Senior Program Director in CMC Biologics

Are you ready to make a significant impact on Lundbeck's strategic objectives? As our new Senior Program Director in CMC Biologics, you will play a pivotal role in overseeing and coordinating all CMC activities for a high-priority late-stage biologics project. This global role ensures accelerated regulatory approval, commercialization readiness, and future commercial manufacturing, contributing directly to Lundbeck’s mission of improving brain health.

Your new role

In this exciting global role, you will:

• Lead and coordinate all CMC activities for a high-priority late-stage biologics project, ensuring alignment with regulatory requirements and commercialization pathways.
• Represent the PDS CMC function on the Global Project Team (GPT) and internal Lundbeck governance boards.
• Oversee timelines, deliverables, milestones, and budgets for BLA submission, manufacturing tech transfer, and commercialization readiness.
• Collaborate cross-functionally across Lundbeck teams and external partners, driving strategic initiatives that support accelerated timelines for regulatory approval, BLA filing, and launch readiness.
• Manage external suppliers and advisors, building partnerships to ensure operational readiness and driving product innovation initiatives.

You will report directly to the VP of CMC Biologics and work closely with other leaders within the CMCB organization, the Global Project Lead, and ensuring effective cross-functional coordination with teams such as Commercial Product Quality, Supply Chain Management, Project and Portfolio Management, and CMC Regulatory Affairs.

Your future team

You will join the CMC Biologics department, a dynamic and innovative team dedicated to advancing biologics development. While this position does not include direct line management, you will provide substantial informal leadership to 4 CMC teams and collaborate across global teams and external partners. Together, we work towards achieving regulatory approval and commercialization readiness for a high-priority project.

The position is based in Valby, Denmark.

What you bring to the team

We are looking for a candidate who possesses:

• Master’s degree in a scientifically relevant field
• 10+ years in CMC-related roles, including late-stage biologics development, regulatory submissions, and commercialization activities.
• Documented experience with commercialization and launch of biologics.
• Proven expertise in BLA writing and approval, CMC processes, and commercialization strategies.
• Strong leadership and organizational skills, with the ability to manage complex projects and cross-functional teams.
• Exceptional communication skills for effective collaboration with internal and external stakeholders.

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.

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions, please contact Torben Frandsen, VP of CMC Biologics at topf@lundbeck.com.

Applications must be received by October 17th, 2025.

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.