Director, 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.

• 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.

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.