Day-to-Day Responsibilities
Study the chemistry and steps of a drug product and design the process for making it at plant scale.
Scale up a process from lab bench to pilot batch to commercial production, adjusting temperature, pressure, mixing and timing.
Set up and troubleshoot production equipment such as reactors, granulators, dryers, mixers, filters and tablet presses.
Prepare and review batch manufacturing records, standard operating procedures and process documents.
Work with quality assurance on process validation, deviations, change controls and audits.
Monitor process data, find yield losses or quality issues, and lead root-cause analysis and improvements.
Coordinate with production, maintenance, R&D and technology transfer teams to move a product into a new plant.
