Director – Commercial Manufacturing Operations

Praxis

Director, Commercial Manufacturing Operations overseeing commercial manufacturing performance for CDMO partners at Praxis Precision Medicines. Ensuring reliable supply, operational excellence, and high-quality product delivery.

Posted 7/9/2026full-timeRemote • 🇺🇸 United StatesLead💰 $209,000 - $229,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing commercial manufacturing operations, ensuring compliance with GMP regulations, and leading cross-functional teams to drive operational excellence and continuous improvement in a CDMO environment.

Highest-signal resume keywords

GMP ComplianceCommercial Manufacturing OperationsCross-Functional Team LeadershipDeviation ManagementContinuous Improvement Methodologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmaceutical ManufacturingBiotechnology ManufacturingPerformance Metrics DevelopmentOperational ReadinessSupply Chain ManagementQuality SystemsCAPA ProcessesRisk IdentificationManufacturing Performance MonitoringSchedule Adherence

Soft Skills

Excellent CommunicationInfluencing Without AuthorityTeam CollaborationProblem SolvingLeadership

Industry Keywords

CDMOOperational ExcellenceBatch-at-Risk EventsManufacturing IssuesPharmaceutical SciencesEngineeringChemistry

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health Insurance
Flexible work arrangements
Opportunities for professional development