Senior Scientist
AstraZeneca
- Frederick, MD
- Permanent
- Full-time
- Lead Technology Transfer activities including: fit-to-plant, process risk analysis, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, and investigation support.
- Design and support lab-scale experiments to support process improvement projects and/or resolve manufacturing deviations.
- Make detailed observations, analyze data, and interpret results. Likewise, effectively present results at internal meetings and external scientific meetings.
- Author/review technical reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data.
- B. S in a scientific field
- Minimum 10yrs of relevant experience
- Demonstrate specific upstream cell culture unit operation knowledge in support of clinical/commercial bioprocessing of large molecule biologics (cell culture expansion, production bioreactor, harvest, cell culture scale-down models).
- Previous upstream Technology Transfer (TT) or process development experience.
- Knowledge of GMP manufacturing principles and documentation
- M.S w/ 8yrs of relevant experience
- PHD w/ 6yrs of relevant experience
- Process development experience
- Previous experience with statistical analysis and/or modeling: JMP, Minitab, SIMCA, and/or Discoverant.
- Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to TT