iBio Consulting

Analytical Strategy for Biologics: Expert in designing end-to-end analytical frameworks that guide complex biologics from development through commercialization. Protein Characterization & Mass Spectrometry: Deep hands-on experience with advanced techniques like LC-MS and LC-MSMS for solving high-stakes structural challenges. Regulatory Submission Support: Proven success in preparing and reviewing analytical sections for INDs, BLAs, and other global regulatory filings. GxP Compliance & Quality Integration: Strong track record of aligning scientific operations with cGMP standards and working closely with QA to ensure audit readiness. Scientific Leadership & CRO/CDMO Oversight: Led high-performing teams and managed global vendor partnerships, driving quality outcomes, operational efficiency, and strategic alignment.