Manage in vivo team executing bioassays to assess potency and/or performance of novel drug products.* Develop and implement quality control systems and protocols per industry standards and regulations* Research and develop in vivo and in vitro bioassays* Coordinate and manage nonclinical toxicology studies* Support GMP drug product release and stability testing* Manage budget for the quality control department, including resources and staffing

Manage in vivo team executing bioassays to assess potency and/or performance of novel drug products.

Lead and oversee a team in conducting in vivo research and development studiesIdentify areas for improvement and methods of change and suggest recommendations to upper managementEnsure that the goals and objectives of team members are metPlan and coordinate activities with vivarium staff, vendors, and contract research organizations (CRO’s)Regularly apply basic theory and training in animal handling and proceduresFacilitate, plan and execute research and development experiments, analyze data and write final reportsIdentify and resolve problems and technical issues and make improvements to proceduresParticipate in method development, qualification, validation, and transfer for potential in vivo/in vitro assaysParticipate in routine in vitro/in vivo assays to support the new product development, formulation development, and product release/stability in a timely and compliant mannerProvide technical leadership and training to other lab membersProvide lab maintenance and support to ensure compliance on a regular basis. Take full responsibility to follow the test procedures, SOPs and other controlled documents in a detailed and accurate fashionResearch and develop new in vivo research models

Plan, prepare, and execute in vivo research studies Murine modelsPharmcokinetics and PharmacodynamicsPrepare and submit study protocols for reviewResearch and gather information for R&D projectsLab management/maintenanceProcure and maintain calibration servicesPlan and oversee calibration of laboratory equipmentMonitor temperature controlled equipmentAssure proper function of laboratory equipmentOrder laboratory supplies

Served as project lead Prepare and maintain projectsPerform tests on mice as outlined in project protocolsWork with Principal Investigator to plan and supervise activitiesRecord data (in the spirit of GLP)Provide assistance with project related proceduresProficient with the following mouse "Biomethods" and/or proceduresGross NecropsyBrain DissectionOral/Intraperitoneal Glucose Tolerance TestCardiac, Retro-Orbital Eye Bleed & Submandibular Blood CollectionIP, Subcutaneous, Intrarectal and Tail Vein InjectionsOvarectomy & VasectomySubcutaneous ImplantTail; up and managementWean and Change cagesObserve, record and maintain health status of project mice colonies

Obtain milk from lactating mice for analysisAdminister oxytocin injection in milking procedurePerform PCR on mouse tissue samples for genotype analysisPerform Gel Electrophoresis on PCR products.Test and refine new protocols to analyze milk from transgenic mice

Sales of computer hardware. Provide technical support for hardware manufactured by company.