Pilot Plant Manufacturing, Team Head

Summary The Pilot Plant Manufacturing Team Head is responsible for establishing and managing the Production unit and ensuring the manufacturing program is achieved efficiently within the framework of regulatory compliance and operating within high standards of GMP, HSE, environmental protection, and good working practices, as well as a high level of flexibility needed by the Pilot Plant nature. Identify and implement the necessary programs and actions to ensure sustainable, reliable execution of manufacturing operations at the RLT Pilot Plant. About The Role Key responsibilities: Responsible for establishing and maintaining a Production unit and team in full cGMP, HSE, and radioprotection compliance. Establish, optimize, and maintain workflows, methods, procedures, and guidelines for manufacturing. Ensure and maintain qualified status of production equipment and methods for intended use in Production lines. Ensure adequate management of Production-related validations, transfers, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), and Change Control systems. Procure site validation and qualification support, and support site launches of manufacturing products. Prepare and participate in health authorities’ inspections and internal audits in his/her area. Ensure that Production personnel is duly qualified, and manufacturing is properly conducted and documented for all performed activities. Evaluate and approve Production records as required. Manage the staff objectives, performance, and development. Ensure team members are empowered to develop in the plant and company organization through an open mindset without losing focus on Pilot Plant strategic objectives. Support the Director pilot plant for the Production area budget planning, execution, and adherence. Responsible for ensuring that production planning and raw material planning are established and executed as needed to follow manufacturing demand. Guarantee that warehouse management, waste management, as well as finished product shipment management are executed timely, safely, and reliably ensuring best Pilot Plant efficiency. Ensure analysis of trends in deviations and other events are performed and facilitate resolution defining action plans. Follow up on actions to ensure timely execution. Ensure needed flexibility is guaranteed by the production team and manufacturing procedures and routines. Help promote an unbossed culture supporting ownership, innovation, speak-up, and accountability. Essential Requirements PhD or MSc in Pharmacy, Biotechnology, Engineering (industrial fields) or Chemistry. Fluent in Italian. Good knowledge of English (C1). English: fluent (oral and written). At least 7 years of experience in the pharmaceutical industry with direct experience with sterile manufacturing, or similar, 2 years of leadership experience. Related experience should be in GMP-regulated industries in Manufacturing. Proven ability to plan and manage operational processes for maximum efficiency and productivity. Must have an understanding of pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing and validation requirements and activities. Radiation safety education. Strong affinity with and awareness of quality issues. Strong leadership skills (communication, team-working with other departments, drive to enable problem-solving). Exploitation of new technology and techniques to eliminate non-value adding activities and improve productivity/performance through new processes. Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us You will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. J-18808-Ljbffr

Location: ivrea, IT

Posted Date: 2/4/2025