Executive Director, CMC

Responsibilities

• Lead CMC functions including Drug Substance Development, Analytical Development, Product Development, and Regulatory CMC.
• Build and scale the CMC organization, including recruiting, developing, and retaining a high-performing team.
• Drive end-to-end CMC execution across a multimodality portfolio, ensuring programs advance on time and on strategy.
• Build and manage a strategic external CDMO and CRO network to support portfolio capacity and manufacturing needs.
• Oversee the implementation of novel technologies and AI-driven technical development to accelerate CMC timelines.
• Align with stakeholders across Research, Translational Medicine, and Regulatory Affairs to resolve cross-functional trade-offs.

Requirements

• PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ years considered).
• Minimum of 5 years in a senior leadership role with direct accountability for CMC strategy across multiple programs.
• Deep technical expertise in both small molecules and biologics.
• Proven track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs).
• Extensive experience in identifying, selecting, and managing CDMOs and CROs, including technology transfer.
• Strong understanding of GxP Quality systems and experience partnering with Quality to establish SOPs and change control.
• Ability to operate in an entrepreneurial, fast-moving environment with a bias for action.

Preferred Qualifications

• Expertise in advanced modalities including nucleic acids, cell, or gene therapies.
• Experience leveraging AI/ML and digital process development tools to improve manufacturing efficiency.
• Demonstrated experience in agency interactions regarding CMC topics (FDA, EMA, PMDA).

About the Company

Pioneering Medicines is an initiative of Flagship Pioneering, focused on developing life-changing treatments by harnessing the power of scientific platforms. We combine innovative approaches to address serious diseases with unmet medical needs, building a world-class biopharmaceutical R&D capability.