Senior Quality Control Specialist

1 month ago


Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time
About the Role

We are seeking a highly skilled Senior Quality Control Scientist to join our international CMC Biologics Quality Control team. As a key member of our team, you will be responsible for ensuring the quality of our development biological drugs from Phase I to Phase III.

Key Responsibilities
  1. Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products.
  2. Collaborate with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities.
  3. Review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories.
  4. Collaborate within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs.
  5. Support regulatory filings and other interactions with Health Authorities.
About the Team

Our CMC Biologics team is a global organization with over 100 employees, split between Lundbeck Headquarters in Copenhagen, Denmark and Lundbeck Process Development Center of Excellence in Seattle, WA, USA. As a Senior Quality Control Scientist, you will work out of our headquarters in Valby, Copenhagen, and report to the Senior Manager Quality Control.

Requirements
  1. Minimum 5 years of experience in the biotech or pharmaceutical industry.
  2. Accredited bachelor's degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal.
  3. Experience in drug-device combination products.
  4. Good understanding of GDP/GMP guidelines.
  5. Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia.
  6. Understanding of methods used to test biological molecules.
  7. Advanced English verbal and written communication skills.
About Lundbeck

Lundbeck is a global pharmaceutical company that is passionate about improving the lives of people affected by brain disorders. We offer a collaborative and dynamic work environment, with opportunities for career development and growth.

We are committed to building a diverse and inclusive workforce, and we welcome applications from candidates from all backgrounds.



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