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

Role: Executive Director, CMC at Flagship Pioneering's Pioneering Medicines, responsible for defining and executing portfolio-level CMC strategies across emerging modalities from research through clinical development. Responsibilities: lead CMC functions including Drug Substance, Drug Delivery, Analytical Development, and Regulatory CMC; build and scale a high-performing, innovative CMC organization; oversee external CDMO partnerships and technology adoption (including AI tools); manage risk, budgets, and portfolio timelines; influence cross-functional stakeholders; ensure compliance with global regulatory standards; and develop pathways for novel modalities. Requirements: PhD in a relevant scientific discipline with 15+ years of CMC experience (or MS with 18+ or BS with 20+), with at least 5 years in senior leadership overseeing multiple programs; expertise in small molecules, biologics, and advanced modalities like nucleic acids or gene therapies; proven record in regulatory filings (INDs, BLAs/NDAs); extensive experience managing CDMOs and implementing innovative technologies; strong understanding of AI/ML and data-driven manufacturing; excellent leadership, strategic thinking, and communication skills. HighValue: senior leadership in CMC for biotech or pharma companies, with a focus on multi-modality pipelines, emerging therapies, and global regulatory engagement. WorkSetup: Not specified.