Associate Director, External Manufacturing (CMC)

Praxis Precision Medicines, Inc.

4d • $170,000 - $190,000 • Remote

About The Position

The Associate Director, External Manufacturing (CMC) will support 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.

Requirements

• Advanced degree preferred in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; bachelor’s degree with extensive relevant experience considered.
• 10+ years of progressive CMC or manufacturing experience within the biopharmaceutical industry, including ≥8 years managing external manufacturing relationships.
• 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 or commercial scale.
• Excellent negotiation and vendor management abilities including experience working with CMOs and managing third-party relationships.
• Proven ability to manage complex projects and external relationships with technical and business acumen.
• Ability to navigate complex regulatory and compliance requirements.

Responsibilities

• Support developing 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.
• 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.
• 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.

Benefits

• 99% of the premium paid for medical, dental and vision plans.
• company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
• dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP
• discretionary quarterly bonus
• extremely flexible wellness benefit
• generous PTO
• paid holidays and company-wide shutdowns

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees