Director, QC Automation

Role: Director of QC Automation responsible for deploying and managing Automated QC (AQC) systems across the Cell Therapy manufacturing network. Objectives include ensuring reliable system deployment, lifecycle management, and compliance with cGMP standards. Responsibilities: own technology roadmap for AQC equipment/software, lead deployment at multiple sites, coordinate with Assay and Data Automation (ADA) and Analytical Sciences & Technology (AS&T), serve as primary contact for receiving sites, and support regulatory filings. Qualifications: 12+ years in regulated pharmaceutical or biotech manufacturing, with 5+ years leading automation or tech transfer projects. Deep knowledge of cGMPs, pharmaceutical regulations, and automated analytical technologies required. Skills in cross-functional leadership, stakeholder management, problem-solving, and risk mitigation are essential. High-Value: biologics or cell therapy manufacturing, automation systems deployment, technology lifecycle ownership, and cGMP compliance. Work setup involves overseeing multiple sites, with occasional travel up to 25%, centered in Devens, MA, or other US locations.