Quality Assurance Manager for Cell Banks and Drug Products

3 days ago


Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

Job Description

The Senior Quality Control Scientist will be responsible for leading Quality Control activities for biologics development, working closely with CMOs, and collaborating with cross-functional teams. This role requires strong leadership skills, technical expertise, and excellent communication abilities.

Key Responsibilities

  1. Lead Quality Control activities for biologics development, focusing on drug-device combination products
  2. Collaborate with contract manufacturing organizations (CMOs) for planning, implementation, and finalization of QC relevant activities
  3. Review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories
  4. Cross-functional collaboration with Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs teams
  5. Support regulatory filings and interactions with Health Authorities

Required Skills and Qualifications

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


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