Director, Operations
Core
Lead operations for a new high-potency biologics manufacturing facility, ensuring GMP compliance, efficient production of sterile drug products (e.g., ADCs), and strategic project realization.
Role type
Director, Operations (Drug Product Manufacturing)
Builds
Commercial and clinical biologics (sterile drug products, antibody drug conjugates)
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, sterile manufacturing, high-potency product handling, cross-functional project management, Lean manufacturing, operational leadership, financial forecasting, digital tools for operations, KPI monitoring
Preferred skills
Multi-product sterile manufacturing leadership, high-performance culture building, innovative problem-solving, cross-organizational influence
Technologies
Digital tools for operational efficiency
Responsibilities
Shape site and organizational strategies for facility start-up and commercial production; oversee drug product manufacturing for new product introductions; streamline technology transfers and commercial approvals; foster continuous learning and improvement culture; champion operational excellence and process optimization; manage quality topics and inspection readiness; oversee financial forecasts and cost reduction initiatives; monitor and improve performance metrics (hiring, uptime, yield, production cadence)
Seniority
Director, strategic leadership & hands-on operations
