Pascal Monczka

• Manage client projects in the biopharmaceutical sector, ensuring alignment of project scope, timelines, quality and budget • Serve as primary client contact, leading project meetings and coordinating communication between scientific, technical, regulatory and business stakeholders • Coordinate cross-functional teams to ensure successful execution of analytical programs including forced degradation studies and impurity characterization • Support analytical programs generating data for regulatory submission

• coordinated client projects including planning of timelines, milestones and resource tracking • Monitored project progress and coordinated with internal teams to ensure timely execution of project activities • Managed work packages within larger projects and facilitated communication between scientific, technical and business stakeholders • Coordinated project logistics • Maintained project documentation and reporting including project plans, status updates and budget tracking

• Performed GMP-compliant analytical testing for monoclonal antibodies (mAbs), proteins and other biologics using cGE, icIEF and IEX-HPLC • Supported method validation and qualification of capillary electrophoresis–based analytical methods • Conducted analytical testing across multiple development stages, including analytical development, QC testing and release testing • Maintained and qualified analytical instrumentation in accordance with GMP requirements

• Performed capillary electrophoresis (cGE, icIEF) and chromatographic analyses (IEX-HPLC) including data evaluation, interpretation and technical reporting • Worked in a GMP-regulated environment, ensuring GMP-compliant documentation and data integrity • Contributed to multiple project types including stability studies, clone selection studies and analytical characterization • Utilized analytical software including Empower (Waters) and 32Karat (SCIEX) for data acquisition and analysis

• Performed quantification of glycolipids in complex mixtures using HPLC-MS • Conducted quality control analyses using GC-MS • Generated and evaluated analytical data to support routine laboratory testing

Internship (22-week practical semester) – Analytical Laboratory • Supported analysis and interpretation of analytical data from complex mixtures • Performed independent sample preparation and analytical measurements • Contributed to validation of analytical methods in quality control and routine analytics • Gained hands-on experience with HPLC-MS and GC-MS • Performed UV/Vis spectroscopy and turbidity measurements for analytical characterization