Director, Manufacturing

Oversee drug product manufacturing operations at the Framingham facility, defining aseptic processes and maintaining environmental monitoring systems for sterile quality assurance. Lead risk management efforts to establish cross-contamination and particulate control strategies while managing daily activities, including batch record creation, execution, and revision for formulation and filling. Collaborate with Operations, Engineering, and Validation teams to ensure equipment calibration, support investigations and CAPA closures, and drive continuous improvement through new technology deployment. Manage staff hiring and development to ensure commercial readiness for product launch, while representing the organization in industry forums to shape aseptic regulations. Prioritize safety compliance with OSHA standards and foster a culture of cross-functional collaboration across the manufacturing suite.