Amit Gaurav

Experience

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  Dhampur Sugar Mills Limited

  Jul 2009 - Dec 2010

  Process Engineer

   Laboratory set up for Biotech start up. Evaluation of equipment required for Laboratory set up and qualification. Process development and optimization for microbial batch fermentation (upto 10 L scale) for production of an enzyme, Fructosyl transferase. Handled process development for purification of Enzyme, Fructosyl transferase, Polymerisation of sugars by using Fructosyl transferase to form a pre-biotic, Fructo-oligosachharides (FOS) Production of Fructo-oligosaccharides (FOS) syrup upto 55 % content.  Development of high content Fructo-oligosaccharides (HCFOS 95%) Show less

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  Indian Institute of Technology, Bombay

  Jan 2011 - Sept 2013

  Project Associate

  Simulation and Modeling of cell movement Study of Cellular de-adhesion process during Metastasis from Biophysics and Biomechanical aspect. Development of visco-elastic mechanical model of a cell lying on Extra Cellular Matrix and simulation of it’s de-adhesion dynamics by using MATLAB. Development of visco-elastic mechanical model for array of cell connected together involving cell- substrate adhesions and cell to cell adhesions. Validation of the model developed by conducting the wet lab experiments. Show less

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  Laurus Bio

  Nov 2013 - May 2015

  Research Associate

   Handled process development for purification and optimisation of Enzymes expressed in P. pastoris. Optimization for conversion of Pro-active to active enzyme in a controlled environment. Scaled-up of microbial based enzyme purification processes from Lab to Pilot scale.

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  Syngene International Limited

  Jul 2015 - Dec 2020

  Lead a team for Downstream process development, optimization, scale up and technology transfer for Microbial based and CHO cell based monoclonal antibodies.  Designing of various filtration techniques & chromatography, its development and optimisation for purification of microbial based product (Hormones) and cell culture based product (monoclonal antibodies). Design of experiments (DOE) to select various chromatography processes and TFF. Its development and optimisation for purification of protein expressed in CHO cell.  Virus clearance studies and viral clearance validation batches.

  • Associate Scientist

    Jun 2018 - Dec 2020

  • Senior Research Associate

    Jul 2015 - May 2018
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  SUN PHARMA

  Dec 2020 - Feb 2023

  Manager

   Handled a team (Team size : 3 members), having leadership and organizational skills. Process development & optimization for Ophthalmic mAbs .  Technology transfer & Manufacturing trouble shooting. Virus clearance process validation batches. Support to regulatory team in dossier preparation & addressing queries for China submission. Preparation of Patent landscape and FTO.

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  Biocon Biologics

  Mar 2023 - now

  Associate Manager

   Techno-managerial leadership at MSAT (Downstream) Technical oversight of Scale-up, Validation activities & Manufacturing troubleshooting. Documentations: Tech transfer, MFR preparation, Gap analysis, Risk assessment, Extractable & Leachable assessment. Manufacturing data analysis, Investigation, Process improvement, CAPA and it's effectiveness evaluation. Preparation of technical documents to support product filing. Preparation of scientific justification for responding to regulatory queries for US, EU, Japan, Canada & ROW market. Show less