Process Development Engineering Principal Associate

Role: Lead Manufacturing Science and Technology activities for cell therapy products, focusing on process development, transfer, and lifecycle management from development to clinical and commercial manufacturing. Responsibilities: oversee process investigations, change controls, continuous improvement initiatives, and support regulatory submissions including IND/IMPD; ensure alignment across cross-functional teams, manage external CDMO activities, and support process validation (pre-PPQ and PPQ); drive operational excellence and process robustness across manufacturing lines. Requirements: PhD in Life Sciences, chemical engineering, or related, or a master's with 2+ years or a bachelor's with 4+ years industry experience; hands-on MSAT investigation and change management expertise, preferably in cell or gene therapy; experience with cell processing, primary cells, and design control; excellent communication, organizational skills, and ability to collaborate across multidisciplinary teams. HighValue: cell/gene therapy, early to late phase clinical or commercial, process development, process validation, CDMO oversight. WorkSetup: on-site five days a week with some flexibility.