Greater Istanbul
When our pharmaceutical facility underwent a major relocation in 2020, I took on a challenge that would define my career: establish a biopharmaceutical quality control laboratory in our new production facility. We transferred equipment from our R&D site and adapted existing methods, but everything needed requalification, optimization for the new environment, and GMP compliance documentation built from scratch. Over the next 18 months, I transformed that space into a fully operational analytical hub. I led the requalification of 11 analytical instruments, developed and validated 25+ methods for monoclonal antibody characterization, and authored over 200 quality documents that now support regulatory submissions across multiple biosimilar programs. The experience taught me something invaluable. I don't just run analytical methods; I architect analytical strategies that enable drug development. My expertise centers on the physicochemical characterization of therapeutic antibodies. I work across the full analytical toolkit: size exclusion and ion exchange chromatography, capillary electrophoresis, and mass spectrometry-based techniques including peptide mapping, intact mass, and glycan profiling. But beyond the techniques themselves, I focus on what they reveal: understanding degradation pathways through forced degradation studies, demonstrating biosimilar comparability, and building the analytical foundation that takes molecules from development through regulatory approval. My PhD research on monoclonal antibody behavior under stress conditions gave me the scientific foundation, but nine years in industry taught me how to translate that science into practical solutions. I've published 9 peer-reviewed papers (including work on therapeutic antibody characterization and forced degradation studies), prepared analytical sections of CTD Module 3 for regulatory submissions, and mentored junior scientists in both technical execution and regulatory thinking. I'm now exploring opportunities to join an innovative biopharmaceutical organization in Europe or North America where I can contribute to analytical method development and biosimilar programs. I'm particularly drawn to environments where analytical scientists work closely with formulation and process development teams, where we're not just generating data, but actively shaping development strategy. If you're building analytical capabilities for antibody-based therapeutics, ADCs, or next-generation biologics, I'd welcome a conversation.
Leading analytical testing strategy for therapeutic monoclonal antibody programs, including biosimilars and novel candidates, from early development through regulatory submission. Responsible for stability program management, CTD preparation, method deployment, and cross-functional collaboration with Process Development and Regulatory Affairs teams. - Designed and executed analytical testing strategy for 5 therapeutic mAb products across drug substance and drug product development, coordinating 24-month stability programs (ICH Q1A) that support IND/CTA submissions for clinical trials - Authored analytical sections of CTD Module 3 (Quality) for multiple regulatory submissions, ensuring compliance with ICH Q6B specifications - Led analytical method deployment during 5+ engineering runs, implementing risk-based approach to method suitability and OOS investigations that reduced testing turnaround time by 30% - Collaborated with Process Development and Regulatory Affairs teams to resolve complex analytical challenges, providing technical recommendations that accelerated 2 development programs toward clinical trials - Mentored team of 3 analytical scientists in advanced characterization techniques (LC-MS/MS, CE-SDS, SEC) and regulatory expectations for GMP environments
Led the establishment and operation of a biopharmaceutical QC laboratory during facility relocation, managing equipment transfer, method validation, computerized system validation, and GMP documentation. Responsible for comprehensive mAb characterization, forced degradation studies, stability programs, and routine quality control operations supporting both development and commercial programs. - Established biopharmaceutical Quality Control Laboratory from ground-up during facility transfer, led equipment requalification from R&D site, developed and validated 25+ analytical methods (SEC, CE-SDS, cIEF, LC-MS/MS peptide mapping, intact mass, N-glycan profiling, disulfide mapping) following ICH Q2(R1) guidelines, and successfully transferred 15+ methods ensuring analytical equivalence - Led computerized systems validation (CSV) for 11 analytical instruments ensuring 21 CFR Part 11 complianc, authored over 200 quality documents including SOPs, method descriptions, validation reports, and instrument qualification protocols that established complete GMP infrastructure - Designed and executed comprehensive forced degradation studies under thermal, oxidative, freeze/thaw, and pH stress condition, identified critical degradation pathways for multiple mAb candidates and developed stability-indicating methods - Managed 24-month stability programs for 3 therapeutic products (ICH Q1A), coordinated testing schedules, trending analysis, and stability reporting for regulatory submissions - Authored 15+ analytical method development and validation reports that achieved first-time regulatory acceptance demonstrating robust method design and thorough validation protocols - Performed comprehensive QC operations including raw material testing (cell culture media, excipients), compendial methods (subvisible particle, TOC, Raman), and Ph. Eur. medical gas analysis, maintaining full analytical capability for biopharmaceutical production
Performed analytical characterization of therapeutic monoclonal antibodies for biosimilar development programs, focusing on physicochemical comparability assessments and quality attribute analysis. Contributed to regulatory submissions through orthogonal analytical testing and comprehensive data package generation. - Performed comprehensive mAb characterization using SE-UPLC (size variants, aggregates), CE-SDS (purity analysis), and cIEF (charge profiling), establishing analytical expertise across multiple orthogonal techniques for therapeutic protein characterization - Led analytical comparability assessments for 5+ biosimilar candidates, demonstrated equivalence to originator products across multiple critical quality attributes using systematic, multi-method approaches that supported regulatory strategies - Generated high-quality analytical data packages meeting ICH Q6B specifications, contributed to successful regulatory submissions by ensuring data integrity, method robustness, and comprehensive product characterization - Developed technical proficiency in method execution and troubleshooting that formed the foundation for subsequent method development and validation leadership roles
Assisted in laboratory practices of Faculty of Medicine, Department of Molecular Biology and Medical Laboratory Technician Program.