Scientist, Biopharma Data Analysis
13 days ago
Full time role
In-person · Bern, BE, CH
- Plan, execute, and report impurity profiles and impurity-based comparability studies for manufacturing process changes and process transfers
- Perform impurity profile data control, statistical impurity profile data evaluation and correlation analyses to support deviations and process changes and update tracking tools
- Prepare presentations to support investigations related to process changes, process improvements, deviations/quality issues, and general impurity knowledge
- Prepare of impurity profile data to support data management
- Support storage and control of impurity profile retain samples
- Support global regulatory affairs in impurity profile field by updating impurity chapters in registration dossiers and responding to inquiries from authorities
- Ordering of plasma product samples and planning sample analyses with other departments
- Participate in local and global projects