Independently executes all routine unit operations in Purification including change-over procedures, scheduling within the shift team, equipment cleaning and set up. Able to perform in-process testing such as cell counting, spectrophotometry and environmental monitoring. Monitors and controls weights, flows, volumes, temperatures, pressure, and pH. Identify and report any issues related to manufacturing performance, process and safety to the team lead and assist in investigations of deviations in order to facilitate continuous process improvement. Train junior staff on unit operations such as bioreactors, cell separation, chromatography and tangential flow theory as well as CIP/SIP operations. All training will be conducted with an emphasis on safety and completion of operations in a timely manner. Collaborates within team and department in order to follow best practices and meet department goals. Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.
Experience working with established GMP procedures and bulk manufacturing is a plus. Technical knowledge of manufacturing systems, methods and procedures. Understanding of purification/cell culture processes. Possess effective troubleshooting skills with equipment and/or process.
Preferred, associates degree with (1) year closely related technical experience, preferably in a pharmaceutical or chemicals manufacturing environment;
Last updated on Jan 23, 2023