Marousi, Attiki, Greece
I have 15+ years driving CMC programs from early-phase through GMP and commercial readiness across biologics and complex formulations. I build and lead high-performing analytical teams, design phase-appropriate control strategies, and align cross-functional stakeholders across Quality, Formulation, and Metrology — translating technical complexity into regulatory-defensible outcomes that move programs forward. My expertise spans method development, qualification, validation, and lifecycle management across a broad analytical platform — HPLC/UPLC, CE/iCIEF, SoloVPE, plate-based assays, SDS-PAGE, and compendial methods — applied to characterization, stability, and release testing. I have a track record of accelerating GMP readiness, including site startups and analytical infrastructure buildout, while maintaining inspection readiness and data integrity. My programs consistently deliver: faster method readiness, reduced technical risk, and clear data packages that support clinical progression and commercialization. Analytical Development leader with EU Blue Card status, offering immediate work authorization and seamless mobility across EU member states without visa sponsorship. Experienced in relocating and delivering impact across both US and EU environments, with a track record of rapidly integrating into new organizations and executing in high-growth and fast-paced settings.
Leading Analytical Development strategy for CMC programs, driving phase-appropriate method development, qualification, and readiness to support accelerated clinical timelines Partnering closely with Upstream (USP) and Downstream (DSP) teams to develop integrated analytical control strategies, enabling process understanding, characterization, and comparability assessments Designing and implementing robust, stability-indicating methods across key platforms (HPLC/UPLC, CE/iCIEF), ensuring data integrity and regulatory alignment Delivering against aggressive development timelines by prioritizing high-impact activities, optimizing workflows, and removing technical bottlenecks to maintain on-schedule program execution Leading cross-functional collaboration with Quality, QC, and Manufacturing to ensure seamless transition from development to GMP operations and clinical readiness Driving rapid method troubleshooting and investigation strategies, minimizing delays and ensuring continuity of critical path activities Enhancing team performance and accountability through structured execution frameworks, improving throughput, consistency, and first-time-right outcomes Supporting regulatory readiness by ensuring analytical methods and documentation meet global expectations for IND/IMPD submissions and inspections
Built and led a high-performing analytical team, improving project throughput and on-time delivery across multiple client programs Delivered pre-formulation, characterization, and stability studies supporting IND-enabling and clinical-stage programs Authored and approved 100+ analytical methods, protocols, and reports, ensuring compliance with GMP and global regulatory expectations Reduced equipment onboarding timelines by streamlining change control processes, accelerating GMP study readiness Designed customized analytical strategies aligned to molecule-specific risks, improving method robustness and reducing repeat testing Led complex investigations, resolving atypical results and minimizing project delays and data risk Supported regulatory inspections with zero critical observations, strengthening audit readiness Acted as primary client interface, delivering clear, data-driven updates and strengthening long-term partnerships Oversaw technical documentation (reports, CoAs), ensuring accuracy, compliance, and timely release
Supported EU site expansion, contributing to rapid GMP operational readiness within year one Improved team execution by aligning analytical workflows, increasing efficiency and delivery consistency across projects
Managed cross-functional CMC projects (formulation, stability, method development), delivering on-schedule results across multiple programs Led and developed junior scientists, improving team productivity and technical capability Authored SOPs, protocols, and specifications supporting standardization and regulatory compliance Optimized project planning and scheduling, increasing resource efficiency and reducing bottlenecks
Performs Inhalation Testing on Metered Dose Inhalers (MDI's), focusing on delivered dose uniformity (DDU), NGI (Next Generation Impactors), Shot Weight, and Total Can Assays for Assay and Impurity analysis via HPLC Performs Method Development, Validation and Qualifications on Content Uniformity and Delivered Dose Uniformity involving Dry Powder Inhalers (DPI’s)
Validates HPLC Methods for a variety of drug formulations (raw materials, patches, suspensions, sterile liquids, aerosols, and powders) Analyzes API’s, Raw Materials, In-Process & Finished Products for Assay & Related Substances via HPLC Prepares & Analyzes Proteins and Biological Samples via SEC-HPLC and ELISA Potency Assays Extensive Experience with Normal Phase, Reverse Phase, Ion Exchange, and SEC Writes analytical test methods, SOP’s, study protocols, investigational protocols and client reports Participates in teleconferences with sponsors Performs IQ/OQ/PQ for HPLC and Dissolution Baths Peer Review of Analytical Data Frequent Collaboration with senior scientists and formulators in a regulated cGMP environment
Performed release and stability testing using USP/NF and EP methods on intermediate and finished drug products; (HPLC assays for API, excipients, related substance, impurities and dosage uniformity in a cGMP environment) Performs USP method dissolution bath calibration for apparatus I, II, III, and VII & controlled-release drug substances Performed wet chemistry techniques; KF (Volumetric & Coulometric), Viscosity, Disintegration, pH, Specific Gravity testing Fulfilled method transfer and qualification protocol testing for various clients Assist team members in completing projects and completed individual work Safety committee member, controlled substance trained, and respirator trained