The Lab Manager will be responsible for: General management of R&D laboratories and biosafety of the laboratory environment General management of R&D laboratories which includes 1) managing R&D laboratories, including Biosafety Level –II laboratory; 2) responsible for logistics and coordination of equipment qualification, maintenance, repair, verification and validation; and 3) inventory management and ordering.What you will doGeneral management of R&D laboratories and BSL-II laboratoryResponsible for managing and coordination of logistics for instrument/equipment qualification (IQ/OQ,PQ), maintenance, and repair as required by product development need and in compliance with our quality system requirementDirectly interact with selected vendors and contract service providers and to ensure that Corporate insurance requirements are adhered to for vendors/contractors conducting business at the siteWorking with R&D managers and staff members to ensure inventory of general lab and reagent supplies meet R&D need in a cost-effective manner; and to coordinate general laboratory maintenance activitiesWorking with QA to properly document activities related to laboratory management such as equipment calibration/verification/qualification/maintenanceWrites and/or implements changes to controlled documents related to general laboratory practicesResponding to equipment alarms and emergency situationsWorking closely with Austin facility manager to ensure that the functionality of facility system meets the need of R&D laboratories (e.g. HVAC, UPS, generator, power supply for equipment, etc.)Work closely with other departments and other Luminex sites to ensure that compliance is maintained across the organizationComplete routine property inspections to determine extent of needed services requiredMaintain safety procedures and manuals to ensure compliance with all applicable safety regulationsMaintain biosafety procedures and manuals to ensure compliance with applicable biosafety regulationsAssist in process validations and process improvement to support operational systems as per quality systemProvide supervision to staff involved in general laboratory support activities.All other activities related to lab management coordination and special projects as neededOther duties as assigned.Education QualificationsBachelor's Degree in Biology, Biochemistry preferredExperience QualificationsExperience in managing laboratory and instruments/equipment management requiredExperience with biosafety requirement preferredExperience within the in vitro medical device industry or FDA regulated environment preferredexperience in lab equipment and processes improvement preferredTraining and SkillsKnowledge and understanding of quality system is required, experience with quality system is highly desiredExcellent verbal and written communication skillsExcellent organizational skillsExcellent time management and planning skillsExpert knowledge of process and equipment validation methodologies.Demonstrated proficiency in application of 21 CFR Parts 11, 210, 211, 820, and 1271.Highly motivated; results driven and goal oriented; consistently takes initiativeStrong verbal and written communication skills, including presentation and facilitation skills.Extensive experience negotiating with and influencing internal and external team members.Excellent judgment, willingness to make decisions and ability to push back on others (i.e., say no) when appropriate.Willingness to work flexible hours.Independent and self-directed individual.Travel Requirements10% Travel may be required