Overseeing Analytical Development actives for our Gene Therapy products• Designed, developed, and executed analytical chromatography and biophysical characterization methods (HPLC, CE, cIEF, and LC-MS) for quantifying and characterizing molecular targets in gene therapy and cell therapy manufacturing and testing, enhancing analytical capabilities.• Developed, validated, and transferred phase-appropriate analytical methods to CDMOs for starting materials, in-process control, DS, and DP testing related to protein, RNA, and lipid nanoparticles, ensuring compliance with phase-specific requirements.• Reviewed CMC sections of regulatory submissions in collaboration with cross-functional groups, contributing to successful regulatory documentation and compliance efforts.

• Led development and execution of studies characterizing AAV-based gene therapy product for Duchenne muscular dystrophy (DMD) using HPLC, LC-MS/MS, CE-SDS, and cIEF (R and NR), supporting product characterization, formulation development, process development, and manufacturing.• Oversaw analytical activities of external vendors for preclinical and Phase I-II CMC activities involving drug substance and drug product, ensuring alignment with project goals and compliance standards.• Participated in development and revision of product specifications. Provided scientific input and critique of analytical results, contributing to robust product quality and regulatory readiness

• Oversaw the Verification and Validation of LC-MS assays for IVD use and supported sustaining of current IVD products, ensuring compliance with regulatory standards and maintaining product quality.• Designed studies, prepared samples, and processed data for LC-MS/MS studies in bioanalytical chemistry, enhancing assay development and analytical accuracy.• Collaborated with FDA on approval of neonatal LC-MS screening solutions from dried blood spots, achieving regulatory milestones and expanding clinical testing capabilities.

Development of mass spectrometry based solutions and assays for in vitro diagnostic use. • Bioanalytical method development for LC-MS/MS based solutions.• Experience in bioanalytical chemistry including study designing, sample prep, and data processing for LC-MS/MS studies.• Ability to independently troubleshoot assay methods and instrument failure• Integration and verification of robotic sample handling with LC-MS and other technologies• Support CMC analytical activities for IVD kits• Developed project plans and schedules for scientific activities • Experience with FDA 510K submissions, GLP, CLIA, CLSI and ISO regulatory

• Applied novel bioanalytical techniques in small molecule, peptide and protein quantitative LC-MS, advancing analytical capabilities and supporting research and development efforts.• Transferred methods and technology to manufacturing, enabling scale-up and integration of analytical processes, and improving production efficiency and consistency.Supported CMC activities for assays and solutions

Bioanalytical methods development for proteomic/ metabolomic technologies, techniques and workflows