Supervisor, QC Microbiology (Swing Shift)
Location Novato, California Workstyle Onsite Only ApplyBioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Role Summary:
- SupervisetheQCMteamwhileembodyingtheprinciplesoftheBIOMARINLeadership model.
- Interviewandhirepotentialcandidatestofulfillbusinessneeds.
- MotivateandretaintalentedindividualswithintheQCMDepartment
- Manage and develop the performance of direct reports by setting clear performance goals,providingtimelyperformancefeedback,recognizingandrewardinghighachievers, and holding reports accountable for underperformance.
- Timelyaddressdisciplineandperformanceissues
- EnsureexecutionofQCMlaboratoryactivitiesinstrictaccordancewithStandard Operation Procedures, GMP and Regulatory requirements
- Schedule and/or deliver training to QCM personnel in accordance with Department TrainingPlantoensurestaffcanperformassignedtaskscorrectly,safelyandcompliantly.
- ProductionandRoutine Support
- Assigntasks,createandupdatelaboratoryschedule.
- SuperviseoperationsintheQCMLabduringtheapplicableshift.
- Representthefunctionalareainmeetingsandcomplianceactivities.
- Analyzeenvironmental and utilities monitoringsample collectionandtestingoffacilities,equipment,and utilities.
- AnalyzeIn-Processdataandgeneratetrending/productreviewreports
- Reviewandauditdocumentationtoensureaccuracy,specificationsandGMP compliance
- Coordinateandoverseeslaboratorytestingexecutiontoproduceresultsintimely manner without compromising quality.
- ReviewSOPs,coordinatemethoddevelopmentandensuresconcurrencywithcGMP regulations and requirements.
- Maintainandcontrollaboratoryinventories.
- Maintainpositiverelationshipandnetworkeffectivelyacrosssitesandorganizations.
- Validatemethodsandlaboratoryequipmentandwrite procedures.
- Providelaboratorysupportforinspectionreadiness.
- WorkwithProjectTeamstodrivetimelinesandeffortstothecommongoal.
- Ensurescompliancewith21CFR,USP,EP,andICHregulatoryguidelines.
- Utilizeprocess,technicalknowledgeandinvestigationskilltoidentifyandrectify departmental issues.
- ContributetotheimprovementofallQCM systems.
- Assistinthedevelopmentofproceduresandtroubleshoot assays.
- EnsurePersonnelProtectiveEquipmentisusedinthelaboratoryarea
- Ensureproperhandlinganddisposalofchemicalandreagents
- Encouragesafetybehaviorwithinthelaboratoryarea
- Timelyaddresssafetyincidents
- Responsibleforthedocumentationandinvestigationoflaboratorydeviations,errors,and out of specifications/out of tolerance results
- ParticipateintheinvestigationofAlert/Action,excursionsandatypicalresults
- Exceptional People Leadership including motivates, inspires, builds, and retains highly effectivelaboratoryteamswhilemanagingforhighperformanceanddevelopingothers.
- Versatilelearnerandcourageousdecisionmaker.
- Effectivelyoperateinanevolvingcomplexanddynamicenvironment.
- Providescleardirectionandinstructiontodirect reports.
- Continuouslylookinginternallyandexternallyforbestpracticesandareasfor improvement.
- Understandspatientandcustomerneedsandbuildsrelationshipsasrequiredtomeet departmental goals.
- Continuouslyimprovesoperationsbysettinghighstandardsfortheteamsotheymay perform to a level of excellence.
- Detailedknowledgeofqualitymanagementsystems,currentGoodManufacturing Practices,
- ExpertisewithQCprinciplesandcompliancerequirementsisrequired.
- Excellentdocumentation,writtenandverbalcommunicationskillsareessential
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
In the U.S., the salary range for this position is $ 88,000 to $ 132,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.