Product Steward
Core
Own end-to-end process knowledge of drug substance manufacturing across the commercial lifecycle, acting as the single point of contact from technology transfer through commercialization.
Role type
Senior IC process steward (biopharma manufacturing)
Builds
Drug substance manufacturing processes and process control strategies
Domain
Biopharma / Upstream and downstream bioprocessing
Required skills
GMP manufacturing, upstream/downstream bioprocessing, statistical analysis, regulatory compliance (GMP/ICH), process validation, technology transfer, root cause investigation, CAPA implementation
Preferred skills
Computerized systems (SAP, Minitab, JMP), product registration strategies, lifecycle management
Technologies
SAP, Minitab, JMP, MS Office
Responsibilities
Maintain oversight of drug substance manufacturing process; Support development of process control strategy based on CQAs/CPPs/CMAs; Monitor critical process variables via statistical analysis and trending; Provide data for product transfer activities; Support troubleshooting and CAPA implementation; Support process validation planning and assessment; Contribute to regulatory submissions and site inspections
Seniority
Senior, hands-on IC
