• Aided in the identification and implementation of strategies for the analytical characterization, release, and stability testing of drug substance and drug product in compliance with regulatory requirements• Diligently monitored all GMP and non-GMP stability programs, compiled data, and performed statistical trend analysis to justify the assignment of shelf-life and retest periods• Coordinated and oversaw analytical testing performed at external contract organizations to ensure key milestones were met for the entire pipeline of pre-clinical and clinical candidates• Authored, updated, reviewed, and approved analytical and stability protocols, reports, and relevant sections of regulatory filings• Engaged the quality/regulatory team to align on and apply phase-appropriate control strategies and specifications • Supported comprehensive and timely qualification and recertification of reference material • Facilitated successful analytical method development, optimization, validation, qualification, and transfer activities at CROs/CMOs• Offered cross-functional support and provided analytical expertise for manufacturing and testing deviations, out of specification, and out of trend investigations

• Led all biophysical method development and characterization activities across discovery stage programs to enable lead candidate identification and selection• Managed day-to-day analytical operations at multiple contract organizations • Conducted in-house method development, troubleshooting, and testing as needed for clinical phase programs• Prepared for regulatory submissions by executing well planned experiments, generating SOPs, drafting study reports, and authoring/reviewing applicable IND sections• Critically reviewed analytical methods, protocols, reports, and data packets• Trained and mentored others on analytical methods, instruments, and techniques

• Supported protein characterization by leading SEC-HPLC and SEC-MALS operation, maintenance, experimental design, and analysis • Gained predictive insight about potential platform candidates by designing and performing thermal stability studies, DSF, and DSC experiments• Enhanced in-house biochemical and biophysical characterization capabilities by introducing new instruments and assays

• Developed, optimized, and executed kinetic binding assays to test a wide range of protein biologics for new and existing platforms • Performed orthogonal binding assays and techniques (such as Octet, ELISA, and Alphalisa) to better understand complex protein interactions • Strengthened the company’s data management and documentation capabilities by assisting with the implementation, maintenance, and expansion of a standardized ELN/LIMS platform

• Conducted in vitro cell based potency assays crucial to drug substance formulation• Generated accurate and reproducible findings from qPCR, SDS-PAGE, and in cell western blot evaluations of recombinant AAV samples• Maintained mammalian cell lines while demonstrating aseptic techniques• Carried out primer probe optimization to ensure the highest suitability• Produced comparable lots of plasmids, standards, and other essential materials for new and ongoing studies• Analyzed and interpreted results in a timely and efficient manner• Manufactured buffers, reagents, and media as necessary • Gained a deeper understanding of the gene therapy pipeline process

• Developed, established, and conducted plate-based biochemical assays• Purified monoclonal and polyclonal antibodies• Maintained, cultured, and tested Shiga toxin-producing E. coli• Executed proper coupling to and handling of magnetic and latex beads to optimize particle functionality • Interpreted experimental data, presented findings, followed appropriate documentation procedures • Performed troubleshooting experiments on existing products and issued new methods with SOPs as necessary • Carried out validation, precision, and stability studies to determine and assign accurate specifications