Bioprocessing Specialist

pstrongJobSummary/strong/ppTheBioprocessingSpecialistpositionisresponsibleforperformingassignedmanufacturingandlaboratorysupportactivitiesaccordingtocompanypolicies,SOPs,andqualityregulations./ppThisrolewillberesponsibleforperformingupstreamanddownstreambioprocessingprocedurestosupportthecommercialmanufacturingofnativeantigens,recombinantproteins,antibodies,andblockers./ppKeyResponsibilities:/pulliCoordinatedailyproductiontaskswithsupervisorormanagerensuringalignmentwithproductionschedule./liliIndependentlycompletedailyassignedtasksfollowingappropriatemanufacturingdocuments,SOPs,andregulations./liliMonitorandrequisitionorinitiatein-houseproductionofrawmaterialsandsuppliesrequiredtomeetproductionschedules./liliAssuretheproperuse,cleaning,sanitization,maintenance,validation,calibrationandcertificationofrequiredequipmentasappropriate./liliUnderstandandapplytheconceptsofaseptictechnique./liliGenerateandrecordalldataandobservationsasrequiredandcompleteallnecessarycalculationsincompliancewithcompanypolicies./liliImmediatelynotifysupervisorormanagerofanydeviationfromwrittenproductiondocumentorSOP./liliMaintainaccuratedatasheets,records,andlogsincompliancewithSOPs,OSHArequirements,andqualitysystemrequirements./liliAuditownpaperworkdailyforcorrections,missing,and/orincompleteinformation./liliPerformroutinelaboratorymaintenanceandlabmanagementincludingorderingofmaterials,cleaningandmaintenanceoflaboratoryequipment,cleaninglabarea,environmentalmonitoring,andfillingoutproperpaperwork./liliAssist,asrequired,ininvestigationsforallproductorprocessnonconformancesincludingdeviations,OOS,CAPA,orcomplaints./liliAssistinprocedurereviewsanddocumentcorrection/improvementprocesses./liliTroubleshootandmitigateanyobservedissueswithresources,schedule,procedure,orproductqualitycollaboratingwithappropriatedepartments,supervisors,ormanagertoadheretocompanygoals./liliIndependentlycompletealltrainingasassignedandread/respondtodailycompanycorrespondencesasrequired./li/ulpstrongRequirements/strong/ppTheidealcandidatewillhaveaBachelor'sdegreeinarelevantscientificdisciplinesuchasChemistry,Biology,Biochemistry,MolecularBiology,ProteinChemistry,etc.oranAssociate'sdegreeorHighschooldiploma/GEDwith3+yearsofbioprocessingexperienceinaGMPfacility./ppPreviousmanufacturingorassemblyexperienceinaqualityregulatedenvironmentisdesirable./ppThepositionwillcollaboratewithmanufacturing,quality,materialsmanagement,technicaloperations,andotherdepartmentsasrequiredtocompleteassignedtasks./ppThepositionwillreportprogresstonecessarydepartmentsandindividuals./p