Senior Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Operations
Core
Leading technology transfer, process validation, and continuous improvement for end-to-end cell therapy manufacturing processes to enable commercialization and lifecycle management.
Role type
Senior Process Engineer (Cell Therapy Manufacturing)
Builds
Robust, compliant, and cost-effective cell therapy manufacturing processes
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Required skills
Cell therapy manufacturing processes, Technology transfer, Process validation, Continued Process Verification (CPV), CMC regulatory submissions, GMP compliance, Process characterization, Change control management, Supply continuity planning, Risk mitigation
Preferred skills
Viral vectors experience, Vaccines experience, Biologics experience, CMO management experience
Technologies
GMP, ICH guidelines, CMC sections, INDa, BLA, MAA
Responsibilities
Represent Global MSAT in technology transfer and process characterization teams; Develop PPQ readiness and execution technical framework; Implement proactive process analysis and CPV strategies; Provide technical oversight across manufacturing lifecycle from transfer to post-approval; Lead global Change Controls; Contribute to authoring CMC sections of regulatory submissions
Seniority
Senior, hands-on IC