Objective :
A synthetic organic chemist with the expertise in the development of innovative processes & novel routes of Active Pharmaceutical Ingredients (API) and Intermediates through non-infringing, patentable and cost-effective process, scale-up for commercial production and assisting in documentation for filing in various regulated markets (especially Europe & US).
Summary :
I have 16 years experience in development, scale-up & technology-transfer for commercial production of API in various pharmaceutical industries as per GMP. I have handled more than 30 APIs mainly in oncology segments. I have reduced cost of 8 API’s by 30-40% on scale-up. I have increased the Yield of 6-7API’s by 20-30%. I have a sound knowledge of trouble shooting during scale-up and technology transfer.
Expertise :
An organic chemist by training with an expertise in the
Development of non-infringing & patentable process for generic Active Pharmaceutical Ingredients (API)/ Intermediates
Scale up of the developed pilot plant
Transfer of technology for the commercial manufacture of API/Intermediates for advanced/regulated markets especially Europe & USA and Domestic market.
Having good knowledge of reactors, centrifuges and production equipments.
Job profile :
Presently I am working as a Senior Research Scientist at the Process development Lab (pilot plant) with M/s Fresenius kabi oncology Limited, Sahibabad, Ghaziabad, U.P.
My job profile involves following activities :
Designing synthetic patent non-infringing & patentable pathways for target structure after searching literature
Exploring above pathways in the laboratory, pilot plant & plant level for various regulated markets
Selection of the best approach/scheme producing API of acceptable specifications at the minimum cost, measured at the manufacturing site
Development, optimization and validation of selected scheme at the laboratory level.
Scale-up of Active Pharmaceuticals Ingredients from Laboratory level to pilot plant level and trouble shooting at the pilot plant
Validation of the selected approach at the pilot plant
Transfer of the technology to the manufacturing site for commercial production
Assistance and trouble shooting during product life cycle and ensure proper documentation in filing DMF
Setting specifications (in house) for raw materials, intermediates, solvents, drug substance in collaboration with Scientist and Analytical Development
Acquainted with interpretation of results of various analytical instruments (HPLC, GC, IR, NMR, Mass, GC-Mass etc).
Experience :
S.No.
Designation Tenure Organisation Name
1. Senior Research Scientist August 2008 to till present Fresenius kabi oncology Limited
2. Senior Research Scientist August 2008 to till present Dabur Pharma Limited, Ghaziabad
3. Executive officer Oct.1994 to July 2008 Dabur Research Foundation,Ghaziabad
4. Chemist April1992 to Oct : 1994 Montari Industries Ltd., Tonsa , Ropar
5. Trainee Februaryl1992 to April 1994 Shivalik Rasayan LTD,Dehradun
Achievements & Credentials :
1. Reduced the cost of 7-8 APIs by just slight modifications in the process.
2. Improved the yield and quality of 5APIs on the pilot-plant.
Education :
M. Sc. (Chemistry)
B.Sc(Chemistry,Maths)
Diploma : Regulatory Affairs
Diploma : Pursuing in QA & QC
Certificate : IPR from WIPO On line course Introduction to patent cooperation treaty (From WIPO)
Graduate (online) Steroid University
Experience : 16Years
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