A global cell-therapy organization is looking to add a Quality Control Manager to lead their actively growing Quality Control Team! With the cell-therapy market on the rise, this is a great opportunity to get in with an organization that is growing and has wonderful things on the horizon!
- Responsible for performing Cell Biology, Biochemistry, and Safety assays in support of the production, release, and distribution of Cell Therapy products
- Works in cooperation with the Technical Services and Bio Analytical Services groups to ensure client methods are adequately qualified/validated and successfully transferred into the QC lab for use in support of Cell Therapy Operations
- Develops and maintains a tool for monitoring QC resource capacity. Provides feedback to QC management and production planners when capacity constraints exist. Testing includes manual and automated cell counts, hematology analysis, and flow cytometry
- Collaborates with QC Technical Services group, Bio Analytical Services team, MSAT, and program management to drive technical transfer, staff training, and assay qualification/validation activities.
- Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA). Actively works to ensure responses are completed on-time. Escalates roadblocks to completion and provides potential solutions.
- Prepares monthly management reports including budget analysis and project updates. Actively monitors spending for area. Predicts and escalates potential spending variances. Identifies corrective actions for spending variances.
- Bachelor's degree
- Responsible for cost center budget development, monitoring, and escalation of variances
- Working knowledge of LIMS, SAP and TrackWise a plus
- Demonstrated knowledge in biological, cell-based assays including flow cytometry and PCR.
- Experience with method validation and technology transfer preferred.
- Develops training plans and performs identification and remediation of training gaps