Our client is dedicated to bring innovative therapies or unmet medical needs to their patients. As a result everybody within this company is directly or indirectly responsible for the lives of patients. This responsibility is a part of their day-to-day working life as well as living up to the high quality standards and recognizing the sense of urgency in areas of high medical need.
As a Scientist Drug Product Development you will be responsible for the development activities pertaining to gene therapy drug products throughout their lifecycle. Overall you will play an important role in implementing the formulation platform and increase understanding of the physicochemical attributes of new gene therapy products, from the preclinical development phase up to market authorization.
- Timely and adequate writing of study protocols and reporting of study results
- Support Process Development, Analytical Development and Manufacturing on Drug Product related topics
- Support Non-Clinical and Clinical Development on compatibility topics
- Contribute to regulatory submission (IMPD, IND and dossier variations)
- Explore and establish novel analytical methodologies to characterize the product
- PhD in a Life Sciences related field with affinity for analytics or proven equivalent industry experience
- Proven scientific or technological background
- Affinity with hands-on work and physicochemical characterization of biologics preferable recombinant viruses
- Understanding of Process Development of biological products
- Knowledge of regulatory policies and guidelines regarding stability
- Familiarity with Good Manufacturing Practices in the biotechnical or pharmaceutical industry
- At least two years' of relevant working experience in a comparable position
For this position they are looking for an integer and detail oriented candidate.