Purification Associate / Manufacturing Associate

· 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.

Regards,

Indu Dubey
Clinical Recruiter
732-844-8725

indu @irionline.com