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

Scorpion Therapeutics

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. #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 5 days ago
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