The Manager, Quality Control provides oversight of a variety of analytical functions that occur in the QC department supporting validation, testing, and reporting of in-process, release, and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities. The schedule for this role will be Sunday - Wednesday, 10-hour second shift OR Wednesday -Saturday, 10-hour second shift.

Key Duties and Responsibilities: Manages various laboratory program(s)/processes within the department (assay readiness, training, scheduling, data review and reporting) and serves as subject matter expert (SME). Coordinates and facilities laboratory activities to meet commitments on-time Ensure lab personnel have appropriate training. Assist in troubleshooting of analytical methods and/or equipment as required Authors, review, and/or approves data, SOPs, COAs, analytical methods, protocols and reports Monitor, track and publish lab metrics Ensure all laboratory records adhere to cGMP/GDP expectations Leads compliance related teams working towards the goal of continuous improvement Will be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent re-occurrence Provide guidance to reports when issues arise. Coach and develop direct reports. Serves as T1D Cell QC presentative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs

Knowledge and Skills: Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections Preference for background in microbial safety assays such as BACT sterility, gram stain, endotoxin and mycoplasma detection by qPCR. Strong knowledge of analytical methodologies such as flow cytometry, cell-based assays, ELISA, and applying/interpretation of GMP requirements Effective communication skills, both verbal and written Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

Education and Experience: Bachelor's Degree in science or related discipline with 8 + years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience Previous managerial experience (people leader) in a QC or equivalent laboratory setting

Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.