Senior Scientist leading analytical method validation for gene therapy products, ensuring regulatory
岗位职责
The Senior Scientist in QC Analytical Method Validation is responsible for leading the validation and transfer of analytical methods used in quality control for gene therapy products.
This role involves designing and executing method validation protocols, including specificity, linearity, accuracy, precision, and robustness studies.
The scientist will oversee the qualification of analytical instruments and ensure compliance with regulatory guidelines (e.g., ICH, USP, FDA).