Senior Manager, Team Lead Upstream Process Science and Validation

Do you want to lead a highly skilled upstream team and help shape how Process Science & Validation (PSV) support Lundbeck’s biologics portfolio? Join us as Senior Manager and combine people leadership with scientific direction in a CMO‑based manufacturing model, helping ensure robust upstream processes from technology transfer through process characterization and validation, PPQ and commercial readiness.

As Senior Manager and Team Lead for Upstream Process Science & Validation, you will lead and develop a team of Upstream Subject Matter Experts within PSV in CMC Biologics. Lundbeck's biologics manufacturing is outsourced to external CMOs.

You will set direction, prioritize resources and ensure high‑quality delivery across portfolio projects in close collaboration with Downstream PSV, Process Development, CMC Project Managers, Quality, Regulatory CMC, Analytical Development, and External Manufacturing.

You will guide and challenge upstream strategies, support technical decision‑making and ensure robust CMC input to regulatory submissions and health authority interactions. As part of the PSV management team, you will also contribute to strengthening capabilities and ways of working across PSV.

• Lead, coach and develop the Upstream Process Science & Validation team, including resource planning, hiring, onboarding, performance management, and professional development.
• Provide scientific direction and technical oversight for CMO‑executed upstream activities, including technology transfer, engineering and GMP manufacturing support, process characterization, risk assessments, process validation, PPQ readiness, troubleshooting and transfer to commercial.
• Support the team in defining scopes, timelines, deliverables, technical strategies and risk‑based approaches across projects.
• Ensure effective cross‑functional and CMO collaboration, clear technical decision‑making, timely issue resolution and high‑quality upstream contributions to Module 3 submissions, health authority questions and post‑approval changes.
• Strengthen collaboration across CMC functions and external partners, and contribute to continuous improvement of PSV standards, templates and ways of working.

You will join CMC Biologics, an organization of 115+ skilled colleagues located in Copenhagen and at our Center of Excellence in Seattle, US.

You will report to the Senior Director for PSV in CMC Biologics. You will lead a team of six upstream subject matter experts who support mammalian upstream process activities across Lundbeck’s portfolio from first GMP batch to PPQ and commercial handover, including process characterization, validation, technology transfer, troubleshooting, manufacturing support, regulatory submissions and health authority interactions.

Collaboration is key to our success. The team works closely with colleagues across Process Development, Downstream Process Science & Validation, Analytical Development, Quality, Regulatory CMC, external manufacturing and CMC project management. We want a team where people share knowledge, stay curious, challenge constructively and support each other in achieving ambitious goals.

As Team Lead, you will create clarity, develop people and capabilities, and foster a culture of scientific rigor, accountability, collaboration and continuous improvement. You will have the opportunity to shape the Upstream Process Science & Validation team and influence how we work across CMC Biologics.

You will be part of an innovative, cross‑disciplinary and cross‑cultural environment with room to bring forward ideas and develop both people and ways of working. Where possible, Lundbeck…