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Senior Quality Control Specialist

2 weeks ago

Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

Career Opportunity

H. Lundbeck A/S is a leading global player in the treatment of brain diseases. We are currently seeking a Senior Quality Control Scientist to join our CMC Biologics team.

About the Position

This role will involve technical leadership and subject matter expertise in quality control activities, with a focus on drug-device combination products. You will work closely with cross-functional teams, including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs.

  • Develop and implement quality control strategies and procedures.
  • Collaborate with CMOs to plan, implement, and finalize QC relevant activities.
  • Review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories.
  • Support regulatory filings and interactions with Health Authorities.

About the Team

The CMC Biologics team is responsible for ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III. The team is located in Copenhagen, Denmark, and works closely with the Process Development Center of Excellence in Seattle, WA, USA.

Requirements

  1. A bachelor's degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or an equivalent field.
  2. Minimum 5 years of experience in the biotech or pharmaceutical industry, with a focus on drug-device combination products.
  3. Advanced English verbal and written communication skills.
  4. Good understanding of GDP/GMP guidelines and knowledge of the United States Pharmacopoeia and the European Pharmacopoeia.
  5. Understanding of methods used to test biological molecules, such as SE-H/UPLC, CE-SDS, icIEF, soloVPE, and potency ELISA.

We Are Looking for

A highly skilled Senior Quality Control Scientist with a passion for quality and a collaborative mindset. If you have a strong background in quality control and a desire to work in a fast-paced environment, we encourage you to apply.