LTD/TOX-高级分析化学专家（制剂方向）

1. Responsible for analytical method development execution. Direct and train the analyst in the development of analytical methods and ensure adequate validation of this method in accordance with SOP, regulatory guidance and analytical documentations. 2. Generates analytical method documentations, method validation protocols, validation reports, and their amendments for analytical studies and supervises the analytical aspects of toxicology studies as described in the study protocol. 3. Ensures the review of analytical data, investigates anomalies and unforeseen events that could potentially affect the integrity of analytical results. Responsible for the interpretation of data and reports generated by the department and produce impact statements. 4. Communicates regularly with the analysts, Study Directors and Sponsors to keep everyone informed of the progress and results from the analytical aspects of toxicology studies. 5. In conjunction with management, will participate in training staff in proper laboratory techniques and procedures.