Senior Drug Substance Process Engineer
Current•Lead process engineer for equipment and process transfer of new drug substance•Develop process equipment specifications and technical documentation for transferring of new drug substance process with the capabilities of scale up.•Design and space plan for new manufacturing and support spaces with emphasis on lean manufacturing during the concept and design phases.•Provide manufacturing optimization opportunities within the design phase for process simplification.•Conduct design… Show more •Lead process engineer for equipment and process transfer of new drug substance•Develop process equipment specifications and technical documentation for transferring of new drug substance process with the capabilities of scale up.•Design and space plan for new manufacturing and support spaces with emphasis on lean manufacturing during the concept and design phases.•Provide manufacturing optimization opportunities within the design phase for process simplification.•Conduct design of experiments and feasibility studies on prospective equipment.•Define and establish maintenance plans and spare part management for new process and support equipment.•Cross-collaborate with quality, regulatory, manufacturing, engineering and global R&D teams for the technical transfer and site start-up of new drug substance. Show less