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Summary

Professional with two experiences in biotechnology field. Excellent interpersonal skills and successfully working in Bio-pharmaceutical Company. Main areas of expertise include: process technology transfer, process development and validation, bio-processing, GMP manufacturing documentation and process operation in downstream process. I have advanced knowledge of bio-pharmaceutical research aspects in relation to drugs development, cGMP, Quality Aspects, CMC and Regulatory Requirements for India (CDSCO), US (US-FDA), EUROPE (EMA), JAPAN (PMDA).  ICH Guidelines, Qualification of equipment, Risk Assessment, Quality by design, Effective problem solving and decision making ability

Work experience

Dec 2014Present

Manufacturing Executive                                                                                                           

Biocon Biopharmaceuticals, Bangalore                                                                                  
  1. Human Insulin and Insulin Glargine (Produced by using Pichia pastoris.) downstream process Centrifugation(Disk stack Centrifuge 20 Kg capacity), Cation exchange chromatography(282.74 lit. capacity), Transpeptidation , Precipitation
  2. Troubleshooting and deviation investigation
  3. Preparation of Standards operating procedure (SOP)
  4. Expert in visual management for manage own work in a safe, clean, organized environment that fosters open communication, pride, and continuous improvement (6 S )
  5. Versed knowledge of Process development and manufacturing science and technology (MSAT).
Jun 2013May 2014

Process Engineer

Seema Biotech. Talsande, Kolhapur

I successfully handled for two process plants with a team of 15 people. I developed many of skills all those that have come under my job profile like; complete the requirements and results by communicating job expectations, planning and monitoring. Maintaining work flow, observe control points of equipment record results of the process flow sheet and maintain quality service by enforcing SOPs.

Education

Jun 2014Nov 2014

Biocon-KGI Certificate in Biosciences                                                                            

Biocon Academy, Bangalore (Keck Graduate Institute, California)                                                                                     

This course gives us advanced training of bio-pharmaceutical aspects in relation to drugs development, clinical studies, GDP, cGMP and commercialization. I trained for the development and implementation of new technologies for cost effective productivity enhancement and facility development in emerging market for the Biologics. This Technology mainly contains alternative tangential flow per fusion system, development of mega mammalian cell bank, single use disposable reactor, plug and play facilities, advanced wireless sensor technology etc.

Jun 2009Jun 2013

Bachelor of Engineering in Biotechnology

Shivaji University, Kolhapur, MH