Executive Director / Vice President, CMC

Responsibilities

• Serve as a key member of the Technical Operations leadership team. Lead CMC functions including Drug Substance Development, Drug Delivery / Pre-formulation, Analytical Development, Product Development and Regulatory CMC. Accountability for all aspects of CMC functional strategy and portfolio deliverables.
• Own and drive end-to-end CMC execution across an increasing portfolio of multimodality compounds, ensuring programs advance on time and on strategy; accountable for portfolio-level CMC risk identification, prioritization, and mitigation.
• Build and manage a high-performing external CDMO network in partnership with VP, CMC Operations. This includes selection, assessment and establishment of strategic relationships; Maintain a forward-looking view of the CDMO landscape to anticipate portfolio capacity and manufacturing needs.
• Oversee the identification, evaluation, and implementation of novel technologies and innovations to drive greater program / portfolio value. Leverage emerging AI-driven technical development, manufacturing and advanced analytics approaches to accelerate CMC timelines and improve efficiency across the portfolio.
• Engage and align key stakeholders across Technical Operations, Research, Translational Medicine, and Regulatory Affairs to establish CMC development paradigms, resolve cross-functional trade-offs, and ensure portfolio decisions reflect both scientific rigor and operational reality.
• Oversee CMC handoffs and establishing fit-for-purpose development and manufacturing pathways for novel modalities originating within the FSP ecosystem. Act as CMC strategic advisor, as needed.
• Serves as an ambassador of PM for external stakeholders and industry as a whole.

Requirements

• PhD in a relevant scientific discipline with 15+ years of progressive CMC experience (MS with 18+ or BS with 20+ considered); Minimum 5 years in senior leadership with direct accountability for CMC strategy across multiple simultaneous programs
• Deep hands-on expertise in small molecules and biologics. Expertise is preferred (but not required) in advanced modalities incl. nucleic acids, cell or gene therapies
• Demonstrated track record of filing and defending regulatory dossiers (INDs, CTAs, BLAs/NDAs, or MAAs) across multiple programs and modalities; Current working knowledge of global regulatory expectations (FDA, EMA, PMDA) and direct experience in agency interactions on CMC topics.
• Proven ability of owning CMC strategy and execution across a multi-program portfolio simultaneously, including developing and managing CMC budgets, risk management, and delivery against aggressive timelines
• Extensive experience identifying, selecting, contracting, and managing CDMOs and CROs with specialized emerging modality capabilities, including leading technology transfer and resolving technical challenges at external sites
• Thought leadership in innovation, including novel delivery, high-throughput process development, and platform-based approaches to elevate program / portfolio value
• Strong understanding of AI/ML, digital process development tools, and data-driven manufacturing platforms to improve development speed and efficiency
• Executive presence and demonstrated ability to influence and align cross-functional PM and platform company leaders; Strong communicator who can translate complex CMC strategy and risk for non-specialist audiences
• Experience partnering with GxP Quality to establish quality systems appropriate for a development-stage organization, including SOPs, change control, and deviation management in a GxP environment
• Entrepreneurial builder energized by creating structure in ambiguous, fast-moving environments; high accountability orientation with a bias for action and the ability to make sound decisions with incomplete information
• Collaborative, low-ego leadership style with genuine investment in team development and cross-functional relationships