Quality Control Manager - Cell Therapies

Key Duties and Responsibilities Manage laboratory program(s)/processes (assay readiness, training, sample management, data review and reporting) and serve as QC contact/representation for Quality Events. Coordinate and facilitate laboratory activities to meet on-time commitments. Ensure lab personnel have appropriate training. Assist in troubleshooting analytical methods and/or equipment. Author, review, and/or approve data and SOPs. Monitor, track, and publish lab metrics. Ensure laboratory records adhere to cGMP/GDP expectations. Lead sub-teams focused on continuous improvement. Lead OOS/OOT investigations/deviations and identify corrective actions to prevent recurrence (as required). Provide guidance to reports; coach and develop reports. Serve as T1D Cell QC representative in cross-functional teams and/or with outside vendors. Knowledge and Skills Strong knowledge of US/EU cGMP regulations/guidance; some regulatory agency inspection experience. Strong knowledge of analytical methodologies: flow cytometry, cell-based assays, qPCR, ELISA, BACT, endotoxin; applying/interpretation of GMP requirements. Effective verbal and written communication. Ability to prioritize across projects, meet timelines with attention to detail. Education and Experience Bachelor’s degree in science or related discipline required; 8 years of pharmaceutical/biopharmaceutical industry experience (or equivalent combination of education/experience). Pay Range $117,800 - $176,800 Flex Designation On-Site (five days per week on-site with ad hoc flexibility). #J-18808-Ljbffr