Drug Product Industrial Lead
Il y a 2 semaines
Brainel'Alleud, Wallonia, Belgique
UCB
Temps plein
Gratuit avec email ou Google
Enregistrez cette offre et organisez votre recherche
Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.
Gratuit avec email ou Google
En continuant, vous acceptez nos Conditions d’utilisation & Politique de confidentialité.
Make your mark for patients
We are looking for a Drug Product Industrial Lead to join our Industrialization & Network Planning team in Braine-l'Alleud, Belgium, who is strategic, experienced in drug product development and manufacturing, and skilled in project management and stakeholder management.
About the Role
In this global role, the Industrial Lead Drug Product will bring a strategic vision and leadership in the industrialization of our late-stage development and commercial products (NBE and NCE). You will develop cutting-edge industrialization strategies, manage a portfolio of strategic manufacturing projects/programs. You will act as the Drug Product subject matter expert within UCB’s Community, support Drug Product 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 Drug Product 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 across Patient Supply, Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Technical Solution Teams, Procurement, Finance, and internal and external manufacturing partners. What You’ll Do
• Develop Manufacturing Industrial Strategic Supply Plans for Drug 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 Drug Product 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 Drug Product industrial interests in TSTs and relevant governance bodies.
• Lead cross-functional teams and drive clear recommendations, decisions, and escalation on strategic Drug Product 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 pharma or biological Drug Product manufacturing, development, and industrialization, with familiarity across Drug Product processes and direct commercial-manufacturing experience, with familiarity with state-of-the-art drug product manufacturing processes.
• Strong project or program management experience and leading multidisciplinary project teams, transversal activities.
• 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. Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. 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, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application. 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. Requisition ID: 94079 Recruiter: Gavin Savage Hiring Manager: Sandrine Vantomme Talent Partner: Fiona Ross Job Level: MM I Please consult HRAnswers for more information on job levels.
About the Role
In this global role, the Industrial Lead Drug Product will bring a strategic vision and leadership in the industrialization of our late-stage development and commercial products (NBE and NCE). You will develop cutting-edge industrialization strategies, manage a portfolio of strategic manufacturing projects/programs. You will act as the Drug Product subject matter expert within UCB’s Community, support Drug Product 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 Drug Product 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 across Patient Supply, Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Technical Solution Teams, Procurement, Finance, and internal and external manufacturing partners. What You’ll Do
• Develop Manufacturing Industrial Strategic Supply Plans for Drug 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 Drug Product 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 Drug Product industrial interests in TSTs and relevant governance bodies.
• Lead cross-functional teams and drive clear recommendations, decisions, and escalation on strategic Drug Product 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 pharma or biological Drug Product manufacturing, development, and industrialization, with familiarity across Drug Product processes and direct commercial-manufacturing experience, with familiarity with state-of-the-art drug product manufacturing processes.
• Strong project or program management experience and leading multidisciplinary project teams, transversal activities.
• 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. Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. 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, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application. 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. Requisition ID: 94079 Recruiter: Gavin Savage Hiring Manager: Sandrine Vantomme Talent Partner: Fiona Ross Job Level: MM I Please consult HRAnswers for more information on job levels.