Supervisor, QC Microbiology
Location Novato, California Workstyle Onsite Only ApplyWHO WE ARE
BioMarin’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: Swing shift, 4 10hr shifts (Wednesday-Saturday) 11am-10pm onsite in Novato, CA
BioMarin’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: Swing shift, 4 10hr shifts (Wednesday-Saturday) 11am-10pm onsite in Novato, CA
The Quality Control Microbiology (QCM) Supervisor is responsible for supervising a GMP laboratories supporting microbial test and release of drug substance intermediates from biopharmaceutical manufacturing from cell culture up through final formulation and the environmental monitoring and utilities monitoring of GMP facilities. Additional responsibilities include investigative testing, sterility testing, microbial identification, aseptic processing, and contamination control. This position is responsible for supervising the work of several analysts, performing and reviewing a wide variety of tests/results for biological, biochemical and chemical test reactions, environmental monitoring sampling, microbial identifications, and reagent preparation. All responsibilities must involve a working knowledge that includes but is not limited to the following concepts: facility and utility EM sampling, water testing, Endotoxin detection, Bioburden quantification, Total Organic Carbon, microbial identification and challenge studies, aseptic techniques, and method validation. In addition to technical expertise, this role is intended to offer guidance for group and individual trajectories, and actively set a standard for teamwork.
CHARACTERISTICS
This motivated and organized individual with strong people skills will provide supervision and technical expertise to the QCM labs while maintaining open communication channels with multipledepartmentstomeettheneedsoftheorganization.Theincumbentwillprovidedayto day direction to staff and support laboratory activities.
RESPONSIBILITIES
PersonnelManagement:
- 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
Training/Compliance
- 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.
Continuous improvement
- Utilizeprocess,technicalknowledgeandinvestigationskilltoidentifyandrectify departmental issues.
- ContributetotheimprovementofallQCM systems.
- Assistinthedevelopmentofproceduresandtroubleshoot assays.
Safety
- EnsurePersonnelProtectiveEquipmentisusedinthelaboratoryarea
- Ensureproperhandlinganddisposalofchemicalandreagents
- Encouragesafetybehaviorwithinthelaboratoryarea
- Timelyaddresssafetyincidents
DeviationManagement
- Responsibleforthedocumentationandinvestigationoflaboratorydeviations,errors,and out of specifications/out of tolerance results
- ParticipateintheinvestigationofAlert/Action,excursionsandatypicalresults
BASICQUALIFICATIONS
B.S.degreeinabiologicalorbiochemicalscienceandatleast5yearsofexperienceina pharmaceutical laboratory (at least 2 years in QC) that includes some supervisory experience.M.S. degree with at least 2 years of GMP laboratory experience.
LEADERSHIPQUALIFICATIONS
- 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.
PREFERREDQUALIFICATIONS
Candidate must be a motivated employee capable of working in a fast-paced environment to producequalityandtimelyresults.Experiencedmanagingdirectreportsandprocesses.Strong time management and organizational skills.Strong people skills.Training experience.
Experiencedinfacilitatingmeetings.Abilitytoeffectivelymaintainateam-workenvironment. ExperienceauthoringandreviewingSOPs,OJTs,testrecordsandothercontrolleddocuments.
EXPERIENCE
- 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.