Primary Job Purpose:
Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA submission batches, in a regulated development and manufacturing environment.
Position Summary
· 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.
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.
· 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.
