Technical Lead

작업 내용

Make your mark for patientsTo strengthen our Pharma Science team,we are looking for a high caliber, self-motivated,Technical Lead based in Braine l’Alleud, BelgiumAt UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.You like to work in an environmentwhere you will:

• Define, implement and manage the Product CMC development and lifecycle strategy for a given asset, from early development to end of commercialization, encompassing the geographical specificities and regulations.
• Act as the S&TS representative in the PV Missions for all technical aspects to ensure mutual understanding and alignment i.e. translate business requirements into technical solutions & translate technical aspects into meaningful business & patient impacts.
• Contribute to the Product/Asset 10 Year Plan and yearly budget by defining & consolidating related CMC activities, resources and budget. (deliverable = financial 10YP)
• Bring the key CMC inputs into the TPVP and drive the translation into the QTPP
• Based on TPVP/QTPP, define the development scenarios (eg: formulations, device, pack,...) and select the optimal strategy to move products seamlessly from a development to a commercial set up (deliverable = CMC plan).
• Lead the CMC Product risk analysis and ensure appropriate mitigation plans are implemented and properly reported to the S&TS Risk Committee
• Lead the cross-functional Technical Team
• Ensure appropriate communication from/to key stakeholders (S&TS functions & PV missions), governance committees, technical team (TST), i.e. progress update, issue escalation, key decisions, major changes, resource constraints,…
• Define and communicate key CMC milestones and yearly CMC objectives within S&TS, PV Missions and TST.
• Track & report the ongoing performance of the CMC activities (CMC milestones & budget).
• Support the S&TS Asset Long Range Plan (LRP) definition and implementation through the CMC Program management.
• Drive the CMC Product Program and prioritization to ensure development strategy & commercial manufacturing/supply/COGs/patient solution improvement strategy are properly executed
• Ensure manufacturing and release readiness for clinical trials & launch in line with submission
• Contribute to the definition of the overall submission plan (worldwide)
• Contribute to the clinical & launch team for CMC aspects as appropriate

Interested? For this position you’ll need the following education, experience andskills:

• You have a pharma business understanding in a global world and the CMC regulations applicable during development, commercialization and decline of product life cycle including geographical specificities.
• You have an established and recognized expertise in Technical, RA & QA matters including previous successful leadership positions within S&TS or equivalent.
• You have a solid understanding of the end-to-end CMC and life cycle management process (and associated disciplines), its major process steps and particularities of each project step, ideally for both Bio and small molecules.
• You have a strong expertise in Project management with Transversal team in a multicultural environment.
• You are skilled in GMP quality and regulatory requirements
• You are a skilled reviewer of technical documentation

Why you should applyWe can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.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.