Recruited internally as an early member of a Gene Therapy Manufacturing Facility Startup Team, I was responsible for building out the site operational budget.
Liaising with FP&A, I led budget planning sessions, created and implemented a budget communication plan, led monthly budget reviews, initiated metrics reporting and monthly budget reviews.
I am proud the site's budgets were consistently approved in the first round of budget cycles and we achieved 100% financial compliance.
Gene therapy production planning is often unpredictable with changes in demand quantity and timing due to clinical demand.
Researching best practices and consulting key stakeholders, I developed a production planning process accounting for both new and changes to existing requests. I then solicited feedback from all stakeholders, made revision, executed the plan.
With a business process in place, we were able to significantly lower response times to demand changes and reduce our materials budget by 15%.
While facilitating a tech transfer of phase 3 clinical material to a contract manufacturer, the development team recommended a process change that increased yield by 15%.
Partnering with internal and external stakeholders, we delegated the work and meet weekly as a team to assess progress, predict and assess issues, and assign upcoming tasks.
While maintaining our clinical timeline, we successfully implemented the process change and limited production delays to one month.
Copyright © 2017 Jessica Slate von Goeler- All Rights Reserved.
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