Pioneering Medicines: Executive Director, CMC (Chemistry, Manufacturing & Controls)

Role: Executive Director, CMC (Chemistry, Manufacturing & Controls) at Flagship Pioneering's Pioneering Medicines, leading portfolio-level CMC strategy and execution across multiple emerging modalities. Responsibilities: shape and execute CMC functions including Drug Substance Development, Analytical Development, Regulatory CMC; build and scale high-performing teams; manage external CDMO networks; oversee innovative technology integration, including AI tools; and align cross-functional stakeholders across research, translational medicine, and regulatory. Requirements: PhD with 15+ years in CMC (MS with 18+ or BS with 20+ considered), with senior leadership experience overseeing multiple programs; deep expertise in small molecules, biologics, and advanced modalities like nucleic acids or gene therapies; track record in filing regulatory dossiers and global agency interactions; proven skills in external CMO/CRO management, portfolio risk mitigation, and innovative tech adoption. HighValue: multi-modality portfolio, early to late-stage development, emerging modalities, global regulatory standards (FDA, EMA, PMDA), AI/ML in manufacturing, cross-functional leadership. WorkSetup: not specified; senior leadership role with strategic and operational ownership.