职位描述: JobPurposeProvidestotheSitethespecialistknowledge,asSubjectMatterExpert,ofspecificpharmaceuticalprocessesorprocesstechnologies(e.g.TechnicalStewardforGalenics,forfilmcoating,biologics–upstreamordownstream,etc).Overseesprocessesandstandardstomaintainandimproveexistingandtoimplementnewinnovativemanufacturingtechnologies.MajorAccountabilitiesKnowledgemanagement:?Ownstheknowledgeofspecificpharmaceuticalmanufacturingprocesstechnologies,locally,includinganypilotscale,scaleupordown,andDesignofExperiments(DoE).?ProvidesandassuresthefundamentalknowledgeinthespecificareaofexpertisethroughtheprovisionofregulartrainingandeducationprogramsforProcessExpertsandOperators.?AssuresthatthenecessarybenchmarkisdoneinternallyinNovartis,andexternallyinthescientificandacademicenvironment,inordertostimulateandtoextendtheknowledge,increasingtheknow-howoftheassociatesandexpandingittotherestoftheorganization. SubjectMatterExpertSMEforTechnologyplatform:?DeepSubjectMatterExpertiseforspecificTechnologyPlatform(e.g.filmcoatingetc)orpharmaceuticalprocesses(e.g.galenical,chemical,biologics–upstreamordownstream,etc.)followingprocessproduct/processtransferorhandoverfromlaunchtocommercialproduction.?Designsandcontrolsoptimizationprojectsrelevanttohis/herspecificexpertise.?ProvidesSMEexpertisetoperformprocesscharacterizionoftherelatedpharmaceuticalprocessestoincreaserobustnessandsustainability.?SupportsProcessExpertsandProductStewardsintroubleshootingbyprovidingsecondlevelofspecialistexpertiseasSubjectMatterExpertsandbyharmonisingandoptimisingrelatedtechnicalprocessesacrosstheunits. SinglePointOfContact(SPoC)forthetechnology?ActsastheSPoCfortheinterfacewithglobalMS&Tnetworkandwithtechnicaldevelopmentorganization,forthecorrespondingglobalactivities,todefineandimplementnewtechnicalstandardsforexistingandnewtechnologiesandequipment(e.g.,manufacturingequipment,ProcessAnalyticalTechnologiesPAT).?Collaboratewithtechnicaldevelopment,othersitesandglobalMS&Tnetworktofacilitatetransferoftechnicalknowledge.Responsibletoperformtechnicalfeasibilitytrialsrelatedtoprocessimprovementandimplementationofnewmanufacturingtechnologies.Selectionofprocessequipment?Participateinthedefinitionandselectionofpharmaceuticalequipment,throughprovidinginputtoUserRequirements(URS)Auditsupport?Maintaintheirworkininspectionreadinesslevelandprovidethenecessarysupportinanyinternalor IdealBackgroundEducation(minimum/desirable):?BSc.inPharmacy,PharmaceuticalTechnology,Chemistryorequivalentscientificdegree.?DesirableMSc.orequivalentexperience.Languages?FluentinEnglishandproficientinsitelocallanguage.RelevantExperiences?Minimum8years’experienceinGMPmanufacturingrelevanttothespecialistareaofexpertise.?Provenprocessunderstanding(Pharma,GMP,Regulatoryaspects).
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