Senior Quality Control Professional

5 days ago


Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

About the Role

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As a Senior Quality Control Scientist, 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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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 Company

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CMC Biologics support the development and production of new biologics drug candidates for diseases like Migraine, Parkinson's, and neurohormonal dysfunctions.

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About the Department

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Your new department, Quality Control, is a team of experienced specialists, responsible for the quality of Cell Banks, Drug Substance, and Drug Product for all Lundbeck development biological projects.

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What We Offer

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Lundbeck offers numerous development opportunities that are balanced with initiatives focused on your well-being.

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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 need every brain in the game – and that includes all brains and the different perspectives we bring to the table.

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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.



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