Supports the Group Leader/Manager in research and development of immediate and controlled release solid dosage forms with emphasis on robust compositions and optimization of process parameters.

Responsibilities:

• Support Product Development team, to facilitate the development and commercialization of immediate release and modified release solid oral dosage forms.


• With guidance, conducts experiments to develop robust solid oral dosage formulations and processes.


• Conducts stability studies.


• Manufactures pilot/pivotal, clinical and stability batches to support ANDA filings.


• Supports process optimization, scale-up, technology transfer and process validation


• Other duties as assigned.

Requirements:

• B.A. in non-science discipline, with 2-4 years of pharmaceutical manufacturing experience; or M.S. in non-science discipline, with 0-2 years of pharmaceutical manufacturing experience.


• Knowledge/development of solid dosage formulations preferred.


• Knowledge of manufacturing processes, and knowledge of scale-up and technology transfer to commercial manufacturing site preferred.


• Requires basic knowledge of cGMP.


• Must have basic knowledge and training in using a variety of laboratory and/or scale-up equipment.


• Good communication skills, both verbal and written.