Title: Sr. Manager/Associate Director, QC Analytical Services
Location: Bedford, MA (Hyrbid)
A pharmaceutical company specializing in gene therapy is looking to build out their team as they continue to grow. They are looking for a Sr. Manager or Associate Director level candidate to be responsible for the QC departments analytical method lifecycle, including method qualification, transfer, validation, performance monitoring, and continuous improvement.
- Oversight of qualification, transfer, validation, and verification of analytic methods (ddPCR, ELISA, HPLC, cell-based assays)
- Provide SME support for method transfer, qualification, and validation activities
- Monitoring of on-going analytical method performance and drive continuous improvement
- 10 years' experience in the pharmaceutical or biotech industry
- SME experience with ddPCR, qPCR, or cell based assays
- Extensive experience with method qualification, transfers, validation, and lab investigations
If you would like to hear more, please don't hesitate to apply!