External Manufacturing Operations Lead – Drug substance

Job title:

External Manufacturing Operations Lead – Drug substance

Company:

UCB

Job description

Make your mark for patientsWe are looking for External Manufacturing Operations Lead (EMOL) to join us in our External Manufacturing Drug Substance Team (based in Belgium – Braine l’Alleud or Switzerland – Bulle).About the roleAs a UCB External Manufacturing Operations Lead, you are accountable for the ultimate performance of the CDMO, coordinating the necessary internal resources and setting the priorities to meet the needs of UCBs downstream activities.You will have a deep understanding of all manufacturing and technical aspects relating to the sites within your portfolio, but will also have an appreciation of the business drivers of the sites. By maintaining strong links with the CDMO leadership teams you will ensure the site delivers on the expectations, and that improvements, where needed, are made in line with agreed milestones.The role includes the close interaction with other UCB functions as the CDMO / Manufacturing Operations SME on key projects and strategic initiatives delivered across the external manufacturing network.What you’ll do

• Ensure performance of a defined portfolio of CDMO’s /strategic vendors. This is achieved by ensuring reliability to deliver the manufacturing plans, robustness of the processes, responsiveness to issues and building strong relationships with Vendors and internal stakeholders.
• Lead the CMO Vendor Teams coordinating cross-functional and inter-company activities including assessment of capability/development and resourcing needs.
• Lead or participate in transversal initiative/project to develop the operational excellence culture into UCB External Manufacturing.
• Maintain the appropriate governance structures with their portfolio of CDMOs and lead the periodic meetings between CMOs and UCB multifunctional teams.
• Perform the regular operational performance evaluation and management processes of the CDMO’s in his/her portfolio.
• Provide the technical expertise to support UCB’s CDMO in order to ensure effective processes, optimize capacity utilization and deliver according to state-of-the-art quality standard.
• Perform 1st line troubleshooting at CDMO in scope and lead investigations and CAPA implementation in case of complex, business relevant technical and supply issues.
• Identify continuous improvement and performance improvement opportunities at the CDMO, develop the long-range plans and budgets associated.
• Ensure compliance to regulatory standards and industry regulations, implementing best practices, and fostering a strong culture of compliance to always ensure inspection readiness at CDMOs within his/her portfolio.
• Define and manage risk at the CMOs, including capacity availability and potential supply chain disruptions.
• Monitor underlying CDMO capacities and implement Products long range plans in coordination with relevant UCB functions.
• The role may also include the line management of EMOLs.

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

• Master’s degree with at least 5 to 10 years’ experience in a similar role OR in any relevant Operations Management role within a GMP environment.
• Ability to lead multi-functional teams, influence others, hold teams accountable, results orientated, effective at networking.
• Must be able to manage external business partners and relationships including negotiation skills and leadership presence as representative of UCB in discussion with senior management members of CMO’s.
• Ability to lead a Team.
• Strong technical knowledges in manufacturing of Biotech products.
• Fluent in English (Written & Spoken).

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 around 8,500 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 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.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/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.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.

Expected salary

Location

Braine-l’Alleud, Brabant Wallon

Job date

Sat, 07 Dec 2024 05:25:46 GMT

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