Senior Manager, Team Lead Upstream Process Science and Validation

Lundbeck; København; Presencial; DKK 786.000 - 1.081.000; Jornada completa

Descripción de la vacante

Lundbeck seeks a Senior Manager and Team Lead for Upstream PSV to guide a team of experts across mammalian upstream processes, technology transfer and validation. You will set strategy, allocate resources, and ensure high-quality delivery for GMP and regulatory readiness.

You will report to the Senior Director for PSV in CMC Biologics and work with external CMOs, Process Development and Quality. This role is based in Valby, Denmark, with a focus on scientific leadership and continuous

Formación

• Master's or PhD in a relevant field with substantial industrial CMC experience.
• Deep understanding of mammalian upstream processes, tech transfer and process validation.
• Proven leadership, project management and cross-functional collaboration.

Responsabilidades

• Lead and develop the Upstream PSV team, including resource planning and performance development.
• Provide scientific direction for CMO-executed upstream activities and PPQ readiness.
• Guide scopes, timelines, and technical strategies across projects.
• Ensure cross-functional collaboration with Process Development, Downstream PSV, QRM and Regulatory CMC.
• Contribute to regulatory submissions and health authority interactions.
• Foster continuous improvement of PSV standards and ways of working.

Conocimientos

Leadership

Upstream process knowledge

Validation expertise

CMC Biologics experience

Stakeholder management

English communication

Educación

Master's or PhD in biotechnology/biochemistry/pharma sciences/chemical engineering

Herramientas

LIMS

Regulatory submission systems

Descripción del empleo

Senior Manager, Team Lead Upstream Process Science & 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.

Your new role

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.

Your responsibilities will include:

• 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.

Your future team

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 supports an agile working environment that helps balance collaboration with individual flexibility.

The position is based in Valby, Denmark.

What you bring to the team

We are looking for an experienced biopharmaceutical leader who combines deep upstream process understanding with strong people leadership and the ability to create results through others.

You bring:

• A Master's degree or PhD in biotechnology, biochemistry, pharmaceutical sciences, chemical engineering or another relevant field, combined with significant industrial experience in biopharmaceutical CMC; 8+ years of relevant experience would typically provide the breadth needed for the role.


• Strong scientific and technical understanding of mammalian upstream processes, including cell culture, bioreactor operation, process parameters, raw materials, media and feed strategies, scale-up, process control strategies and process robustness.


• Documented people leadership experience, along with experience in process characterization, risk assessment, process validation and PPQ, technology transfer, regulatory submissions and health authority interactions.


• Experience working with CMOs or other external manufacturing partners, together with solid stakeholder management and communication skills in English.

You are motivated by developing people and creating results through a highly specialized team. You combine scientific depth with clear leadership, can translate complex CMC challenges into practical strategies and priorities, and are comfortable working across functions and external partners. You are curious about new digital and AI-enabled ways of working and use them pragmatically where they can strengthen analysis, knowledge sharing or efficiency. You build trust through open communication and collaboration while maintaining clear accountability for delivery.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion .

Annual base salary range: 786 000 - 1 081 300 DKK gross

At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.

Learn more about us at www.lundbeck.com , LinkedIn or Instagram (@h_lundbeck).

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck.

We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.