Contract Manufacturing - Product Stewardship
Core
Technical steward for external-customer drug substance processes, ensuring robust manufacturing, lifecycle knowledge, and scientific interface between Novartis and CMO customers.
Role type
Senior IC technical product steward (biopharmaceutical manufacturing)
Builds
External-customer drug substance processes within the Novartis Contract Manufacturing network
Domain
Biopharmaceuticals / Contract Manufacturing
Required skills
Biopharmaceutical drug substance manufacturing, process development, MS&T, technical product stewardship, biotechnology processes (fermentation, downstream processing), GMP, regulatory aspects, statistical analysis, data handling, commercial awareness, risk management
Preferred skills
Experience in contract manufacturing environment, customer-facing technical role
Technologies
SAP, Minitab, MS Office
Responsibilities
Maintain end-to-end scientific ownership of external-customer drug substance processes; monitor process performance using statistical analysis and OPV; evaluate process changes for feasibility and regulatory impact; track product commitments and implement corrective actions; lead root cause investigations and cross-functional improvement initiatives; manage optimization projects; lead technology transfers of biological drug substances; represent Product Stewardship in governance meetings
Seniority
Senior, hands-on IC
