Mfg Operations Associate Director - Biologics, Drug Substance

Role: Associate Director, Technical Services, lead for biologics drug substance manufacturing at external partners, ensuring process execution, performance, and supply reliability. Responsibilities: provide technical leadership during manufacturing campaigns, oversee deviation resolution, coordinate cross-functional teams (MSAT, Quality, Manufacturing), monitor batch performance, implement process improvements, and lead change management. Requirements: BS/BA in Biological Sciences, Chemical Engineering, or related; 10+ years in biologics manufacturing, MSAT, or external manufacturing with experience in cGMP operations, deviation management, troubleshooting, and leading technical teams. Preferred: advanced degree, prior experience with external manufacturing partners, leadership in biotech/pharma, strong communication skills, project management expertise. High-Value: biologics (likely monoclonal antibodies or similar modalities), drug substance manufacturing, external/CDMO partnerships, cGMP compliance, technical troubleshooting, process optimization, shift work, up to 30% travel. Work setup: hybrid or on-site; flexible working options.