Director, Operations

A global CDMO is seeking a Director of Operations to lead operational readiness for a major U.S. growth investment focused on small molecule manufacturing. This individual will play a critical leadership role in bringing a new manufacturing operation online, ensuring readiness across facility design, commissioning, qualification, validation, start-up, and commercial operations.

This is a highly visible position that will partner with executive leadership and cross-functional teams to establish the operating model, build the organization, and ensure a successful transition into routine manufacturing operations.

Key Responsibilities

• Lead operational readiness strategy and execution for a large-scale capital investment project.
• Develop the future manufacturing organization, including workforce planning, organizational structure, training strategy, and operating processes.
• Represent Operations throughout facility and process design to ensure manufacturing requirements are incorporated into project decisions.
• Partner closely with Engineering, Quality, Technical Operations, Automation, EHS, and Project Management teams.
• Drive manufacturing readiness through commissioning, qualification, validation, inspection preparation, and start-up activities.
• Support technology transfer, process implementation, and new product introductions.
• Identify and mitigate operational, technical, and project-related risks.
• Build and develop a high-performing operations team while providing strategic recommendations and readiness updates to senior leadership.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related technical discipline. Advanced degree preferred.
• 10+ years of leadership experience within API manufacturing environments.
• Demonstrated experience leading or supporting manufacturing operations for small molecule, API, chemical process, or highly regulated production environments.
• Experience supporting major capital projects, facility expansions, start-ups, greenfield, or brownfield manufacturing investments.
• Strong understanding of GMP manufacturing, process validation, commissioning, qualification, regulatory inspections, and operational excellence.
• Experience working in complex, containment-intensive manufacturing environments is preferred.
• Proven success leading cross-functional teams and influencing stakeholders across multiple functions.
• Track record of building organizations, developing talent, and implementing scalable operating models.
• Strong communication, strategic planning, and change management capabilities.

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