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Quality Management Expert in Biologics

2 weeks ago

Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

About the Role

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Are you eager to work in an international setting where empowerment and cross-functional collaboration skills are key? Do you want to join our international CMC Biologics Quality Control team?

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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, e.g., sampling plans, Certificate of Analysis, stability studies, method validation etc.">
  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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This position is a great opportunity where you will be part of a team ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team.

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About Us

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We are committed to building a workforce that is as diverse as the people we serve.