Role Summary Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA submission batches, in a regulated development and manufacturing environment. Essential Duties and Responsibilities • Review Literature and gather patent and published articles on the selected projects. • Analyze and interpret results in written and oral format in consultation with Product Development Management. • Determine best possible strategy for formulating assigned projects and meet regulatory criteria. • Perform pre-formulation studies and physical-chemical characterization of materials and dosage forms. • Perform formulation experiments to develop ANDA or NDA submission batches. • Responsible for CMC documentation, project documentation and for preparing necessary technical reports. • Perform all the processing steps such as weighing, blending, milling, compression etc. • Directs the work and schedules of technicians and provides technical assistance to associates and other formulation scientists. • Maintain accurate lab notebooks and complete all related development reports, in compliance with departmental needs and SOPs. • Technical responsibility for interpreting, organizing, executing and coordinating assignments and assigned development projects. • Maintains liaison with individuals and units within or outside of the organization as directed by Product Development Management. • Plans, organizes and supervises the assigned work staff of associates and technicians. • Responsible for project management of assigned product development projects. • Responsible for the production of clinical supplies • Ensure equipment and materials are available in a timely fashion for submission batches and to coordinate with the manufacturing department as needed. • Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and safety practices