Leading Quality Assurance Specialist for Biologics Development

9 hours ago


Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

We are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics team at H. Lundbeck A/S in Copenhagen, Denmark.

About the Role

This is an excellent opportunity for a seasoned professional to take on a key position in ensuring the quality of our development biologics drugs from Phase I to Phase III.

As Senior Quality Control Scientist, you will be responsible for technical leadership and subject matter expertise for Quality Control activities with a focus on drug-device combination products.

  1. You will work closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities, such as sampling plans, Certificate of Analysis, stability studies, method validation, etc.
  2. Review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories.
  3. Collaborate within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs.
  4. Support regulatory filings and other interactions with Health Authorities.

This role offers a great opportunity to be part of a team that ensures the quality of our development biological drugs, working in close collaboration with global partners.

About You

To succeed in this role, you should have a minimum of 5 years of experience in the biotech or pharmaceutical industry, with an accredited bachelor's degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal.

  • Experience in drug-device combination products.
  • Familiarity with GDP/GMP guidelines.
  • Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia.
  • Understanding of methods used to test biological molecules (e.g., SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA).
  • Advanced English verbal and written communication skills.

A salary in the range of €90,000 - €110,000 per year, depending on experience, is offered for this challenging position.

We are committed to creating a diverse and inclusive workplace that values employee well-being and growth opportunities.



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