Experience

CCRM

• Biotechnology Research
• 100 - 200 Employee

• Msat Scientist

  • May 2021 - Present

  Downstream lead for Viral vector manufacture. Handled downstream equipment evaluation and selection for Viral vector clinical manufacturing.facility. Managed Tech. Transfer of cell banking projects to manufacturing. Handled material risk assessments for materials with incorporation of appropriate CAPA where needed. Managing downstream Tech. Transfer of the lentiviral platform from development to manufacturing Downstream lead for Viral vector manufacture. Handled downstream equipment evaluation and selection for Viral vector clinical manufacturing.facility. Managed Tech. Transfer of cell banking projects to manufacturing. Handled material risk assessments for materials with incorporation of appropriate CAPA where needed. Managing downstream Tech. Transfer of the lentiviral platform from development to manufacturing



Ipca Laboratories Limited

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager,

  • Jun 2020 - Jan 2021

  Purification lead, biosimilars. Handled successful Tech. Transfer of IPCA first biosimilar program at designated CMO. Responsible for development of tech transfer documents. Managing strategy of In-process testing setting of ranges for manufacturing scaledown model development. Purification lead, biosimilars. Handled successful Tech. Transfer of IPCA first biosimilar program at designated CMO. Responsible for development of tech transfer documents. Managing strategy of In-process testing setting of ranges for manufacturing scaledown model development.



Biocon Biologics

• India
• Biotechnology Research
• 700 & Above Employee

• Scientific Manager

  • Jul 2019 - Jun 2020

  Downstream lead for the Biocon-mylan partnered mab portfolio. Responsible for downstream RND deliverables are met. Activity mapping and resource management. CMC updates with internal and external stakeholders Ensuring quality compliance of the team and assessment of procedural deviations Audit preparedness and support Preparation, review and query support for global regulatory submissions Team organization, development, management and motivation. Scale-up/Tech. transfer of… Show more Downstream lead for the Biocon-mylan partnered mab portfolio. Responsible for downstream RND deliverables are met. Activity mapping and resource management. CMC updates with internal and external stakeholders Ensuring quality compliance of the team and assessment of procedural deviations Audit preparedness and support Preparation, review and query support for global regulatory submissions Team organization, development, management and motivation. Scale-up/Tech. transfer of over 6 Mab projects at multiple manufacturing sites, both internal and CMO’s Planning and closure of critical R&D studies such as scale-down model qualification, risk assessment, process characterization, viral clearance, impurity clearance, variant isolation and indicative resin reuse Show less Downstream lead for the Biocon-mylan partnered mab portfolio. Responsible for downstream RND deliverables are met. Activity mapping and resource management. CMC updates with internal and external stakeholders Ensuring quality compliance of the team and assessment of procedural deviations Audit preparedness and support Preparation, review and query support for global regulatory submissions Team organization, development, management and motivation. Scale-up/Tech. transfer of… Show more Downstream lead for the Biocon-mylan partnered mab portfolio. Responsible for downstream RND deliverables are met. Activity mapping and resource management. CMC updates with internal and external stakeholders Ensuring quality compliance of the team and assessment of procedural deviations Audit preparedness and support Preparation, review and query support for global regulatory submissions Team organization, development, management and motivation. Scale-up/Tech. transfer of over 6 Mab projects at multiple manufacturing sites, both internal and CMO’s Planning and closure of critical R&D studies such as scale-down model qualification, risk assessment, process characterization, viral clearance, impurity clearance, variant isolation and indicative resin reuse Show less



Biocon

• India
• Biotechnology Research
• 700 & Above Employee

• Associate scientific manager 2

  • Jul 2017 - Jun 2019

  Downstream Process Scale-up to 2.5kL, GAP analysis and trials at scale. Preparation/Review of Tech. transfer document and manufacturing GMP documentation BMR's Checklist,change controls.Defining manufacturing controls,inprocess testing and defining specifications. Coordination with QA,QC,regulatory,PD, Analytical Method development, Characterization, RM, Msat and production for processTech transfer. Variant isolation and product characterization. New technology identification and… Show more Downstream Process Scale-up to 2.5kL, GAP analysis and trials at scale. Preparation/Review of Tech. transfer document and manufacturing GMP documentation BMR's Checklist,change controls.Defining manufacturing controls,inprocess testing and defining specifications. Coordination with QA,QC,regulatory,PD, Analytical Method development, Characterization, RM, Msat and production for processTech transfer. Variant isolation and product characterization. New technology identification and development.Process characterization and late stage purification support

• Associate scientific manager 1

  • Jul 2015 - Jun 2017

• Principal Scientist

  • Jul 2012 - Jun 2015

• Senior Scientist

  • Sep 2011 - Jun 2012