QC Professional, Biologics

QC Professional, Biologics

Join our QC Biologics team and take part in the journey of restoring brain health.

Want to contribute to ensure quality in our expanding portfolio of Biologics commercial products? We are expanding our team and are now looking for a QC Professional.

Your new role

In this role, you will play a key part in establishing our in-house GMP QC laboratory for Biologics. You will lead critical laboratory activities—including equipment qualification, analytical method transfer, and validation.

You may also take on vendor management responsibilities such as change control, deviation handling, and oversight of external release and stability testing at multiple Contract Manufacturing Organizations (CMOs) and Contract Test Laboratories (CTLs).

A significant part of the role involves supporting the transfer of Biologics development candidates to commercial manufacturing and guiding analytical activities related to this.

Some international travel is expected to maintain close partnerships with our CMOs, CTLs, and our site in Seattle, WA.

Your future team

You will become part of a motivated and collaborative QC Biologics team that supports Lundbeck’s rapidly growing Biologics pipeline. We value openness, collaboration and building processes scalable with our ambitions for the future.

Our team works closely with colleagues across development QC/QA, commercial QA, regulatory affairs, production, supply chain, and with our global vendors to ensure analytical support throughout the product lifecycle.

You will have the opportunity to shape your role based on your interests and expertise, and contribute directly to strengthening our commercial QC Biologics capabilities.

The position is based in Valby, Denmark.

What you bring to the team

Our preferred candidate has the following personal and professional qualifications:

• MSc or PhD in relevant scientific field with 5+ years of experience.
• Working knowledge of cGMP, ICH, pharmacopoeias, and other guidelines.
• Experience with release and stability testing of biologics, including potency assays and CE.
• Good English written and oral communication skills.
• Experience with direct support of laboratory activities including validations or method transfers.

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 Ane Rømer Troels-Smith, Director, CPQC Biologics, ANRS@Lundbeck.com. 

Applications must be received by January 5, 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.