MSAT Industrialization Leader, Drug Product Synthetics
Core
Ensures drug product processes developed in late-stage R&D are robust, scalable, and manufacturable at commercial scale, enabling successful transfer to manufacturing.
Role type
Senior IC process manufacturing and technology transfer leader
Builds
Commercial drug product supply chains and validated manufacturing processes
Domain
Biopharmaceuticals / Drug Product Synthetics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process Manufacturing, Manufacturing Process Improvements, Integrated Planning, Pharmaceutical Development, Process Optimization, Risk Management, Standards Compliance, Project Management, Strategy Development, Technology Transfer, GMP Compliance
Preferred skills
None stated
Technologies
None stated
Responsibilities
Define CMC development strategy for drug products, Lead manufacturability assessments and advise R&D on process design, Support Technology Transfer as RU and/or SU Process Leader, Contribute to and review CMC dossier sections, Serve as primary M&S representative in CMC development teams, Evaluate new technologies to enhance process robustness and efficiency
Seniority
Senior, hands-on IC