Associate Director, Manufacturing Systems & Automation (CGT)
Core
Lead the design, implementation, and lifecycle management of GMP manufacturing systems and automation platforms for scalable clinical and commercial cell and gene therapy operations.
Role type
Associate Director, Manufacturing Systems & Automation (CGT)
Builds
Digital manufacturing initiatives including manufacturing execution systems, automation integration, electronic batch records, and end-to-end product traceability for patient-specific autologous therapy.
Domain
Biopharmaceutical Sciences – Cell & Gene Therapy (CGT) Manufacturing and Process Engineering
Deliverable
production ML models | product features | infrastructure
Required skills
GMP manufacturing leadership, digital transformation strategy, SCADA/MES/LIMS/OSI Pi/eBR system integration, regulatory compliance (FDA 21 CFR Part 11, EU Annex 11, GAMP 5), cross-functional team leadership, operational excellence, data integrity management.
Preferred skills
Commercialization experience with first-of-kind equipment, automated batch review by exception, release by exception, chain-of-custody systems.
Technologies
SCADA, MES, LIMS, OSI Pi, eBR, DCS, ERP, QMS
Responsibilities
Lead design and lifecycle management of GMP manufacturing systems; develop digital manufacturing strategies for real-time execution and analytics; drive deployment of automation and smart manufacturing initiatives; partner with IT and QA on exception management workflows; ensure regulatory alignment and inspection readiness; develop governance standards and SOPs; track KPIs for operational efficiency.
Seniority
Senior, hands-on IC with strategic leadership
