Project Specialist I, Manufacturing

Role: Project Specialist I in Manufacturing supporting technical documentation, quality records, training, process improvements, and compliance within GMP biopharma manufacturing, particularly in cell/gene therapy. Responsibilities: manage deviations, CAPAs, change controls, and SOPs; oversee short-term manufacturing scheduling, technician resource planning, and workforce alignment; coordinate technician training, onboarding, and qualification tracking; drive operational efficiency through continuous improvement initiatives; facilitate cross-functional communication between manufacturing, supply chain, and project teams. Requirements: Bachelor's degree with 3+ years (or Master's with 1+ year) experience in GMP or manufacturing environment; experience in autologous gene/cell therapy manufacturing preferred; strong skills in manufacturing scheduling, resource planning, and proficient in Excel, SAP, Veeva; knowledge of GMP quality systems. HighValue: experience in cell/gene therapy, autologous manufacturing, GMP compliance, and technical operations; focus on workforce and process optimization in fast-paced biopharma setting. WorkSetup: on-site with physical requirements for routine GMP manufacturing activities.