Device Assembly Packaging Industrialization Lead

Job description

Make your mark for patients We are looking for a Device Assembly & Packaging Industrialization Lead who is strategic, experienced in combination product development and manufacturing to join our Industrialization & Network Planning team in Braine-l'Alleud, Belgium . About the Role In this global role, the Device Assembly & Packaging Industrialization Lead, will bring a strategic vision and leadership in the industrialization of our late-stage development and commercial products. You will develop cutting-edge industrialization strategies, manage a portfolio of strategic manufacturing projects/programs for device assembly, secondary packaging, and combination products throughout the product lifecycle. You will act as the combination product and/or packaging subject matter expert within UCB’s Community, support Device (combination product) and packaging development and provide manufacturing and regulatory submission leadership. You will lead transversal activities related to launch readiness and lifecycle management. You will act as the Device (combination product) and packaging expert in TSTs, lead functional sub-teams of subject matter experts, and bring Drug Product topics to the appropriate functional and governance bodies. Who You’ll Work With You will collaborate with colleagues across Patient Supply, Device and Packaging Development, Drug Product, internal and external manufacturing, MSAT, Quality, Regulatory Affairs, Procurement, finance and other technical teams. What You’ll Do Develop global industrialization and manufacturing strategies for device assembly, secondary packaging, and combination products throughout their lifecycle, aligned with the broader supply-network strategy. Build and oversee the strategic industrial project portfolio covering launches, lifecycle management, technology transfers, validations, process optimization, and network changes. Establish long-term capacity, capability, and investment plans across manufacturing technologies and assets. Act as the device assembly and/or packaging industrial SME, aligning product-development strategies with manufacturing technologies, capabilities, capacities, and sustainability objectives. Ensure launch readiness and effective lifecycle management for late-stage development and commercial products. Develop industrial scenarios and business cases, including Cost of Goods assumptions, investment needs, risks, and mitigation plans. Evaluate the technical, regulatory, financial, and environmental feasibility of line extensions, manufacturing changes, multisourcing, and other lifecycle options. Provide manufacturing leadership for validation strategies and CMC regulatory activities. Centralize commercial manufacturing knowledge and represent Device assembly and/or packaging industrial interests in TSTs and relevant governance bodies. Lead cross-functional teams and drive clear recommendations, decisions, and escalation on strategic Device assembly and/or packaging topics. Interested? For this role we’re looking for: Master degree in Pharmaceutical Sciences, Engineering, Biotechnology, Life Sciences, or a related discipline. Minimum 7 years’ experience in the pharmaceutical or biotechnology industry within development, industrialization and/or manufacturing. Experience in device assembly and packaging industrialization, development, and industrialization, with familiarity across device assembly and packaging processes and direct commercial-manufacturing experience, with familiarity with state-of-the-art combination product and packaging manufacturing processes. Strong project or program management experience and leading multidisciplinary project teams, transversal activities. Good understanding of combination products, contract manufacturing, cGMP, medical-device quality systems, and regulatory approval processes. Expertise in the registration, and approval processes in the EU, US, China, and Japan; skilled in cGMP quality and regulatory requirements and in writing or reviewing technical, cGMP, and regulatory documentation. Knowledge of financial and budgeting processes, with focus on Cost of Goods and investment decisions; Ability to manage complex projects, balancing multiple priorities, , influencing stakeholders and driving results. Excellent communication, influencing, problem-solving, and stakeholder-management skills, with fluency in written and spoken English. Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! About us UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science. Why work with us? At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.