Biological & Biomedical Sciences (Science & Technology) Our client is dedicated to pioneering advanced treatments and solutions through regenerative medicine. Their GMP-compliant facility in Melbourne's south-east plays a central role in ensuring that their cutting-edge products are delivered with the highest standards in patient safety and quality. As they continue to expand, we are seeking an experienced and strategic Head of Operations to lead their manufacturing activities and contribute to their mission of transformative health innovations. Position Overview The Head of Operations is responsible for overseeing all manufacturing-related activities, ensuring seamless and compliant production aligned with Good Manufacturing Practices (GMP). This role is integral to the smooth operation of the business and requires close collaboration with the Head of Quality to ensure strict adherence to industry standards. Key areas include scheduling, equipment and materials management, supply chain coordination, and implementing operational improvements. Key Responsibilities Operational Leadership : Develop, implement, and maintain procedures for manufacturing activities within a GMP environment, ensuring company and partner products meet regulatory standards. Process Management : Forecast, establish, and maintain operational procedures, work schedules, and equipment layout, with an emphasis on digital platform integration. Facility Compliance : Ensure the facility meets validation requirements as defined by TGA and other regulatory bodies. Performance Monitoring : Set manufacturing KPIs, report on progress, and implement continual improvement initiatives to maximize efficiency and meet financial targets. Downtime Management : Schedule and oversee calibration, maintenance, pest control, and cleaning activities to minimize production interruptions. Team Leadership : Effectively manage support staff, ensuring resource availability aligns with project needs and forecasted demand. Supply Chain Management : Oversee planning, warehousing, and supply chain operations to meet DIFOT, unit cost, and quality standards for both the company and partner products. Cost Optimization : Drive cost reduction initiatives to enhance market competitiveness. Risk Management : Implement risk management protocols that prioritize product quality, patient safety, and business continuity. Key Requirements Lean Manufacturing Mindset : Experience in optimizing processes for efficiency and quality. Cross-functional Leadership : Strong ability to lead and mentor cross-functional teams. GMP Manufacturing Expertise : Extensive experience in GMP environments with a proven track record in facility and process management. Qualifications Educational Background : Postgraduate degree in Science, Engineering, or a similar discipline. Experience Strong knowledge of GMP manufacturing with practical application experience. Extensive experience managing support staff and using plant/process equipment. Proficiency in supply chain, materials management, distribution, and cold chain shipping. Project management skills, ideally using MS Project, in a regulated environment. Proven ability to troubleshoot operational challenges and lead teams. #J-18808-Ljbffr