VP, Late-Stage & Commercial Biologics Development
Core
Lead the CMC strategy and MSAT function for late-stage antibody-based biologics, transitioning clinical manufacturing to commercial readiness.
Role type
VP, Late-Stage & Commercial Biologics Development
Builds
Commercially viable manufacturing processes for high-impact antibody therapeutics and combination products
Domain
Biopharmaceuticals / Antibody-based biologics / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mammalian cell culture, antibody therapeutics development, process characterization, PPQ studies, QbD principles, DoE statistical modeling, regulatory submissions (BLA/MAA), tech transfers, CDMO management, combination product design controls, device integration
Preferred skills
leadership of high-performing technical teams, cross-functional collaboration, global health authority navigation (FDA/EMA)
Technologies
upstream cell culture, downstream purification, pre-filled syringes, autoinjectors
Responsibilities
Spearhead late-stage process development strategy for upstream/downstream operations; Oversee process characterization and PPQ studies; Champion CMC sections for global regulatory submissions; Steer technical process transfers and scale-ups; Develop and mentor a high-performing team; Navigate interactions with global health authorities; Partner with QA, Regulatory, Supply Chain, and Commercial teams
Seniority
VP, strategic leadership & hands-on technical direction