Director – Commercial Manufacturing Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the operational lead for commercial manufacturing performance at designated CDMO partners, ensuring the dependable execution of production schedules, supply obligations, and operational preparedness.

• Direct a cross-functional Virtual Manufacturing Team, coordinating Manufacturing, MSAT, Quality, Supply Chain, Procurement, Regulatory, and Analytical Development towards a unified operational plan and defined priorities.

• Cultivate comprehensive operational awareness of manufacturing performance, proactively identifying risks related to staffing, equipment, materials, scheduling, and compliance before they affect patients or supply.

• Promote operational excellence by establishing significant performance metrics, tracking trends, and collaborating with CDMO leadership to enhance right-first-time performance, schedule adherence, cycle times, yields, and overall manufacturing reliability.

• Collaborate closely with Quality to ensure that deviations, investigations, CAPAs, change controls, and audit findings are addressed promptly while adhering to the highest standards of GMP compliance.

• Lead the operational response during manufacturing challenges, serving as the primary Praxis representative during batch-at-risk incidents, supply interruptions, or major operational escalations.

• Advocate for a culture of continuous improvement by identifying and executing initiatives that enhance operational performance, lower costs, increase capacity, and bolster long-term CDMO capabilities.

⛳️ Requirements

• Bachelor’s degree in engineering, pharmaceutical sciences, chemistry, or a related field; advanced degree preferred, or equivalent experience.

• Over 15 years of experience in pharmaceutical or biotechnology manufacturing, including substantial leadership roles in commercial GMP operations.

• Proven experience in leading manufacturing operations at a commercial manufacturing facility (Plant Manager, Operations Leader, or similar operational leadership position).

• Extensive experience managing external manufacturing partners (CDMOs) for commercial products.

• Strong understanding of commercial manufacturing operations, GMP regulations, quality systems, deviation management, CAPA processes, and continuous improvement methodologies.

• Proven ability to influence cross-functional teams and external partners without direct reporting authority.

• Exceptional communication skills with the capability to convert operational complexities into clear business decisions for senior leadership.

🏝️ Benefits

• Health Insurance

• Flexible work arrangements

• Opportunities for professional development