Yuki Weber

• Analytical lead for the CRMA-1001 (HBV epigenetic silencing) program, owning analytical strategy across drug substance and drug product, interfacing between CMC, Regulatory, and external CDMOs. • Analytical interface to external CDMOs, overseeing method transfer, qualification, validation, and lifecycle management • Lead author and SME for regulatory-facing content, including health authority RFIs, related to analytical assays, impurity control and safety justifications. • Analytical strategy ownership across DS and DP • Cross-functional leadership across Analytical, PD, Regulatory, QA, and Manufacturing

• Managed and mentored scientists supporting analytical development for lipid, mRNA, gRNA, and LNP modalities • Stability program lead, designing and executing phase-appropriate non-GMP stability studies to support formulation and shelf-life strategy • Developed and externally transferred critical HPLC assays to GMP testing laboratories • Led implementation of in-house mass spectrometry capabilities for lipid and RNA characterization

Led a team of two scientists responsible for LC-MS–based analytical methods supporting preclinical gRNA, mRNA, and LNP programs. Drove impurity control strategy development by interpreting FDA/ICH guidance and translating regulatory expectations into analytical testing approaches. Developed gRNA impurity identification assays on LC-QToF platforms in direct response to agency feedback; co-authored IND briefing documents and IMPD analytical sections. Led cross-functional matrix teams to optimize and statistically qualify biophysical assays (e.g., LNP apparent pKa), including automated data analysis pipelines. Established company-wide analytical data integrity practices using Benchling ELN/LIMS, improving traceability and inspection readiness.

• Drug Product Analytical Team Lead • LNP and mRNA characterization and method development • Semi-targeted ribonucleotide analysis by LC-HRMS (Q Exactive)

• Analytical development support for formulation R&D • Responsible SME for small molecule applications on Thermo Fisher Q-Exactive Orbitrap and Vanquish UHPLC platforms • Developed sample prep protocols for lipid nanoparticle formulations of mRNA

• Developed LC-MS/MS methodology for robust analysis of glycolipids of microbial cell culture • Overhauled previous biomarker extraction pipeline, increasing sample throughput 5 fold while cutting solvent usage by 90% • Set up benchtop bioreactor systems for continuous microbial culture, and developed sampling and quality assurance strategies for microbial lipidomics and metabolomics • Developed a protocol for staining and direct flow-cytometric counting of sub-micrometer microbial cells • Streamlined protocol for stable hydrogen isotope analysis of ether lipids, doubling recovery and sample throughput

• Revealed inherent biases in previous wet-lab protocol and designed an improved procedure leading to 3x higher extraction yields for certain bacterial lipids • Discovered novel bacterial biomarker by high-resolution HPLC-MS, leading to 50+ peer-reviewed scientific citations since 2015 • Designed and published an ‘R’ package for statistical analysis on environmental DNA sequencing data (https://github.com/yukiweber/phylo.lipids) • Leveraged interpersonal skills to resolve conflict between collaborators, resulting in a joint high-impact paper in PNAS

• Organized field sampling campaigns to remote areas in Mexico and Kazakhstan under strict time constraints, providing new scientific insights that lead to 3-year lab grant renewal • Developed wet-lab procedure for elemental analysis of complex soil samples using sequential chemical degradation and ICP-OES under strict cleanroom conditions