Key achievements in Biotechnology and Pharma industry experience, specific tools and techniques, collaborative and leadership roles: • CMC Analytics Expertise: Led analytical method development and preclinical assessment of recombinant proteins and monoclonal antibodies (mAbs), focusing on the characterization and monitoring of Critical Quality Attributes (CQAs) using cutting-edge UHPLC/UPLC technologies. • Protein Engineering & Antibody Technologies: Designed and optimized recombinant proteins and therapeutic antibodies, leveraging rational design strategies to enhance functionality and developability. Proficient in antibody humanization, affinity maturation, and Fc engineering for improved efficacy. • Upstream and Downstream Processing: Extensive experience in scaling biomanufacturing processes for mAbs, including cell culture optimization (CHO/Sf9) and downstream purification techniques such as Protein A/G chromatography, ion-exchange chromatography, and size-exclusion chromatography (SEC). • Quality Control (QC) and Regulatory Compliance: Established and validated QC processes to ensure compliance with ICH guidelines and Good Manufacturing Practices (GMP) for preclinical and clinical biologics. • Preclinical Developability Assessment: Successfully conducted stability studies, aggregation analysis, glycosylation profiling, and immunogenicity prediction for mAbs in early-stage R&D pipelines. • Analytical Technologies: Advanced proficiency in mass spectrometry (MS), dynamic light scattering (DLS), capillary electrophoresis (CE), and peptide mapping, ensuring the comprehensive analysis of therapeutic proteins. • Collaborative Contributions: Played a pivotal role in cross-functional teams, bridging R&D, process development, and regulatory functions to accelerate project timelines and deliver high-quality therapeutic candidates. • Industry Leadership: Worked with leading Biopharma and Biotech companies, driving innovations in mAb discovery, production, and QC while maintaining an acute focus on patient safety and product integrity.https://www.ticinoscienza.ch/cerca.php