Develops and optimizes manufacturing processes for pharmaceutical drug products. Conducts process characterization studies using statistical and risk-based tools. Scales up formulations from laboratory to pilot and commercial manufacturing scale. Develops process validation protocols, reports, and process control strategies. Applies Quality by Design (QbD) principles in process development activities. Identifies critical quality attributes (CQAs) and critical process parameters (CPPs). Uses design of experiments (DoE) to optimize processing conditions systematically. Supports technology transfer by preparing process descriptions and batch records. Investigates manufacturing failures and recommends process improvements. Collaborates with analytical development and QA teams on product development. Prepares CMC sections for ANDA/NDA regulatory submissions. Manages pilot plant and manufacturing scale equipment qualification activities. Stays updated with ICH Q8, Q9, Q10, Q11 guidelines and validation guidance.