Biological Quality Assurance Specialist

5 days ago


Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

About the Role

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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 Lundbeck's development biological drugs from Phase I to Phase III.

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Key Responsibilities

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

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In CMC Biologics, we are more than 100 employees, split between Lundbeck Headquarters in Copenhagen, Denmark and Lundbeck Process Development Center of Excellence in Seattle, WA, USA. Most of the teams in the CMC Biologics organization have employees based in both Copenhagen and Seattle; this is also the case for your new department, Quality Control.

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What We Offer

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Lundbeck offers an inspiring workplace, passionate colleagues, and a culture characterized as collaborative – a must to bring our treatments through research and development all the way to commercialization and the people who need them.

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About You

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You are a highly skilled Senior Quality Control Scientist with minimum 5 years of experience in the biotech or pharmaceutical industry. You have an accredited bachelor's degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal. In addition, you bring:

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  1. ">
  2. Experience in drug-device combination products">
  3. Good understanding of GDP/GMP guidelines">
  4. Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia">
  5. Understanding of methods used to test biological molecules">
  6. Advanced English verbal and written communication skills">
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Your Future Career

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We aim to reduce late meetings to a minimum by maintaining a primary meeting band in the calendar and by applying a geographical proximity, when working with our global CMOs.

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The position is based in Valby, Copenhagen - Denmark.



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