Senior Director, Manufacturing Operations - Site Based, Redmond, WA

Role: Lead manufacturing operations for late-stage clinical and commercial biologics, focusing on cell culture, purification, and media preparation using disposable-based technologies. Responsibilities: oversee day-to-day cGMP-compliant manufacturing, troubleshoot technical issues, ensure staff training, participate in commissioning/validation, maintain quality systems, and support regulatory inspections. Requirements: Bachelor's in biological or engineering sciences, 15+ years of relevant experience, deep technical expertise in biologics manufacturing, strong knowledge of cGMP, equipment, and engineering principles, and leadership skills in managing large teams. Preferred: familiarity with process automation (e.g., DeltaV), validation processes, and US/EU regulatory standards (FDA CFRs, EMA, ICH). High-value: biologics (likely monoclonal antibodies or other large molecules), late-stage clinical and commercial phases, disposable technology, site-based with a focus on quality and compliance, involved in validation, commissioning, and regulatory support. Collaboration: leading manufacturing team, providing technical guidance, ensuring compliance with cross-disciplinary standards. Work setup: site-based, no explicit travel requirements stated.