Sofie is working as a project lead of a CMC (Chemistry manufacture Control) project within EU’s IMI (Innovative Medicine Initiative) Enable, which assignment is to develop new therapies against antibiotic resistance. The object of the CMC project is to perform process development and manufacture of drug substance and drug product to be used for preclinical and clinical trials and to prepare the GMP strategy as well as the basis of the IMPD (Investigational Medicine Product Dossier).
Sofie is also working with formulation of colloidal preparations mainly for substances for to preclinical and clinical trials and she is also certificated for manufacturing in GMP environment.
Sofie has long experience of manufacturing of biological substances in commercial scale, such as tech transfer, qualification and validation, change control and deviations, authorities, GMP and lab supportive studies within protein purification (columns and ultrafiltration).
Sofie has also great experience of project management of large and complex project like introduction of commercial biological processes.
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