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Senior Director, Pharmaceutical Development

Maze Therapeutics - South San Francisco, CA

Posted Apr 8, 2026

Benefits

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About this role

Senior Director, Pharmaceutical Development South San Francisco, CA The Opportunity As Senior Director of Pharmaceutical Development, you lead all small molecule drug product activities and serve as a technical expert overseeing processes at CDMOs. You guide formulation and process development, manage scaleups, and proactively identify risks, gaps, and solutions across CMC. You'll dig into process and analytical data to resolve key challenges and advise on the best path forward. You bring strong cGMP expertise, support regulatory submissions, and collaborate across research, development, and technical operations. You coach teams for excellence, fuel intellectual curiosity, and champion inclusive, impactful leadership. This position reports to Vice President, Technical Operations. The Impact You'll Have - Lead small molecule drug product formulation, process development, and manufacturing activities with external CDMOs. - Ensure drug products meet quality, cost, time, safety, and operational goals. - Evaluate CDMO capabilities and recommend approaches for development and manufacturing. - Drive formulation, process development, scaleup, and tech transfer from initiation through regulatory approval. - Shape and optimize CMC strategy, project plans, and execution. - Monitor daily CMC activities, resolve challenges, and ensure cGMP compliance. - Ensure CDMO processes meet needs across formulation development, tox studies, clinical trials, and commercial launch. - Assess and implement new methods, tools, and technologies that elevate program success. - Analyze scientific data, review batch documentation, and contribute to regulatory filings (IND/IMPD/CTA/NDA). - Review and approve master and executed batch records; lead process improvements and drive solutions. - Lead technical investigations, identify root causes, and implement corrective

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