Our growing Gene Therapy client is expanding and adding a Director, Virology QC to their team! They are based in Cambridge, MA and the role will move out to the Waltham, MA area to help build out a new, state of the art lab! This role will build, review and trend development, GMP and stability data, generating reports as necessary to document these activities. The Director of QC will also support the development and implementation of GMP quality systems to ensure that company is in compliance with US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials by authoring appropriate SOPs and implementing training programs to support QC and related GXP processes. The Director of QC- Virology will specifically support the gene therapy program pipeline including but not limited to oversight and management of technical transfer, method qualification and/or validation and routine GMP testing of AAV vector and AdV analytical methods (qPCR, TCID50, and other methods as needed) and support viral clearance studies. The Director will manage external laboratory testing and internal study protocol design, study report review and IND support as needed.
Ensure successful technical transfer, method qualification, troubleshooting and routine GMP testing for qPCR, cell-based infectivity, and virus detection assays. Engaging with in-house teams and external QC test labs and CMOs, oversee and manage: QC data review, method validation activities, protocol review and report finalization.