Scientific Associate will draft and review scientific documentation, collaborate with QA and RA departments, and manage quality system elements. Requires a master's degree in a scientific discipline, expertise in LC-MS and chromatography, and 2+ years of quality control experience in a GMP environment.
Supports formulation and drug-product development through training, document review, and project participation. Executes experiments, performs analytical testing, and analyzes data. Prepares scientific documentation and coordinates sample handling.
Develop, optimize, and qualify RP-U(H)PLC and SEC-U(H)PLC methods for antigen content determination in drug substance samples. Conduct method performance and robustness studies, generate reports, and support technical transfer and training.