Director, Commercial Manufacturing Operations

About the role

Location: This position may be performed remotely but requires flexibility and a willingness to travel (approximately 40-60%) to CDMO manufacturing sites, including international travel as needed.

The Opportunity

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.

Primary 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.

Qualifications and Key Success Factors

• Bachelor's degree in engineering, pharmaceutical sciences, chemistry or a related discipline; advanced degree preferred.
• 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.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and sustained focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Additional information

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus.

Compensation & Benefits

• At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.
• This includes 99% of the premium paid for medical, dental and vision plans.
• We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• Thinking about the future?

• We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.
• We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.
• Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.
• We aim high, collaborate hard, and produce results.

Let's achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

Annualized Base Salary $214,000 - $234,000 USD

Diversity, Equity & Inclusion

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