Director, Gene Therapy Manufacturing, Drug Su

Role: Director of Gene Therapy Manufacturing, Drug Substance, leading technical operations for clinical and commercial biologics production. Responsibilities: oversee manufacturing teams across production, quality, and materials; manage operational planning, schedule adherence, and real-time issue resolution; ensure compliance, safety, and quality standards; drive continuous improvement using Lean tools; develop staffing and leadership capabilities; coordinate site expansion and process scale-up in collaboration with MS&T. Qualifications: Bachelor's in Biology, Chemistry, or Chemical Engineering; 10+ years in cGMP biologics manufacturing; 5+ years in leadership roles within production or technical operations; strong knowledge of regulatory standards, quality systems, and operational planning; proven experience in site ramp-up, deviation management, and project execution. Preferred: Master’s degree, Lean Six Sigma, ERP/MRP experience (Oracle, SAP), and technical manufacturing expertise. High-Value: biologics (gene therapy focus), cGMP, biologics manufacturing, process scale-up, site expansion, compliance, and continuous improvement. Work setup: onsite full-time; periodic weekend/shift work and on-call support.