VP, Late-Stage & Commercial Biologics Development
Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.
We are looking for a creative, experienced and highly technical leader to shape the CMC strategy of our late-stage development programs through to commercialization. This is a rare opportunity to build and lead a late-stage Manufacturing Science and Technology (MSAT) function for high-impact antibody-based biologics. You will transition our lead asset from clinical manufacturing into a robust, commercially viable process and manage our late-stage CMC portfolio of combination products as our pipeline progresses through development.
How you might spend your days
- Spearheading the overall late-stage process development strategy for upstream cell culture and downstream purification, starting with our lead antibody program and ensuring a seamless transition from Phase 2/3 clinical manufacturing to commercial readiness
- Overseeing the process characterization and PPQ studies and establishing robust control strategies and proven acceptable ranges (NORs/PARs) based on QbD principles and DoE statistical modeling
- Championing the drafting and review of relevant CMC sections for glo
