QC Professional, Biologics

Requistion ID:  5271
Location: 

Copenhagen, Danish Capital Region, DK

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 – why is this a great opportunity?

We are seeking a highly motivated individual to join our commercial Quality Control team.  This position will be responsible for vendor management including change control, deviation handling and release and stability testing at multiple external Contract Manufacturing Organizations (CMOs) and Contract Test Laboratories (CTLs).

The key responsibilities also include providing QC support to transfer of Biologics development candidates into commercial manufacturing and lead a wide variety of analytical activities at Lundbeck’s CMOs/CTLs. Direct support to laboratory activities such as equipment qualification, method transfer, and stability analyses can also be part of the role.

Some international travel will be required to establish good relationships with our CMOs and CTLs and our site in Seattle, WA.

 

Your future team

We offer the opportunity to be part of an ambitious and motivated team, where we focus on creating optimal procedures scalable for the future.

Our team collaborates closely with development QC/QA, commercial QA, regulatory affairs, production, supply chain, CMOs and CTLs and you will have a say in defining your own role depending on interests and qualifications.

Lundbeck is built on our great people and culture offering you a place to grow and thrive – personally and professionally. We embrace uniqueness of individuals, knowing we are stronger with every brain in the game. In Lundbeck, our commitment is embedded in our Danish heritage, our solid foundation ownership, and our culture of innovation. Together, we are creating a brighter future for people living with brain diseases. That is our promise to each other and to the world.

 

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 pharmaceutical science, engineering, chemistry, biology, or other related field with at least 2 years of relevant work experience.

  • Working knowledge of cGMP, ICH, pharmacopoeias, and other guidelines

  • Good understanding of release and stability analyses of biologics, including cell-based assay testing, cell culture, and cell banking

  • Good English written and oral communication skills

  • Experience with direct support of laboratory activities

  • Familiar with SAP and LabWare LIMS

 

Our promise to you  

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@h_lundbeck).

 

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. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Ane Rømer Troels-Smith, Senior Manager, 0045 30832493. Applications must be received by 15-May-2024.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and 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.

#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

 

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.
 
As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.
 
Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.