Executive Director, Chemical Engineering Lead
Core
Leads chemical engineering strategy and execution to ensure drug substance/drug product (DS/DP) processes are scalable, safe, and transferable to external manufacturing for MASH therapeutics.
Role type
Senior IC chemical engineering lead (strategy & execution)
Builds
Scalable, safe, and transferable manufacturing processes for novel therapeutics
Domain
Biopharmaceuticals / Chemical Engineering / GMP Manufacturing
Required skills
Scale-up engineering, process safety, manufacturability assessments, tech transfer readiness, validation strategy, cross-functional influence, structured problem solving
Preferred skills
SDD process scale-up, solvent/safety considerations, validation/PPQ readiness
Technologies
GMP manufacturing systems, process safety tools
Responsibilities
Set engineering standards for scale-up readiness, safety, and process/equipment fit; Support DS/DP teams in defining scalable process parameters; Lead engineering input to tech transfer, process safety reviews, and risk assessments; Drive yield/throughput/cycle-time improvement opportunities with external partners; Ensure engineering documentation supports validation readiness and audit expectations
Seniority
Senior, hands-on IC with strategic oversight