Senior Large Molecule DS Product Steward
Core
Drive technical industrialization and sustain/improve the technical health of commercial large molecule drug substance products from manufacturability decisions through divestment.
Role type
Senior Large Molecule DS Product Steward
Builds
Commercial large molecule drug substance products
Domain
Pharmaceutical manufacturing (Large Molecule/Biological)
Required skills
Technical industrialization strategy, process performance qualification (PPQ), supply maturity optimization, technical risk mitigation, technology transfer, process validation, pharmaceutical quality systems, regulatory submission knowledge, patient-centric design
Preferred skills
PhD in scientific discipline, experience in platform specific process development or manufacturing operations
Technologies
None explicitly listed
Responsibilities
Develop technical strategic roadmaps for DS industrialization, investigate and mitigate technical risks across the commercial lifecycle, serve as primary product technical owner for site leadership and quality functions, represent the product in key technical governance forums
Seniority
Senior, hands-on IC