Director OF Operations

Director, Operations provides strategic and operational leadership by setting the manufacturing vision across departments and overseeing the development, implementation, and continuous improvement of pharmaceutical manufacturing processes. Lead all site operations (manufacturing and maintenance), ensuring product quality, safety, and efficacy in full compliance with GMPs, regulatory requirements, SOPs, and product specifications. Build, develop, and sustain high-performing teams across manufacturing, maintenance, and operational excellence. Ensure execution of capital projects, operating budgets, and manufacturing schedules to meet performance targets. Resolve complex operational issues using data-driven analysis and sound judgment. Requirements BS in Engineering, Life Sciences, or related field; MS or MBA preferred. Minimum 8-10 years of progressive manufacturing experience in FDA-regulated pharmaceutical operations; sterile injectable manufacturing experience preferred. Working knowledge of FDA regulations and cGMP requirements for sterile injectable products. Demonstrated experience hosting FDA inspections and managing audit remediation plans. Proficiency in aseptic process simulation/media fills, and sterility assurance principles. Exceptional ability to communicate complex information clearly and effectively to diverse audiences, including executive leadership. Core Competencies Demonstrates strategic and operational leadership in pharmaceutical manufacturing, with a focus on compliance with FDA regulations and cGMP requirements. Proven ability to build high-performing teams and manage complex operational challenges through data-driven analysis. #J-18808-Ljbffr