Director, Product Quality Leader

Job Description: Allogene is seeking a Product Quality Leader (PQL) to oversee Allogene's CAR T programs, including starting materials (cell starting materials, viral vectors, and nucleic acids programs). Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The role will entail oversight and coordination of Quality related activities associated with drug substance/drug product manufacturing internally or at contract manufacturing organizations (CMO) for clinical and future commercial use, including but not limited to testing, stability studies, standards and controls, discrepancies/Out Of Specifications (OOS)/CAPA management, and comparability studies. The individual will be responsible for providing analytical expertise and technical oversight supporting method validations, product characterization and process qualification activities. As the representative of the Quality organization on CMC teams, ...