Director, CMC External Manufacturing

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity The Director, External Manufacturing (CMC) will lead and manage outsourced manufacturing operations supporting Praxis’s clinical and future commercial programs. This role will oversee Contract Development and Manufacturing Organizations (CDMOs) responsible for drug substance (API) and drug product manufacturing, ensuring high-quality, compliant , and timely supply of clinical materials. The ideal candidate is a strategic, hands-on CMC leader experienced in managing external partnerships and driving operational excellence in a dynamic biotech environment. Primary Responsibilities External Manufacturing Oversight Lead the strategy, selection, and management of CDMOs for both drug substance and drug product manufacturing. Serve as the primary operational interface between Praxis and external manufacturing partners. Oversee technology transfer, process scale-up, validation, and clinical supply readiness. Establish and maintain robust Quality and Technical Agreements with manufacturing partners. Manage and optimize the end-to-end supply chain process, including raw materials procurement, production planning, logistics, inventory management, and distribution. Lead supplier qualification, monitoring, and performance evaluations, addressing risks and identifying opportunities for improvement. Negotiate contracts and pricing agreements with suppliers and CMOs to achieve cost-effective outcomes while maintaining supply security. CMC Operations and Program Support Collaborate closely with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams to ensure seamless execution of CMC deliverables. Support CMC development strategies aligned with clinical timelines, regulatory expectations, and company objectives. Manage manufacturing planning, scheduling, and inventory to ensure uninterrupted clinical supply. Governance, Compliance, and Continuous Improvement Ensure all outsourced manufacturing is performed under appropriate GMP and regulatory standards. Implement key performance indicators (KPIs) and governance mechanisms to monitor and improve CDMO performance. Proactively identify and mitigate technical and operational risks across the external supply network. Drive operational excellence and process improvements to enhance efficiency and compliance. Qualifications and Key Success Factors Advanced degree preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; bachelor’s degree with extensive relevant experience considered. 15+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry, including ≥8 years managing external manufacturing relationships. 10+ years of small molecule experience. Proven experience in managing global CMC supply chains for commercial products in a regulated environment. Includes strong understanding of GMP, GDP, and ICH guidelines and their application in a commercial setting. Demonstrated experience overseeing both drug substance and drug product manufacturing at clinical and/or commercial scale. <li