Develops synthetic routes for active pharmaceutical ingredients (APIs). Conducts lab-scale synthesis and optimization of chemical processes. Performs route scouting, reagent optimization, and impurity profiling studies. Develops analytical methods for characterization of APIs and intermediates. Prepares chemical development reports and lab notebooks for documentation. Scales up chemical processes from laboratory to kilogram-scale production. Collaborates with QC for analytical method development and validation. Supports technology transfer to API manufacturing plants. Prepares drug substance sections for ANDA, NDA, and EDMF submissions. Identifies and characterizes process-related impurities and manages ICH limits. Evaluates green chemistry approaches for sustainable API synthesis. Ensures laboratory safety compliance and EHS standards in chemical research. Stays current with ICH Q11, Q6A guidelines, and synthetic chemistry literature.