Paola Tedeschi

Serve as QC interface for analytical laboratories, project teams, and external customers in cross-functional environments. Lead QC activities for a key monoclonal antibody program approaching FDA BLA submission, preparing the QC pre-approval readiness package.

Taught chemistry at a secondary school in Lugano, Switzerland.

Managed external testing partners, ensuring testing continuity, investigation follow-up, and timely resolution of unexpected results. Led deviations and laboratory investigations, including impact assessment, root cause analysis, CAPA definition, and closure.

Supported the QC Head in ensuring compliant, efficient, and timely execution of laboratory testing activities. Monitored QC KPIs, facilitated team meetings, and coordinated communication with internal and external stakeholders.

Supported LC-MS method development for nitrosamine detection in finished drug products.

Performed and reviewed analytical documentation in compliance with TMs, SOPs, and cGMP requirements. Supported QC operations to ensure compliant, cost-effective, and efficient laboratory performance.

Performed in-process controls and release testing of raw materials and finished drug products according to TMs, SOPs, and cGMP.

Performed in-process controls and release testing of raw materials and fermentation-derived drug substances after semi-synthetic modification.

Developed QSAR predictive models to support the identification of new lead compounds.

PRINCE2 Project Management Foundation Certification obtained in 2024.

Diploma in Upper Secondary Education with a focus on Chemistry, completed in 2024.

Investigation Certification obtained in 2020.

Train the Trainer Certification obtained in 2019.

Grade: 110/110 cum laude

Master's degree in Medicinal Chemistry with honors (110/110 cum laude) from Università degli Studi di Bari.

Grade: 100/100

High School Diploma with a score of 100/100 from Liceo Classico 'C. Sylos' in Terlizzi.