Manufacturing Practices (cGMP), managing or overseeing the work of more junior QC staff, setting up and maintaining systems for QC laboratory, assist with scheduling, reviewing of tests results, assist in the management of the QC laboratory, participation in assay transfer and validation activities.This position is based in our Milton Park location and typically has a 5-day on-site expectation. Responsibilities

Please Note: We are looking for a Scientist I with tissue culture experience and experience of potency assays in a QC GMP environment.Key responsibilities:Perform QC testing following Standard Operating Procedures (SOPs).Assist with the maintenance of QC laboratory and equipment.Generate protocol and report for assay transfers/validation.Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).Author and review SOPs, forms, Deviations, Change controls CAPA, CoA (Certificate of Analysis) reports Lead or assist with OOS, OOT, and lab investigations as needed.Participate in regulatory inspections and submissions, as needed.Lead QC laboratory equipment introduction and participate in validation activities.Interact within internal as well as across other functional group to communicate QC requirements. Manage receipt and storage of QC samples, reagents and maintain retain inventory.Coordinate shipping of samples to Milton Park

1 Replimune, Inc. jobs in England & Wales