 'A new synthesis of Tafamidis via zinc-MsOH mediated reductive cyclisation strategy.' J. Chem. Sci. (2021)133:48.
Job Profile
Managing a group and training the team with appropriate and updated skills to maintain a safe and healthy atmosphere and motivate them to achieve the best in time.
Guide the team for literature search, planning, and monitoring of day-to-day activities.
Coordination among cross-functional departments for the smooth running of projects.
Effective coordination with the Strategy Purchase team for the sourcing of raw materials for all the new projects and CIP projects.
Development of non-infringing, cost-effective, safe, and user-friendly processes.
Developing drug substance process in a combination of 'traditional approach and enhanced approach' as per ICH Q11 guideline.
Evaluation Vendor's route of synthesis of key starting materials. Based on the Vendor's route of synthesis, assessing possible impurities likely to be present in key starting materials.
Preparation of possible impurities related to key starting materials and submitting to Analytical department to develop related substance (Purity) method.
Generation of specifications for key starting materials and intermediates with support of purge study/trend data.
Evaluating Critical Quality Attributes (CQAs) of the drug substance.
Developing control strategy for process impurities as per ICH Q11 to get a consistent quality product.
Generating stability data as part of process development.
Coordinating with kilo lab to produce drug substances to meet FRD requirements.
Developing control strategy for potential mutagenic impurities as per ICH M7 (Option 1, Option 2, Option 3, and Option 4 controls).
Developing control strategy for Nitrosamine impurities as per ICH M7.
Generation of specifications for Drug Substances to ensure the quality of drug substances.
Prepared about 12 Process Development Reports (PDR).
Prepared about 15 Potential Mutagenic Risk Assessment reports.
Prepared about 15 Potential Nitrosamine Risk Assessment reports.
Having experience in handling DEREK and SARAH software and LEADSCOPE software to predict the structural alert of query molecules.
Generating documents and supporting the regulatory team to respond to the DMF query.
Prepared response to USDMF/CEP query.
Having analytical skills to interpret the spectral data (1H NMR, 13C NMR, GC-Mass, LC-HR-Mass, IR, X-ray) for elucidation of the chemical structures.
Handful of experience in scale-up studies, process optimization, chemical reaction hazard evaluation, and GMP requirements.
Coordinating with the plant to successfully complete of validation of the new product.
Preparing investigation report to support plant for the closing of OOS/OOT batches.
Personal Information
Date of Birth: 08/09/77
Marital Status: Married
References
Dr. V. K. Handa, Ex-President, Aurobindo Pharma Ltd.
Dr. K. Ramana, Ex-Vice President, Aurobindo Pharma Ltd.
Timeline
Ph.D. - Chemistry
J.N.T. University
01.2006 - 05.2011
M.Sc. - Chemistry
Bharathidasan University
01.1999 - 05.2001
B.Sc. - Chemistry
Madras University
01.1996 - 05.1999
Principal Scientist (GM)
Apitoria Research center (Formally known as Aurobindo Pharma Ltd)
1 2002 - Current
Similar Profiles
SRI ADI LAKSHMI KAMESWARI PRABHALASRI ADI LAKSHMI KAMESWARI PRABHALA
Senior Research Associate at Aurobindo Pharma RESEARCH CENTERSenior Research Associate at Aurobindo Pharma RESEARCH CENTER