Drug Product Specialist - Biologics Production

Lundbeck

  • København
  • Permanent
  • Fuldtid
  • 3 dage siden
Drug Product Specialist – Biologics ProductionAs a Drug Product Specialist in Biologics Production, you will play a pivotal role as a Subject Matter Expert (SME), ensuring excellence in biologics manufacturing and contributing to the success of our innovative treatments.Your new roleYou will act as the Subject Matter Expert for commercial biologics Drug Product manufacturing, overseeing global Contract Manufacturing Organizations (CMOs). Your responsibilities include:
  • Oversee the execution of commercial manufacturing at CMO´s
  • Provide technical support to commercial manufacture and act as Person in Plant when required
  • Support pre-commercial activities and the transition of project into the commercial portfolio
  • Review of the GMP manufacturing documents
  • Drive change controls and assessment of vendor/internal deviations
  • Support regulatory filings and interactions with Health Authorities.
This role offers a unique opportunity to take ownership of commercial Drug Product manufacturing from development to the end of lifecycle. You will collaborate with internal and external stakeholders to support Lundbeck’s growing biologics portfolio.Your future teamYou will join CMC Biologics, a organization of 115+ skilled colleagues located in Copenhagen and our Center of Excellence in Seattle, US. Reporting to the Senior Director for Biologics Production, you will work closely with a team of five experts responsible for commercial manufacturing of Drug Substance and Drug Product across a global CMO network.Collaboration is key to our success. You will work closely with cross-functional teams, including CMC Development, Corporate Quality Biologics QA/QC, and Regulatory Affairs, to ensure seamless production and product release. Expect 2-4 business trips annually to CMO partners in Europe and the United States.The position is based in Valby, Copenhagen.What you bring to the teamWe are seeking a candidate with a strong scientific background and a passion for biologics manufacturing. You should bring:
  • A Master of Science or PhD in pharmacy, chemistry, biological sciences, or a related field.
  • 3+ years of experience in Drug Product manufacturing, ideally in sterile fill-finish processes.
  • Knowledge of protein formulation, stability, and cGMP requirements.
  • A collaborative mindset, with the ability to work effectively in cross-functional teams.
  • A proactive attitude, ready to take on new challenges and expand your expertise.
Candidates who meet some but not all qualifications are still encouraged to apply, as the role can be adapted to suit your skills and career aspirations.Our promise to youLundbeck 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 nowCan 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 Kenny Jessen, Senior Director, at +45 30833966.Applications must be received by September 21st, 2025.Learn more about us , or Instagram (@h_lundbeck).#EveryBrainInTheGameThis 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.

Lundbeck