The department Analytical Development and Quality Control Biotech Europe is responsible for Biochemical and Biophysical Analytical Development, Quality Control and Compliance for Biopharmaceuticals from pre-Investigational New Drug (IND) to New Drug Application (NDA) and Launch.
The Scientist / Senior Scientist Analytical Development Biochemistry is responsible for:
- Serving as analytical lead for biotechnological development projects including the coordination of all necessary analytical activities to ensure efficient analytical project support and continuous improvement
- Representation of Analytical Development and Quality Control in global technical development Teams
- Evaluation, implementation, and further development of new technologies/ test methods to ensure state of the art analytical support for biotechnological dosage forms
- Quality control for investigational medicinal products and batches used in preclinical and clinical studies
- Setting of specifications and shelf life for investigational medicinal products and support of IND and BLA (Biologics License Application) filings
- Representing of analytical Research & Development aspects in local and global committees and working groups