Executive Director, Chemical Process R&D
Core
Owns Drug Substance (DS) process strategy and execution oversight to enable scalable, safe, and cost-effective external manufacturing for MASH therapeutics.
Role type
Executive Director, Chemical Process R&D
Builds
Scalable manufacturing processes and tech transfer packages for CDMOs
Domain
Biopharmaceuticals / Chemical Process R&D
Required skills
Process chemistry leadership, Route development, RSM strategy, Impurity strategy, Tech transfer management, CDMO governance, Process controls, CMC documentation, Cross-functional leadership
Preferred skills
Phase 2 progression support, Polymorph/solid-form implications
Technologies
N/A
Responsibilities
Define DS route and RSM strategy aligned with phase-appropriate control strategy; Approve process R&D plans (optimization, robustness, impurity investigations); Lead DS tech transfer expectations and readiness criteria for CDMOs; Partner with Analytical and Engineering on method readiness, scale-up, and safety; Provide DS inputs and rationales for CMC documents and health authority responses.
Seniority
Executive Director, strategic leadership & hands-on oversight
