Executive Director, Batch Release
Celldex
August 24, 2026
Full-time
Remote friendly (Hampton, NJ)
Worldwide
Operations
Role: Executive Director leading batch release and product disposition for commercial biologics, ensuring GMP compliance and quality standards. Responsibilities: oversee final product release decisions, manage CDMO relationships, support quality systems, and develop metrics to enhance performance across commercial and late-stage clinical programs. Collaborates with Quality, Operations, Manufacturing, Supply Chain, and Regulatory teams to ensure timely, compliant product release. Qualifications: Bachelor's in Biology, Microbiology, Chemistry, or related; 15+ years in Quality Assurance within biotech/pharma manufacturing; 8+ years in leadership roles managing quality operations and GMP activities; extensive experience with biologics, monoclonal antibodies, or complex biologics; proven expertise in batch disposition and lot release; experience managing global manufacturing and testing networks. HighValue: biologics manufacturing, GMP compliance, commercial product release, managing CDMOs, global manufacturing oversight, leadership in quality assurance. WorkSetup: not specified; likely hybrid or on-site depending on operations.