Director, Operations

About Us:

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary:

Under the direct supervision of the Vice President of Technical Operations (US), the incumbent will lead the full operational activities of our Tamarac sterile manufacturing and packaging site. This role is crucial in ensuring safe work practices, manufacturing efficiency, regulatory compliance, and operational excellence, with a strong focus on aseptic processing and sterile products. The incumbent will drive day-to-day performance, develop systems to evaluate area performance, and contribute to continuous improvements in process reliability, quality, performance, and cost efficiencies. Additionally, this role will ensure alignment with strategic corporate objectives, fostering a culture of continuous improvement and high performance.

Job Responsibilities:

• Manages day to day operations by establishing site priorities and directing site activities to ensure quality products are formulated, developed, produced, and delivered to Aveva’s customers, in support of company goals and objectives. As the site expands, managing 2-3 Direct reports.
• Align site operations strategy with broader business objectives, including demand forecasting, capacity expansion, and new product introductions.
• Lead, mentor, and develop a high-performing technical operations team, driving a culture of ownership, accountability, collaboration, and innovation.
• Foster a work environment where individuals and teams consistently take ownership of outcomes, enhancing trust, performance, and organizational success
• Lead end-to-end production of sterile injectable products, including Blow-Fill-Seal (BFS), vials, syringes, cartridges, and other delivery formats.

• Optimize key manufacturing operations (compounding, aseptic filling, inspection, packaging) to improve efficiency, reduce cycle times, enhance yields, and minimize waste.
• Prepares and administers department budget to achieve the site plan, maintaining cost consciousness and stressing operational efficiencies throughout.
• Ensure strict compliance with cGMPs, FDA regulations, and other applicable global standards for aseptic manufacturing
• Strengthen contamination control strategies, including gowning practices, cleanroom behaviors, and environmental monitoring systems; plays an active role on quality management teams within the organization.
• Ensures compliance with all safety rules and regulations and creates, monitors, and maintains a safe work environment.
• Develops, nurtures, and trains staff to further departmental and organizational goals.
• Provides project management support for new and existing internal products as well as client’s products.
• Ensures project deadlines and performance standards are established and met.
• Provides technical support and problem solving for new products under development as well as existing commercial products.
• Develops organizational objectives to meet organization’s needs.
• Ensures that accurate and up to date SOP’s are in place and that all departments are in compliance with current procedures and practices.
• Sponsors and facilitates the use of systems and metrics to guide the initiation and execution of safety, quality, productivity and continuous improvement initiatives in support of the Operations Strategic Plan and Production Plan.
• Establish and monitor operational KPIs including Batch Yield and Scrap Rates, Throughput and Cycle Times, First Pass Quality and Deviation Metrics, Machine Downtime and OEE, On-Time Delivery and Supply Plan Adherence<