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Manager Stability & Release Analytics (m/f)


  • As a member of the CMC team assign and monitor all work orders for stability studies and batch release testing at external partners according to the respective project's need
  • Establish stability protocols, procure compliant data packages; extrapolate data, write final stability reports
  • Perform batch tracking for release testing and stability studies
  • Perform all statistical/trending evaluations for submissions or marketed products
  • Contribute stability and batch results to regulatory documents, propose shelf-live and stability statements
  • Support Analytical R&D to devise appropriate conditions for e.g. stress, in-use, and compatibility testing
  • PhD or MSc in chemistry or pharmacy with minimum 5 years of experience in managing stability studies and batch release testing, including marketed products
  • Knowledge in stability evaluation and QC testing related to commercial products
  • Authoring quality related sections of regulatory documents
  • Profound GMP knowledge is required, broad experience in analytical test methods is an advantage
  • Fluent in written and spoken English, German would be advantageous
  • Good IT-user skills in MS-Office programs and statistical evaluation


—> Job description


Employer:
Basilea Pharmaceutica Ltd.
Location:
4005 Basel [CH]

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