Head of Process Science & Validation (PSV)
Copenhagen, Danish Capital Region, DK
Head of Process Science & Validation (PSV)
Are you passionate about shaping the future of biologics development at Lundbeck? As our new Head of Process Science & Validation (PSV), you will play a pivotal role in overseeing strategic and operational aspects of process science and validation across multiple sites and geographies. This global position is critical to ensuring alignment with Lundbeck's strategic objectives, regulatory expectations, and biologics development goals.
Your new role
In this exciting leadership role, you will:
- Lead and manage the global Process Science & Validation function within CMC Biologics, ensuring high-quality deliverables within budget and agreed timelines.
- Oversee team leaders of cross-functional teams, ensuring strategic alignment, resource allocation, and task execution.
- Drive initiatives to reduce the Cost of Goods Sold (COGS) and support the development of biologics and bioprocessing business cases.
- Develop and implement innovative processes to enhance efficiency and maintain regulatory compliance.
- Represent the Process Science & Validation function in governance boards and cross-functional teams, providing strategic input on biologics development and production.
- Collaborate with internal and external partners to support process optimization, validation, operational readiness, and drive innovation.
You will report directly to the VP of CMC Biologics and be part of the CMC Biologics leadership team, working closely with site leaders across geographies, including Seattle and Valby. As a member of the CMC Biologics leadership team, you and the other leaders share responsibility for driving the development of the biologics pipeline as well as people development and will coordinate in LT forums on a continuous basis.
Your future team
You will join the CMC Biologics department, a dynamic and innovative team dedicated to advancing biologics development. As a manager-of-managers, you will provide leadership to team leaders overseeing cross-functional teams, fostering a high-performance culture while ensuring alignment with Lundbeck’s strategic goals.
The position is based in Valby, Denmark.
What you bring to the team
We are looking for a candidate who possesses:
- PhD in a relevant scientific field with documented leadership skills and significant expertise in CMC and drug development throughout the biologics value chain.
- 10+ years of experience in process science, validation, and drug development, with a focus on biologics.
- Strong technical and strategic acumen in biologics development, particularly in BDS development, optimization, tech transfer, and validation.
- Proven ability to manage cross-functional teams across geographies and maintain clear oversight of global priorities.
- Expertise in leading change, developing people, and building business processes.
- Demonstrated ability to inspire and motivate teams, fostering a collaborative and high-performing culture.
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 in 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.
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.