Senior Scientist, Regulatory CMC

Role: Senior Scientist, Regulatory CMC, supporting global regulatory strategies for cell and biologic therapies in ImmunityBio's pipeline. Responsibilities include preparing and reviewing CTD modules (Modules 2 and 3), developing submission strategies, and managing CMC documentation for investigational and marketed products. The role involves interaction with cross-functional teams, assisting with health authority responses, and supporting lifecycle management of CMC modules. Qualifications: Bachelor's in life sciences or related field with 6+ years, Master's with 4+ years, or PhD with 2+ years in regulatory CMC; experience in eCTD submission and response to health authorities; familiarity with biologics, cell therapies, or gene therapies preferred. HighValue: biologics, cell/gene therapy, biologics/biotech, CMC regulatory strategy, eCTD submissions, cross-functional collaboration, Summit, NJ location, on-site work, no travel specified.