Associate Scientific Manager I

Department DetailsRole Summary Relevant experience in biopharmaceutical industry in proof-of-concept studies bioassay method development qualification transfer stability sample testing CQA assessment biosimilarity analysis of monoclonal antibodies insulin analogues pegylated proteins antibody-drug conjugates therapeutic peptides Knowledge on ICH USP and WHO guidelines systems biology and its relevance to drug development in biopharmaceutical industry Proficiency with aseptic technique of handling tissue culture model Thorough understanding of cell culture and hands-on experience with in vitro bioassay techniques and their applications in cellular signalling receptor binding cytokine secretion cell proliferation cytotoxicity antibody effector function and immune assays Experience with novel technologies including but not limited to HTRF AlphaLISA Luminescence ELISA Flow Cytometry SPR BLI Proficiency in handling instruments like Plate Reader Flow Cytometer Biacore Octet and familiarization with 96 384 well formats of assay Independently design execute and record experiments in electronic lab note-book Labware-LIMS following ALCOA principles Interpret and analyse data using relevant instrument software and disseminate results through reports data presentations in team meetings Able to troubleshoot critical issues and determine possible solutions Maintain instruments in coordination with operations team and support installation of new instrument Keep track of ordering and maintaining inventory of consumables reagents and support in lab maintenance Familiarity with statistical tools GraphPad Prism JMP Document Management System DMS Digital Quality Management Software Trackwise is desired Author or review documents including method development reports protocols qualification transfer study and reports qualification transfer study Prepare operating procedures IOP EOP SOP and author change controls deviation and CAPA Work primarily as an individual contributor and train and cross-train colleagues towards experimental design execution and troubleshooting technical review of raw data Key Responsibilities Relevant experience in biopharmaceutical industry in proof-of-concept studies bioassay method development qualification transfer stability sample testing CQA assessment biosimilarity analysis of monoclonal antibodies insulin analogues pegylated proteins antibody-drug conjugates therapeutic peptides Knowledge on ICH USP and WHO guidelines systems biology and its relevance to drug development in biopharmaceutical industry Proficiency with aseptic technique of handling tissue culture model Thorough understanding of cell culture and hands-on experience with in vitro bioassay techniques and their applications in cellular signalling receptor binding cytokine secretion cell proliferation cytotoxicity antibody effector function and immune assays Experience with novel technologies including but not limited to HTRF AlphaLISA Luminescence ELISA Flow Cytometry SPR BLI Proficiency in handling instruments like Plate Reader Flow Cytometer Biacore Octet and familiarization with 96 384 well formats of assay Independently design execute and record experiments in electronic lab note-book Labware-LIMS following ALCOA principles Interpret and analyse data using relevant instrument software and disseminate results through reports data presentations in team meetings Able to troubleshoot critical issues and determine possible solutions Maintain instruments in coordination with operations team and support installation of new instrument Keep track of ordering and maintaining inventory of consumables reagents and support in lab maintenance Familiarity with statistical tools GraphPad Prism JMP Document Management System DMS Digital Quality Management Software Trackwise is desired Author or review documents including method development reports protocols qualification transfer study and reports qualification transfer study Prepare operating procedures IOP EOP SOP and author change controls deviation and CAPA Work primarily as an individual contributor and train and cross-train colleagues towards experimental design execution and troubleshooting technical review of raw data Educational QualificationsRequired Education Qualification Phd Required Experience 3 - 5 years