Manufacturing Associate

· The Manufacturing Associate will contribute to the Downstream Manufacturing group within the brand new state-of-the art biologics 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.

· Practice a continuous improvement mindset by making suggestions on process improvements.

· At minimum, an Assoc. degree in biology, chemistry or a related scientific or technical area.

· 2 to 4 years of experience within cGMP manufacturing.

· Ability to work in fast paced, dynamic environment.

· 3-5 years hands on experience with Purification equipment such as columns, TFF, filling.

· Experience with buffer solution preparations within a cGMP environment.

· Experience with TrackWise for performing change controls, deviations.

· Strong background in aseptic technique and microbial controls.

· Experience with process development, tech transfer and optimization a plus.

· Strong understanding of cGMP’s as applicable to biologic operations.

· Good analytical skills to interpret and understand purification equipment and data.

· Excellent oral and written communication skills.

· Ability to stand, walk, bend and reach for long periods of time.

· Ability to work flexible working hours.

· Effectively manages time and must pay attention to detail.

· Ability to lift and push up to 30 pounds or more.

· Must be able to read, interpret, and follow SOP’s, batch documents and other procedures.

Christie Mathew 

christie @irionline.com

7328448739