• Managed 4 gene therapy products targeting 6 IND/CTA submissions and future BLA/MAA filings for AAV gene therapies for rare CNS diseases.
• Held 4 Health Authority meetings (FDA, MHRA, HC), organized meeting logistics, and recorded official minutes.
• Developed PM tools to establish Regulatory Affairs PMO (dashboards, timelines, registries, etc.).
• Managed internal face-to-face gatherings and problem-solving workshops.
• Tracked Regulatory Affairs vendor budget.

• Managed the on-time closure of 27 CAPAs in 6 months for an FDA 483 successfully resulting in Voluntary Action Indicated classification. Supported launch of subsequent inspection readiness program.
• Managed up to 7 concurrent cross-functional AAV gene therapy projects scoped up to $2.4M in budget. Projects included post-approval commitments, post-merger integration, change programs, method validation, method transfer, alliance development, site filing readiness, & commercial QC operations

• Managed 19 contract MFG, QC, and stability projects for Phase I/II biologics for on-time and under budget delivery. • Compiled, reviewed, and consulted on CMC documentation for health authority submissions (IND, ARs, etc.). • Responsible for CRO/CDMO management, outsourcing, and client customer relations for stability and QC programs. • Developed a new stability program monitoring system leading to implementation in 10 studies. • Managed 2 direct reports. Served as subject matter expert (SME)

• Performed and reviewed cGMP QC testing for clinical phase biologics and novel therapies.
• Developed and validated new analytical methods (bioassays, large molecule HPLC, protein chemistry, etc.).
• Held QC Lead role for scheduling and managing CMO product testing.

• Researched HIV-1 gRNA trafficking, polarized assembly, and comparative nuclear export pathways contributing to 1 publication in the Journal of Virology.
• Coordinated launch of the Sherer Lab for new Principal Investigator. Managed laboratory operations.