Drug Product Project Lead

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Make your mark for patientsWe are looking for a Drug Product Project Lead who is to join us in our Product Development team, based in Braine-l’Alleud, BelgiumAbout The RoleThe Drug Product (DP) Project Lead is responsible for:

• one or more development project depending on project complexity and phase of development (from preclinical to commercial launch and lifecycle management).
• leading a sub-team of empowered functional subject matter experts for assigned project(s) representing all aspects of Drug Product in the TST and ensuring appropriate 2-way communication between TST and function.
• defining and implementing an integrated Drug Product strategy in collaboration with SMEs, functional line management and in alignment with the overall CMC strategy for assigned project(s).

Who You’ll Work With

• Flore Depreter as your manager as well as many other stakeholders in your projects.

What You’ll Do

• Lead a sub-team of empowered technical functional subject matter experts and scientists for assigned project(s) to:
• Facilitate detailedtechnical functional sub-team
• Co-develop integrated functional project strategies and plans for DP designated projects from early development to launch by identifying and consolidating project related work packages(internal and external) that are delivered through the different SME’s.
• Hold SME’s accountable for delivering work packages as per integratedfunctional project plans to quality, quantity, timelines and budget.
• Ensure appropriate documentation is available and retrievable.
• Integrate all aspects of DP toensure that SME’s work packages (internal and external) are initiated, executed and delivered to meet project timelines, milestones and deliverables .
• Identify, communicate and manage risks associated with assigned project(s) and to develop appropriate mitigations.
• Functional DP representativein the TST as a Core TST member in early phase and extended TST member in late stage when CMC lead is identified .
• Represent technical DP department during internal and external meetings and liaise with key stakeholders.
• Closely collaborate with other project leaders, SME’s within Pharma Sciences (PS), UCB community across functions and organizations to ensure delivery of cross-functional activities to quality and time.
• In collaboration with SME’s and PS-Operation evaluate and recommend outsourcing/insourcing strategy for project in line with departmental and PS Strategy.
• Provideaccurate and consolidated functional resource and budget requirements for assigned project(s) to TL/TST ensuring prior alignment with line manager.
• Proactively plan, track, drive all project related activities and expenditures in their area of accountability ensuring full adherence to costs, quality, quantity, and timelines ensuring any deviations are appropriately escalated.
• Responsiblefor risk management for assigned project(s) within the function ensuring all major risks are identified, reported, escalated, and adequately mitigated.
• Be an ambassadorfor the implementation and continuous improvement of the operating model in the function .
• Ensurecompliance with PS and department governance processes .
• Ensureproactive and timely stakeholders management .
• Provide scientific leadership and project management for one or more assigned project(s) based on phase of development and complexity.
• Contribute to the coordination and review of relevant source documentation from technical function as required for filing/submission and actively support the registration processes.
• Contribute to setting departmental goals & priorities.
• Act as key enabler for implementation of the operating model for assigned project(s).

Interested? For this role we’re looking for the following education, experience andskills

• Phd or Master’s degree preferred.
• At least 8 years of relevant experience in CMC Development for Pharmaceuticals.
• Excellent knowledge and experience in Drug Product Development.
• Strong knowledge of the regulatory & quality requirements related to technical functional area for the different clinical phases.
• Strong Project Management skills to enable the coordination and the prioritization of all activities (internal and external) to meet project timelines and deliverables, to provide resource and budget requirements to TL/TST and to plan, track, drive all project related activities and expenditures.
• Skilled in Risk Management processes with the ability to challenge status quo and a mindset that encourages taking informed, balanced risks making smart decisions and fostering risk-baseddevelopment approaches.
• Very good command in English.

Soft Skills

• Drive decision-making process in a multidisciplinary matrix organization based on complex and/or incomplete information.
• Process, understand and challenge complex information and plans to deliver optimal solutions and strategies.
• Simplify complex situations. Can deal with unclear situations and take risks in uncertain situations through suitable evaluation and mitigation plans.
• Fully at ease working in a matrix environment with indirect leadership responsibilities to lead a technical cross-functional sub-team of experts.
• Excellent communication skills with the ability to convey complex information in a concise manner to ensure appropriate 2-waycommunication between TST and function and to interact with management across a matrix organization.
• Team playerwith an open and collaborative mindset who can be relied upon to coach/mentor subject matter experts if needed and help team solve problems leveraging diversity.
• Excellent technical written and oral communication skills and skilled at reviewing technical documents.

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 UsUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work for 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 equitable 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.Learn more about sustainability at UCB and how it is integrated into our business approach.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.