Director, Operations

About This Role

Directing the Baltimore site operations within a highly regulated in vitro diagnostic (IVD) development and manufacturing environment is the core responsibility of this senior leadership role. The Director of Operations provides strategic and operational leadership across various functions to ensure the delivery of high-quality products and services. This position reports to the Vice President, Head of Science, Oncology, and is a key member of the site leadership team.

Responsibilities

• Provide leadership and direction to a multi-functional operations organization including manufacturing, supply chain, engineering, facilities, business operations, and environmental health & safety
• Establish and maintain a high-performance culture focused on accountability, employee development, operational excellence, and continuous improvement
• Lead manufacturing operations within a highly regulated environment, ensuring compliance with applicable FDA, ISO 13485, cGMP, and other global regulatory requirements
• Drive operational performance through defined metrics and KPIs related to safety, quality, customer service, inventory management, productivity, and cost
• Develop and execute strategic operational plans that support business growth, manufacturing scale-up, capacity planning, and long-term operational readiness
• Champion Lean Manufacturing, Six Sigma, and continuous improvement initiatives to enhance efficiency, reduce waste, improve quality, and optimize resource utilization
• Build and develop leadership capability across the organization through coaching, talent development, succession planning, and organizational effectiveness initiatives
• Lead operational readiness for regulatory inspections, customer audits, and certification activities while ensuring ongoing compliance with quality management systems
• Partner with Product Development and Engineering teams to ensure successful technology transfer, design transfer, new product introduction, and commercialization activities
• Own site-level operational performance, budget management, capital planning, and workforce strategy

Requirements

• Bachelor's degree in Engineering, Operations Management, Supply Chain, Life Sciences, or related discipline
• 10 or more years of progressive leadership experience in manufacturing, operations, supply chain, or engineering within a highly regulated industry such as IVD, medical devices, diagnostics, biotechnology, pharmaceutical, or life sciences
• 5 or more years of experience in leading managers and multi-functional teams across manufacturing and operational disciplines
• 5 or more years of experience supporting regulatory inspections, customer audits, and compliance activities
• 5 or more years of experience with new product introduction (NPI), technology transfer, process validation, and commercial product manufacturing