Manufacturing Associate

divh2Manufacturing Associate/h2pThe Manufacturing Associate will contribute to the Downstream Manufacturing group within the brand new state-of-the-art biologics manufacturing facility./ppWe are seeking a highly self-motivated person willing to contribute to the development, qualification, and eventual operation and overall success of downstream operations./ppThis 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./ppAssist in developing procedures (SOPs Master Batch Records) for the Manufacturing Downstream group./ppComplete assigned tasks associated with Purification operations and assist in execution of operations such as column chromatography, TFF, CIP, column packing./ppAbility to work independently to develop and write documentation associated with Purification./ppAssist in troubleshooting equipment or process issues./ppInitiate and complete deviations, change controls, investigations, as assigned using TrackWise or any similar software system./ppCompliance to safety guidelines and current Good Manufacturing Practices (cGMP)./ppAbility to train other associates and willing to be involved in cross-training in other groups, as required./ppFollow standard operating procedures./ppAbility to lead the purification operations./ppAssist in Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and other validation needs such as IOQ and PQ./ppAbility to multi-task and work well with the team./ppCompletes all training documentation within a defined time-frame./ppAnalyze in process samples generated from purification activities by using pH/conductivity meters, scales, spectrophotometers etc./ppPerforms review of the manufacturing documentation of the associated area./ppOther duties as assigned./ppPractice a continuous improvement mindset by making suggestions on process improvements./ph2Qualifications/h2pAt minimum, an Assoc. degree in biology, chemistry or a related scientific or technical area./pp2 to 4 years of experience within cGMP manufacturing./ppAbility to work in fast paced, dynamic environment./pp3-5 years hands on experience with Purification equipment such as columns, TFF, filling./ppExperience with buffer solution preparations within a cGMP environment./ppExperience with TrackWise for performing change controls, deviations./ppStrong background in aseptic technique and microbial controls./ppExperience with process development, tech transfer and optimization a plus./ppStrong understanding of cGMPs as applicable to biologic operations./ppGood analytical skills to interpret and understand purification equipment and data./ppExcellent oral and written communication skills./ppAbility to stand, walk, bend and reach for long periods of time./ppAbility to work flexible working hours./ppEffectively manages time and must pay attention to detail./ppAbility to lift and push up to 30 pounds or more./ppMust be able to read, interpret, and follow SOPs, batch documents and other procedures./p/div