Director - Commercial Manufacturing Operations

Praxis Precision Medicines, Inc.

1d • $209,000 - $229,000 • Remote

About The Position

Praxis partners with external manufacturers to produce life-changing medicines for patients with central nervous system disorders. This role exists to ensure those partners operate with the same urgency, quality, and accountability that we expect from ourselves. As Director, Commercial Manufacturing Operations, you will serve as the operational leader for commercial manufacturing of an assigned product. Acting as Praxis's "virtual plant manager," you will own day-to-day manufacturing performance across one or more CDMO partners, ensuring reliable supply, operational excellence, and continuous improvement throughout the commercial lifecycle. This is not a project management or technical transfer role. It is an operations leadership role focused on delivering consistent commercial execution through influence, partnership, and disciplined operational management. You'll build strong relationships across Manufacturing, Quality, Supply Chain, MSAT, Procurement, and our external partners to anticipate risks, solve problems quickly, and continuously raise performance standards. Success in this role means patients receive uninterrupted access to medicines because our manufacturing network consistently delivers safe, compliant, high-quality product.

Requirements

• Bachelor’s degree in engineering, pharmaceutical sciences, chemistry or a related discipline; advanced degree preferred, or equivalent experience.
• 15+ years of pharmaceutical or biotechnology manufacturing experience, including significant leadership experience supporting commercial GMP operations.
• Demonstrated experience leading manufacturing operations at a commercial manufacturing site (Plant Manager, Operations Leader, or equivalent operational leadership role).
• Significant experience managing external manufacturing partners (CDMOs) supporting commercial products.
• Strong knowledge of commercial manufacturing operations, GMP regulations, quality systems, deviation management, CAPA processes, and continuous improvement methodologies.
• Demonstrated ability to influence cross-functional teams and external partners without direct reporting authority.
• Excellent communication skills with the ability to translate operational complexity into clear business decisions for senior leadership.

Nice To Haves

• advanced degree preferred, or equivalent experience.

Responsibilities

• Serve as the operational owner for commercial manufacturing performance at assigned CDMO partners, ensuring reliable execution of production schedules, supply commitments, and operational readiness.
• Lead a cross-functional Virtual Manufacturing Team, aligning Manufacturing, MSAT, Quality, Supply Chain, Procurement, Regulatory, and Analytical Development around a common operational plan and clear priorities.
• Develop deep operational visibility into manufacturing performance, proactively identifying staffing, equipment, material, scheduling, and compliance risks before they impact patients or supply.
• Drive operational excellence by establishing meaningful performance metrics, monitoring trends, and partnering with CDMO leadership to improve right-first-time performance, schedule adherence, cycle times, yields, and overall manufacturing reliability.
• Partner closely with Quality to ensure deviations, investigations, CAPAs, change controls, and audit observations are addressed with urgency while maintaining the highest standards of GMP compliance.
• Lead operational response during manufacturing issues, acting as the primary Praxis representative during batch-at-risk events, supply disruptions, or significant operational escalations.
• Champion a culture of continuous improvement by identifying and implementing initiatives that improve operational performance, reduce cost, increase capacity, and strengthen long-term CDMO capabilities.

What This Job Offers

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