Scientist - Biopharma Data Analysis / Management

about 1 month ago
Full time role
In-person · Bern, BE, CH... more
  • Build up of reference data base according to impurity standards in collaboration with Data Management Team
  • Plan, execute, and report impurity profiles and impurity-based comparability studies for manufacturing process changes and process transfers
  • Support in information gathering of product and process knowledge (generation of flowcharts, deviation history, etc.)
  • Support in defining and organizing future sample management procedure
  • Support definition and alignment of impurity profile analytical testing program
  • Prepare presentations to support investigations related to process changes, process improvements, deviations/quality issues, and general impurity knowledge
  • Support global regulatory affairs in impurity profile field by updating impurity chapters in registration dossiers and responding to inquiries from authorities
  • Participate in local and global projects