Abdi İbrahim Pharmaceuticals (AbdiBio)
|AbdiBio R&D Bioanalytical Development Analyst
Istanbul, Istanbul, Türkiye
Summary
As AbdiBio R&D Bioanalytical Development Analyst, Emre orchestrates analytical method development and physicochemical characterization for biologics, ensuring regulatory compliance and data integrity for monoclonal antibodies.
Highlights
Led comprehensive analytical method development and qualification protocols for biologics within the Lot Release Assay team, ensuring robust and compliant testing procedures.
Executed high-precision structural and functional analysis of monoclonal antibodies (mAbs) across Drug Substance (DS), Drug Product (DP), In-Process Controls (IPC), and stability samples, delivering critical data for product quality.
Orchestrated end-to-end analysis using advanced chromatography (SE-HPLC, HIC-UPLC, ProA-HPLC) and electrophoresis (Non-Reduced CE-SDS) techniques, precisely quantifying protein aggregation, hydrophobicity, titer, and purity.
Managed full documentation lifecycles via Qmex, authoring Laboratory Procedures, Method Development, and Qualification Reports, ensuring stringent GMP/GLP regulatory compliance.
Spearheaded CAPA, Deviation Management, and Document Revision processes, maintaining high standards of quality assurance and data integrity across all analytical workflows, from sample preparation to final reporting.