·The Manufacturing Associate will contribute to the Downstream Manufacturing group within the brand new state-of-the art biologic manufacturing facility.
·We are seeking a highly self-motivated person willing to contribute to the development, qualification, and eventual operation and overall success of downstream operations.
·This includes but is not limited to column packing, column chromatography and tangential flow filtration (TFF) and aseptic filling operations for proprietary and biosimilar biologics pipeline.
·Assist in developing procedures (SOP’s & Master Batch Records) for the Manufacturing Downstream group.
·Complete assigned tasks associated with Purification operations and assist in execution of operations such as column chromatography, TFF, CIP, column packing.
·Ability to work independently to develop and write documentation associated with Purification.
·Assist in troubleshooting equipment or process issues.
·Initiate and complete deviations, change controls, investigations, as assigned using TrackWise or any similar software system.
·Compliance to safety guidelines and current Good Manufacturing Practices (cGMP).
·Ability to train other associates and willing to be involved in cross-training in other groups, as required.
·Follow standard operating procedures.
·Ability to lead the purification operations.
·Assist in Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and other validation needs such as IOQ and PQ.
·Ability to multi-task and work well with the team.
·Completes all training documentation within a defined time-frame.
·Analyze in process samples generated from purification activities by using pH/conductivity meters, scales, spectrophotometers etc.
·Performs review of the manufacturing documentation of the associated area.
·Other duties as assigned.