1+ months

Senior Manager Engineering - Downstream

Genentech
Oceanside, CA 92054

Summary

ResponsibleformanagingandprioritizingscientificandtechnicalsupporttoDownstreamManufacturing, tech Transfer Team,towardimprovingandoptimizingoperations.Supportisaccomplishedthroughdemonstratedproficiencyin experimentaldesign,complextroubleshooting,andadvanceddataanalysistechniques;identificationof processbottlenecksandvulnerabilities;planningforcampaignsandleadingnewproductintroductions; andrecommendationandimplementationofnewtechnologies.Leadscomplextroubleshootingof process,developsnewequipmentrequirementsandoperatingparameters,andprovidesandleads process validationsupport.Investigatesoperationalandprocessdiscrepancies,implementscorrectiveaction, anddevelopsandvalidatesmanufacturingimprovements.

Job Responsibilities

  • Managestaffthroughdirectsupervisionintermsofprojectcoordination,resourceallocation, budgetcontrol,andappliedmethods.
  • Motivateandsupportthecareerdevelopmentandtechnicalexpertiseofreports,and communicatecompanypolicies.
  • Anticipateresourcerequirements,delegateappropriately,andassurereportsareproductiveand workisfocused.
  • Responsibleforcompletionoftechnicalassessments,andinvestigation,development,validation, andexternalpublicationswhereappropriate.
  • Create,review,andapprovemanufacturingdocuments.
  • Contributetoregulatoryfilings.
  • Workcloselywithinterdepartmentalstaffandcustomerstomeetdepartmentandcompanygoals.
  • Mayberesponsibleforresourcingandoperationsofthecellculture,purification,oranalytical operationslaboratories.
  • Contributestoadvancesintechnologicalcapabilities.
  • Monitorsmallscaleandlarge-scalecellcultureorpurificationprocessestoidentifyandresolve complexequipmentandprocessingissues.
  • Mayberesponsibleforreview/approvaltechnicalassessments,anddraftsinvestigation, development,validation,andexternalpublicationswhereappropriate.
  • Designandexecutestudiesandcomparabilityprotocolstosupportmanufacturingoperations.
  • Leadsadvancementintechnologicalandorganizationalcapabilities.
  • AllemployeeswithjobsthatrequireaccesstotheWarehousemustbeabletopasstheTransportationSecurityAdministration(TSA)SecurityThreatAssessment(STA).
  • PromotesasafetyculturethatsupportcontinuousimprovementintheEHSmanagementsystem throughactivecommunicationandfunctionalareaparticipationinsitesafetyteamsensuringthe safeandefficientoperationofassignedfunctionalareasandactivities.Fostersapositivesafety cultureinwhichnoonegetshurt.

Job Requirements

EducationandExperience

  • Bachelors,Masters,orPh.D.degreeinEngineeringorLifeSciences.
  • 7+yearsexperience,includingsupervisoryexperience;guidelineonly.

Knowledge, Skills and Abilities

  • Abilitytoorganizeandproblemsolve.
  • ExtensivepracticalandtheoreticalexpertiseinbiopharmaceuticalDownstreammanufacturingprocessesand processvalidation.Emergingauthorityintheirfield.
  • Contactwithcollaborators,regulatoryagencies,andvendorsinsideandoutsidethecompany includingcoordinationacrossorganizationallines.Developsa networkfortechnicalissueswithin theindustry.
  • Musthaveexcellentmanagement,communication,interpersonal,organizationalandproject managementskills.Demonstratedabilitytoworkaspartofamulti-disciplinaryteam.
  • Familiaritywithcomputer-basedsystems.

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Posted: 2021-06-16 Expires: 2021-08-15

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Senior Manager Engineering - Downstream

Genentech
Oceanside, CA 92054

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