Senior Large Molecule DS Product Steward
Core
Drive technical industrialization and sustain/improve technical health of commercial large molecule drug substances from manufacturability decisions through PPQ, supply maturity, optimization, and divestment.
Role type
Senior Large Molecule Drug Substance Product Steward
Builds
Commercial large molecule drug substance products
Domain
Pharmaceutical manufacturing (Large Molecule/Biologicals)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug Substance manufacturing expertise, Process development for biological molecules, Technology transfer, Process validation, Pharmaceutical quality systems knowledge, Regulatory submission understanding
Preferred skills
PhD in scientific discipline, Experience in platform-specific manufacturing operations
Responsibilities
Develop technical strategic roadmaps for DS industrialization, Investigate and mitigate technical risks across commercial lifecycle, Serve as primary product technical owner for site leadership and quality functions, Represent product in key technical governance forums
Seniority
Senior, hands-on IC
