External Manufacturing Manager

vor 2 Monaten


Wien, Wien, Österreich Valneva Vollzeit

pWeareaspecialtyvaccinecompanythatdevelops,manufactures,andcommercializesprophylacticvaccinesforinfectiousdiseasesaddressingunmetmedicalneeds./ppOurteamisresponsibleforthecommercialmanufacturingofvaccines,includingtechnicalreviewsofprocesschangerequestsanddeviationreports./ppbKeyResponsibilities/b/pulliLeaddailytechnicalactivitiesforcommercialmanufacturing,includingtechnicalreviewsofEPprocesschangerequestsanddeviationreports./liliManageprojectsrelatedtocommercialvaccineproduction,includingprocessimprovements,capacityincreases,andnewproductintroductions./liliConducttechnicalevaluationssuchasDeviationsandCAPAs./liliDevelopandimplementproductionandproductstrategy,translatingExM/productstrategyintoexecutabletechnicalplans./liliOverseetechnicalriskmanagementandproductlifecycle,includingtechtransferandproductlaunches,ensuringdevelopmentandadherencetotechnicalriskmanagementplans./liliIdentifyandresolvetechnicalissues,troubleshoot,andleadproblem-solvingefforts./liliManageChangeControl,providingtechnicalimpactassessmentsforchangecontrolsandproductcomplaints./liliReviewandapprovedocumentslikeMBRs,riskassessments,qualificationprotocols,andCMCdocuments./li/ulpbRequirements/b/pulliDemonstratedabilityandexpertiseinsupportingday-to-dayactivitiesrelatedtofunctionaltechnicaloperationsinacGMPmanufacturingsetting./liliSeveralyearsofexperienceinlarge-scalecommercialpharmaceuticalmanufacturing./liliProfoundknowledgeinformulationandprocessdevelopmentofsterileinjectableproductswithhands-onexperienceinaplantsetting./liliExperienceworkingwithexternalsuppliersorwithinacross-functional,matrixorganizationisdesired./liliLeadershipskills:capableofleadingandguidingothers,especiallyincross-functionalteams./liliHands-on,results-orientedanddynamicteamplayerwithextensiveprojectmanagementskills./liliUnderstandingofcGMP,post-approvalchanges,ICHguidelinesandregulatoryvalidation./liliFluentinEnglish,Germanisanadd-on,willingnesstotravel./li/ulpbBenefits/b/pulliOpen,appreciativecompanyculturewithinnovativespiritandattractiveassignments./liliInternationalsurroundingwithflathierarchies./liliGoodteamspiritinastrongandhighlymotivatedteam./liliWiderangeofbenefitslikeflexitime,compensationdays,performance-relatedbonus,lunchvouchers,childcarecenter('Kindergarten'),companyevents,myClubs,fullaccesstoLinkedInLearning,.../li/ul



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