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. #J-18808-Ljbffr