Director, CMC External Manufacturing

Praxis Precision Medicines, Inc.

1d • $210,000 - $235,000 • Remote

About The Position

The Director, External Manufacturing (CMC) will lead and manage outsourced manufacturing operations supporting Praxis’s clinical and future commercial programs. The role oversees CDMOs responsible for drug substance (API) and drug product manufacturing, ensuring high-quality, compliant, and timely clinical material supply. The position calls for a strategic, hands-on CMC leader experienced in managing external partnerships and driving operational excellence in a dynamic biotech environment. It may be performed remotely and requires flexibility and willingness to travel as needed.

Requirements

• 15+ years of progressive CMC or manufacturing experience in the biopharmaceutical industry.
• At least 8 years managing external manufacturing relationships.
• Experience managing global CMC supply chains for commercial products in a regulated environment.
• Strong understanding of GMP, GDP, and ICH guidelines and their application in a commercial setting.
• Experience overseeing both drug substance and drug product manufacturing at clinical and/or commercial scale.
• Excellent negotiation and vendor management abilities, including experience working with CMOs and managing third-party relationships.
• Ability to manage complex projects and external relationships with technical and business acumen.
• Ability to navigate complex regulatory and compliance requirements.
• Regular use of a computer, devices, or other office equipment; clear communication; occasional movement; comfort with screen work, basic hand coordination, and sustained focus.

Nice To Haves

• Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.

Responsibilities

• Lead the strategy, selection, and management of CDMOs for 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 Quality and Technical Agreements with manufacturing partners.
• Manage and optimize end-to-end supply chain activities, including raw materials procurement, production planning, logistics, inventory management, and distribution.
• Lead supplier qualification, monitoring, and performance evaluations; address risks and identify improvement opportunities.
• Negotiate contracts and pricing agreements with suppliers and CMOs to achieve cost-effective outcomes while maintaining supply security.
• Collaborate with Process Chemistry, Formulation, Analytical, Quality, and Regulatory teams to execute 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 outsourced manufacturing complies with appropriate GMP and regulatory standards.
• Implement KPIs and governance mechanisms to monitor and improve CDMO performance.
• Identify and mitigate technical and operational risks across the external supply network.
• Drive operational excellence and process improvements to enhance efficiency and compliance.

Benefits

• Medical, dental, and vision plans with 99% of premiums paid.
• Company-paid life insurance, AD&D, and disability benefits.
• Voluntary plans to personalize coverage.
• Dollar-for-dollar 401(k) match up to 6% of eligible contributions.
• Long-term stock incentives and an employee stock purchase plan (ESPP).
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.

What This Job Offers

• Job Type: Full-time
• Career Level: Director