Director - Commercial Manufacturing Operations

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, 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.