Manufacturing Associate I

Independently executes all routine unit operations in Cell Culture including change-over procedures, scheduling within the shift team, equipment cleaning and set up, CIP, SIP and SIP of Bioreactors up to 12kL. Able to perform in-process testing such as cell counting, and BGA. 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. Technical knowledge of manufacturing systems, methods and procedures. Understanding of purification/cell culture processes. Possess effective troubleshooting skills with equipment and/or process.

Bachelors Degree with a focus in Biopharmaceuticals