Process Engineer, Cell Therapy Process Development

Role: Process Engineer supporting late-stage cell therapy process development and characterization, focusing on unit operations such as T-cell enrichment, activation, transduction, washes, and harvest. Responsibilities include optimizing and validating scalable, closed-system processes, conducting DOE and multivariate studies per QbD/ICH guidelines, analyzing data with digital and AI tools, and supporting tech transfer, PPQ batches, and manufacturing readiness. Collaborates with analytical and manufacturing teams, supporting lifecycle management and continuous process improvements. Qualifications: MS in Chemical/Biochemical Engineering or related with 2+ years (or B.S. with 7+ years) industry experience; expertise in cell therapy operations or biologics; GMP experience in late-stage or commercial manufacturing; strong data analysis, technical writing, and problem-solving skills. Preferred skills include automation platform familiarity (e.g., CliniMACS Prodigy), digitalization, and statistical analysis tools like JMP. High-Value: cell therapy, late-stage development, process characterization, automation, AI/ digital tools, GMP compliance, cross-functional collaboration. Work setup: hybrid; travel not specified.