Bioanalytical Lead Scientist - Level I

Job description

Lead Scientist - I BioA in Indianapolis, IN Work Schedule: Monday-Friday (Day Shift): Job Responsibilities: - Leads and directs scientific work to support external methods and projects. - Serves as an SD, RS, CS, LS, or PI for non-regulated, GLP-regulated, and GCP-regulated studies as applicable. - Ensure client programs meet Labcorp, client, and regulatory requirements in order to meet defined milestones along the drug development pathway. - Develops and reviews protocols and sample analysis plans. - Reviews data with the Method Development Team to ensure methods are ready for validation. - Approves validation methods and reviews sample analysis methods. - Independently reviews and approves raw data. - Ensures that any circumstances that may affect the quality and integrity of the study are identified and documented as they occur and appropriate corrective action is taken. - Effectively evaluates data and tables to ensure regulatory guidelines and expectations are met. - Reviews and approves reports for scientific accuracy and completeness. - Ensures on-time delivery of high-quality data and reports. - Provides technical support as needed. - Leads efforts to troubleshoot and solve...