This position's key function is to support Product Development by conducting research directed toward development of new formulations and/or formulation platforms for a significant PD project or a number of small projects with many complex features under minimal supervision using established and novel technology. This role is responsible for the formulation development and evaluation of complex pharmaceutical products such as controlled release solid oral dosage forms, liquids, or parenterals.
Performs literature and patent searches to provide background basis for development plans.
Executes, and assists in the evaluation of formulation development, scale-up and process transfer activities. May lead initiatives within the Product Development group.
Writes, reviews, and approves cGMP documentation including batch records, protocols, SOPS, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc.
Ensures training for self and other PD personnel, as requested. May identify and develop specific training content to support ongoing development efforts.
Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.
Maintains and expands knowledge of current and new formulation development technologies and manufacturing processes (ours and competitive).
Advances process technologies and supports the patent (intellectual property) development.
Provides mentoring to less senior Scientists.
Assist department management on various project activities.