💼 About This Role

You'll lead portfolio-level CMC strategy across multiple emerging modality programs at Pioneering Medicines, an initiative of Flagship Pioneering. Your core impact will be building the CMC function as a competitive advantage by defining strategy, managing a best-in-class CDMO network, and championing AI-enabled tools. This role reports to the SVP of CMC Technical Operations and operates at the intersection of science, strategy, and operations.

🎯 What You'll Do

• Lead CMC functions including Drug Substance Development, Analytical Development, and Regulatory CMC
• Build, scale, and define strategic direction of the CMC organization
• Manage external CDMO network selection, assessment, and strategic relationships
• Oversee identification and implementation of novel technologies including AI-driven tools
• Engage stakeholders across Technical Operations, Research, and Regulatory Affairs

📋 Requirements

• PhD in a relevant scientific discipline with 15+ years of progressive CMC experience
• Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple programs
• Deep hands-on expertise in small molecules and biologics
• Track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs)

✨ Nice to Have

• Expertise in advanced modalities (nucleic acids, cell or gene therapies)
• Experience with AI/ML and digital process development tools

🎁 Benefits & Perks

• 💡 Pioneering environment at a leading biotech innovation hub
• 🚀 High-impact leadership shaping multimodality pipeline
• 🌐 External network management with top CDMOs

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter screen· 45 min
2. 2Technical interview with SVP· 60 min
3. 3Executive panel· 90 min