Sr. Scientist / Sr. Specialist for Biologics Production, CMC Biologics

Sr. Scientist / Sr. Specialist for Biologics Production, CMC Biologics

Are you an experienced Subject Matter Expert (SME) looking to join Biologics Production? And do you want to work with commercial Drug Substance (DS) in an international setting, where empowerment and cross functional collaboration skills are key? Then you might be the new colleagues we are looking for.

Your new role – why is this a great opportunity?

Here at Lundbeck, we are one of the only pharmaceutical companies in the world focusing exclusively on brain diseases, and we are tirelessly dedicated to restoring brain health, so every person can be their best. Our project pipeline is progressing well, and CMC Biologics is engaged in multiple high priority projects in both early-stage and late-stage development.

In this role, you will be a SME in downstream DS commercial manufacturing, engaged from development handover to the full responsibility for the oversight of commercial manufacturing for CMC Biologics. You will work in close collaboration with colleagues across the organization and in close contact with Contract Manufacturing Organizations (CMOs), who is doing all commercial manufacturing for CMC Biologics

The Position

As a downstream SME, you will work out of the headquarter in Valby, Copenhagen, and you will report to the Senior Director for Biologics Production.

Your key responsibilities will include:

• Being a specialist in mammalian commercial downstream manufacturing
• Being an active member of the Biologics production team and together with colleagues having oversight of all commercial production.
• Managing and working closely together with global CMOs, providing technical oversight to commercial production.
• Making sure production campaigns are completed according to plans and fulfilling quality and regulatory expectations.
• Work close together with internal stakeholders like QA, QC, Regulatory affairs, Supply chain and finance.
• Contribute to general technical, scale up- and production strategies.
• Collaborate with CMC Biologics organization in bringing new products into commercial manufacturing.
• Being able to identify and drive areas for continuous improvement as it relates to manufacturing of biologics.
• Some travelling must be expected; in average, 1-2 travels abroad pr. year, to visit CMO´s.

This position is a great development opportunity where you will be part of defining future manufacturing strategies of biologics within Lundbeck and work in an exciting interphase with various internal and external stakeholders.

Your future team

In CMC Biologics we are more than 100 colleagues, split between Lundbeck Headquarters in Copenhagen and Lundbeck CoE in Seattle. Biologics Production is based in Copenhagen, Denmark working closely together with the Corporate Quality organization, also based in Valby.

Your colleagues are all experienced SMEs, and together you will cover DS commercial manufacturing for Lundbeck biologics products.

In Lundbeck, we strive to develop new innovating treatments to improve the lives of patients living with brain diseases. CMC Biologics support the development and production of new Biologics drug candidates for diseases like Migraine, Parkinson’s, and Alzheimer’s.

Established CMC Biologics focus teams and working groups are responsible for the continued development of Lundbeck’s Biologics candidates and are working into global project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, and Commercial.

To accommodate to time zone differences between teams in Copenhagen and Seattle, we reduce the late meetings via maintaining a primary meeting band in the calendar and via applying a geographical proximity, when working with our global CMOs.

What you bring to the team

You hold a Master or PhD in engineering, chemistry, biological science or equal. In addition, you preferably bring 3+ years in Biotechnology or Pharmaceutical manufacturing as well as experience from working with CMOs.

Furthermore, you have the following skills:

• SME knowledge about downstream DS manufacturing.
• Experience with DS commercial manufacturing.
• Desire to be working within cGMP requirements (regulations and guidelines) and cGMP quality systems.
• Fluently in English (Danish will be a benefit but is not a must)
• Good communication and stakeholder management skills
• Experienced with working in an international setting with different cultures.
• A team player with a positive attitude, a can-do approach, structured and good at planning own work. 
• Manages ambiguity and thrives in a dynamic and changing environment.

Candidates fulfilling most but not all the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications.

Our promise to you

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative. We are dedicated to 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 as our new colleague in Biologics Production?

Then upload your CV and include 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, please feel free to contact Kenny Jessen, Senior Director of Biologics production, on KEJN@Lundbeck.com

Applications must be received no later than April 30th, 2024, and application review and interviews will be conducted on an ongoing basis.

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.