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7 days ago


India Biocon Full time

Department Details Role Summary Role Summary We are looking for enthusiastic and motivated individuals to join our Analytical Sciences team Key Responsibilities Experience Skills Required Relevant experience in biopharmaceutical industry in analytical method development qualification transfer in-process stability sample testing CQA assessment biosimilarity analysis of monoclonal antibodies insulin analogues pegylated proteins antibody-drug conjugates therapeutic peptides Experience in pharmaceutical industry generics complex generics peptides in chromatographic methods with strong foundation in analytical chemistry In-depth knowledge of various analytical technologies including chromatography SEC IEC RP HIC HILIC capillary electrophoresis CGE iCIEF CZE and spectroscopy UV280 SoloVPE Independently design execute and record experiments in electronic lab notebook Labware-LIMS Interpret and analyse data using relevant instrument software s Empower Chromeleon 32 Karat Compass for iCE 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 Empower Method Validation Manager 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 Qualifications Required Education Qualification Msc Required Experience 1 - 4 years



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