Molecule Steward
Core
End-to-end technical accountability for a pharmaceutical product from bulk API manufacturing through formulation, packing, and lifecycle management, ensuring quality robustness and productivity improvements.
Role type
Senior IC molecule steward (pharmaceutical CMC strategy)
Builds
Pharmaceutical products (drug substance and drug product) for commercial supply
Domain
Biopharmaceutical manufacturing and supply chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC strategy, technology transfer, regulatory strategy (GMP, ICH Q7/Q8/Q9/Q10), product lifecycle management, process optimization, risk management, scientific writing, data integrity, lean management
Preferred skills
Project management, problem solving, stakeholder influence, CDMO management, cross-functional collaboration
Technologies
GxP regulations, digital fluency tools
Responsibilities
Define and maintain product control strategy, lead Product Technical Lifecycle Teams, coordinate regulatory submissions, manage investigations and critical deviations, ensure knowledge management alignment, collaborate with Supply Chain and R&D teams
Seniority
Senior, hands-on IC with strategic leadership
