ASU CMC Technical Integration Lead
Core
Drive integrated CMC technical execution and readiness for the COVID/Flu Annual Strain Update (ASU) by connecting Research, Technical Development, Manufacturing, Quality, Regulatory, Supply, and CMO inputs into a single decision-ready view.
Role type
Senior IC CMC Technical Integration Lead
Builds
Integrated CMC technical execution plan, readiness view, critical path, and governance-ready tradeoff summaries for ASU lifecycle.
Domain
Biopharmaceuticals / mRNA vaccines / CMC (Chemistry, Manufacturing, and Controls)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC technical judgment, matrix leadership, executive communication, documentation discipline, traceability mindset, technical-review rigor, continuous-improvement orientation
Preferred skills
Vaccine/sterile manufacturing CMC readiness, DS/DP interface understanding, regulatory-supporting data flows, cross-functional launch execution
Technologies
Automated CTD authoring tool
Responsibilities
Build and manage integrated CMC technical execution and readiness plan; Review and challenge technical readiness inputs to determine data/evidence sufficiency; Coordinate Module 3 handoff readiness and documentation traceability; Drive adoption of automated CTD authoring tool; Surface execution tradeoffs and escalation needs; Partner with Strategy/ALPS for governance alignment.
Seniority
Senior, hands-on IC
