Senior Process Engineer, MS&T

Role: Senior Process Engineer in Manufacturing Science & Technology at Rocket Pharma, focusing on AAV gene therapy development, commercialization, and lifecycle management. Responsibilities include supporting GMP manufacturing, process validation, deviations, investigations, change controls, and lifecycle activities such as CPV and APQR. The role leads validation documentation for PPQ, conducts root cause analyses, and collaborates cross-functionally with Manufacturing, Process Development, and Quality teams to ensure technical and regulatory compliance. Requirements: PhD (2+ years), MS (6+ years), or BS (8+ years) in a relevant field with experience in late-stage drug development; gene therapy experience preferred. Proven ability in process validation, cGMP compliance, and CTD documentation is essential. Preferred skills include experience with viral vectors or biologics, process improvements, and working in a fast-paced, results-oriented environment. HighValue: gene therapy (AAV vectors), late-stage GMP manufacturing, process validation, process transfer, and lifecycle management. WorkSetup: not specified, but involves collaboration across multiple departments and external partners.