Director – Commercial Manufacturing Operations

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $209k - $229k / year

⏰ Full Time

🔴 Lead

⚙️ Operations

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🧬 Biotechnology

⚕️ Healthcare Insurance

🔬 Science

Biotechnology • Healthcare Insurance • Science

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• 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

• 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

• Health Insurance • Flexible work arrangements • Opportunities for professional development