Fabrizia Dangelo

Background

About Fabrizia Dangelo

Exstensive use of mass spectrometry based-methods for biotherapeutic proteins (mAb, glycoprotein and fusion protein) characterization and coordination of internal project and activities. KEY TASKS Definition of experimental design with the aim of qualifying MS-based method for biotherapeutic proteins (mAb, glycoprotein and fusion protein) structural characterization. Use of statistical tools to define acceptance criteria for comparability studies according to regulatory requirements. QC testing management. Support to QC specification setting for CQAs monitored in characterization mode. Support CQAs risk assessment. Drafting and revision of documentation in accordance to cGMP requirements (Notebook, logbook, study protocol, report, SOPs and regulatory document). Presentation and discussion of results with Laboratory Manager, external functions (QA, QC, CMC project team, Regulatory) and customers. Focal point activities through liaison with other laboratories, within the department, coordinating and taking into account the projects timelines. Actively participation in technical and cross-functional project teams ( project core team member) and contribution to overall strategies and goals. Projects coordination within the laboratory and the department