Associate Director, Manufacturing Systems & Automation (CGT)

Role: Associate Director, Manufacturing Systems and Automation for Cell & Gene Therapy (CGT), leading GMP manufacturing systems strategy, implementation, and continuous improvement to support scalable clinical and commercial CGT production. Responsibilities: oversee digital manufacturing initiatives including automation integration, electronic batch records, and product traceability; ensure compliance with GMP regulations (21 CFR Part 11, EU Annex 11, GAMP 5); develop SOPs and metrics for operational excellence; collaborate with IT and Quality to optimize workflows and data integrity; enhance batch review and release processes, particularly for autologous and allogeneic therapies. Requirements: Bachelor’s or Master’s in Engineering, Biotechnology, Automation, or related field; 7-10+ years in GMP manufacturing or automation leadership, with at least 5 years in CGT, biologics, or sterile filling; experience in integrating first-of-kind equipment, digital transformations, and managing GMP training; proficient in manufacturing systems like eBR, DCS/SCADA, Pi, ERP; strong knowledge of regulatory investigations, CAPA, change control. High-Value: Cell & Gene Therapy, GMP manufacturing, digital and automation systems, autologous/allogeneic therapy, regulatory compliance, Boston on-site, senior leadership role.