The Bioanalytical Specialist III will be leading the analysis of bioanalytical specimens obtained from pre-clinical animal studies and human trials conducted at various contract research organizations. This individual will work closely with the Principal Investigator and Lab Supervisor to ensure that these projects are completed on time and within budget. The individual will be required to follow all Standard Operating Procedures (SOPs) and Test Methods (TSMs); Good Laboratory Practices (GLP) and internal processes.
Essential Duties and Responsibilities
Lead the development and validation of ICP-MS assays in a regulated environment and analysis of non-clinical and clinical study samples.Ensure the scientific quality of data in order to meet GLP/GCP regulatory expectationLead in the analysis of bioanalytical specimens (e.g., blood, urine, tissues)Perform equipment qualifications and performance qualifications of temperature-controlled chambers.Edit and create test methods and other quality documents.Follow cGMP and cGLP standards, TSMs and SOPsCalibrate analytical instrumentation Ensure all calibration, mapping, PM/OQ activities are performedMaintain supply inventory and SDS sheets, including point of contact with Purchasing to process ordersInitiate change requestsAttend as necessary and successfully complete training on analytical instrumentation and procedures as well as other directed areas of interestReport to management any issues that may improve the lab performanceLead troubleshooting of equipment Perform and/or lead research and development experiments when necessaryCrosstrain with Quality Control to perform analytical characterizationWrite and execute bioanalytical protocols, reports, and phase plansPerforms other duties as assigned . Requirements:
A Bachelor’s degree in the sciences is required. This position prefers three or more years of experience in a laboratory environment with ICP-MS experience. Certification is not required. The employee shall be computer literate with excellent communication skills.