Shubham Bhise

Experience

• 

  Mylan Laboratories Limited

  Jul 2018 - Mar 2019

  Project Trainee

  Formulation research and development (FR&D). Worked on the oral solid formulations for US, Europe, WHO, etc. markets like modified release pellets, extended-release tablets, orally disintegrating tablets, dispersible tablets. having skills and experience of handling various types of equipment like RMG, Wurster coater(GPCG), tablet coating machines, nano media mill, Spray dryer, Roller compacter etc

• 

  RiconPharma India Pvt Ltd

  Jun 2019 - Jan 2020

  Trainee scientist

  Was responsible for Formulation Research and Development small molecules (oral Solid) like Tablets, capsules(Pellets) for extended, modified, sustain release dosage forms.

• 

  Biocon Biologics

  Feb 2020 - Sept 2022

  Formulation development of lyophilized as well as liquid formulation of monoclonal antibodies.Conducting stability studies, container closure selection, moc, temperature exursion, force degradation, freeze thaw and range setting for RLD and In-house products as well as analysis of the same.Filter sizing studies for drug substance and formulation buffers. Controlled freeze thaw cycle development for drug substance.Analytical methods: Size-exclusion, Ion-exchange, Reverse phase, Isoelectric focusing and capillary electrophoresisCharacterization methods (Dynamic Light Scattering, isoelectric focusing, capillary electrophoresis, differential scanning calorimetry).Softwares used:Empower, Compass (Protein Simple), 32 Karat, SAP, Minitab, SPSS.ELN-LIMS (Electronic lab notebook) Show less Formulation development of lyophilized as well as liquid formulation of monoclonal antibodies.Conducting stability studies, container closure selection, moc, temperature exursion, force degradation, freeze thaw and range setting for RLD and In-house products as well as analysis of the same.Filter sizing studies for drug substance and formulation buffers. Controlled freeze thaw cycle development for drug substance.Analytical methods: Size-exclusion, Ion-exchange, Reverse phase, Isoelectric focusing and capillary electrophoresisCharacterization methods (Dynamic Light Scattering, isoelectric focusing, capillary electrophoresis, differential scanning calorimetry).Softwares used:Empower, Compass (Protein Simple), 32 Karat, SAP, Minitab, SPSS.ELN-LIMS (Electronic lab notebook) Show less

  • Senior Scientist

    Jul 2022 - Sept 2022

  • Scientist

    Feb 2020 - Jul 2022
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  Alvotech

  Oct 2022 - now

  Scientist

  Working in R&D DP Development department as process scientist.Actively involved in development and transfer of lyophilized DP process.Development and technology transfer at large for high concentration liquid DP.Having good knowledge on single used assemblies from different vendors and their applications in Biosimilars manufacturing.Well experienced in studies related to DP manufacturing process such as Mixing, Freeze thaw, Filtrations , Filling.