-Drives Submission Readiness for BLA for product candidate, lifileucel for metastatic melanoma. Program has the potential to become the first approved one-time cell therapy for a solid tumor cancer
-Created BLA dashboard to track doc status for Module 1-5 that links SmartSheet timelines from CMC, Clinical, NonClinical and Regulatory
-Team Lead for Polyclonal Blood-based T-cell Therapy for blood cancer (IOV-2001) - establishing Program Charter, objectives, and defining next steps for IOV-CLL-01

-Managed cross-functional pre-clinical stage program team for a first in class gene therapy for Rett Syndrome, a neurodevelopmental disease with an estimated 25,000 patients in U.S. and Europe and driving towards a potential multi-billion-dollar commercial opportunity with preliminary clinical data expected by year end 2022
-Program Lead for SLC13A5 deficiency. Facilitating strategy meetings expedite release of clinical biomarker data by year end 2022

Transformed corporate strategy into executable program plans relating to 6 CTA/IND regulatory submissions to enable a 2 first-in-human global clinical trials
Established and expanded PMO Toolkit to support the entire 20+ asset portfolio including timeline visualizations, dashboards, target product profiles and RAIDA logs utilizing automation in Smartsheet and Power BI. Mentored and empowered functional team members to utilize project management skills to utilize within their department

-Key member on the team responsible for NDA preparation and submission for Alport syndrome. Created NDA dashboard for increased transparency directly contributing to submitting NDA ahead of internal schedule by increasing schedule visibility and providing clear accountability
-Facilitated initiation of MAA submission planning and PIP development
-Assisted in building out new PMO structure and mentored and directly managed junior members on essential project management skills

-Responsible for process development and management of core business objectives including collaborating with multiple functions on NDA and Launch timelines
-Implemented new project management software and developed Tableau dashboards to track core deliverables including database lock, enrollment visualizations, and key project timelines

-Managed cross functional timelines for various clinical trials related to Bardoxolone Methyl and Omaveloxolone including Ph 3 Trials such as CARDINAL and MOXIe
-Created enrollment models to project future enrollment and analyze patient stratification in key geographic areas
-Facilitated company-wide integrated meetings for Clinical Trial Operations, Early Development, and submission readiness

-Managed clinical chemistry assay project plans within the various product development phases to optimize for blood and urine analysis. Progressed projects through stage gates to additional transparency to leadership teams
-Developed project deliverables with core members to ensure on time completion with a goal of 40% cost savings
-Responsible for obtaining technical updates for 20+ projects in the Feasibility and Concept stage to regional and global cross functional teams

-Managed Analytical lab within Process/QC group, responsible for the approval and release of 60+ raw materials and finished goods
-Designed and implemented new streamlined process for QC testing and reporting
-Utilized modern technology and ideas to improve lean lab processes and assisted in development of new products, reverse engineering, internal troubleshooting, writing reports/documentation/SOPs, and customer complaint investigation

-Project lead on hematology slide project involving optimizing blood smear slides. Launched 26 Tubed Cassette histology consumable products on time within 28 weeks to target estimated revenue of 250K
-Project lead for development of a new global Histology Consumable product that allowed access to an additional 35% of the market.
-Supported OEM projects, and initiated CAPA for a Germany-based blade mfg site. Designed experiments utilizing DOE. Wrote and performed test plans for V&V activities