This organization is focused on Gene Therapy to treat immunological diseases. Gene Therapy uses genes to treat diseases by deleting, adding or altering DNA, this way it targets the root cause of the problem instead of just treating the symptoms. This firm uses viruses and vectors to get into the cell to deliver the new copy of the gene into a cell.
As a Scientist Drug Product Development you will be responsible for developing formulations of gene therapy products considering stability issues and primary packaging and devices.
- - Design, plan, supervise and report formulation, stability, characterization, and compatibility studies
- - Writing of study protocols and reporting of study results
- - Support Process Development, Analytical Development and Manufacturing on Drug Product related topics throughout product lifecycle
- - Support Non-Clinical and Clinical Development on compatibility topics
- - Contribute to regulatory submissions (IMPD, IND, dossier variations)
- - Explore and establish novel analytical methodologies to characterize the product from a physicochemical viewpoint.
- - PhD in Life Sciences with affinity for analytics (HPLC, spectrophotometry, molecular biology...)
- - 2+ years of experience in a similar role
- - Affinity with hands-on work
- - Affinity with physicochemical characterization of biologics preferably recombinant viruses
- - Understanding of process development of biological products
For more information please contact Carla Garcia at +31 (0) 20 658 98 01 or firstname.lastname@example.org.