Senior Scientist II Quality Control

138293
  • 60000 EUR - 90000 EUR
  • Berlin, Germany
  • Permanent

An exhilarating opportunity awaits at a dynamic mid-sized clinical-stage biotech company that seeks a Senior Scientist in Quality Control for their Berlin site. This international company boasts a robust pipeline in various therapeutic areas and, owing to their triumphs in clinical trials, is expanding across diverse teams. They are actively seeking skilled professionals in the field of gene therapy. As a Senior Scientist in Quality Control, your responsibilities will include directing method lifecycle processes, supervising operations at CMOs, and functioning as an expert with GMP standards.

 

Key Responsibilities:

  • Provide expertise in analytics, GMP QC practices for raw materials and RNA compounds
  • Deliver analytical methods supporting drug development & commercialization
  • Review and approve Method Development, Transfer, and Validation Documentation, develop Stability Protocols
  • Handling of deviating analysis and lead the development of analytical control strategies
  • Ensure timely and budget-conscious execution of project activities
  • Generate and archive CMC regulatory documentation for INDs/IMPDs

 

Requirements:

  • Advanced Degree (PhD preferred) in Chemistry or Biochemistry
  • Minimum of 7 years of hands-on experience in GMP QC
  • Experience in chromatographic and spectrometric methods (HPLC MS and UV)
  • Extensive experience in analytical method lifecycle, development, qualification, transfer, and monitoring
  • Background in establishing and maintaining stability studies for therapeutic products
  • Preferred experience in working with CROs/CMOs
  • Strong collaborator and team player
  • Desire to broaden experience and contribute to organizational growth
  • Fluent in English; German is advantageous

 

Please contact me at +49 30 767580488 or elif@peoplewithchemistry.com if you would like to learn more about this opportunity. We guarantee absolute confidentiality during our discussions.

Elif Oguz Recruiter

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