Principal Scientist, Process Chemistry
Core
Lead drug substance activities for small molecule products from clinical phase testing through commercial supply, designing processes and leading demonstrations from lab to pilot plant.
Role type
Principal Scientist, Process Chemistry (Small Molecule)
Builds
Drug substance processes and data packages for clinical and commercial regulatory submissions
Domain
Biopharmaceuticals / Small molecule drug development
Required skills
Organic Chemistry, Pharmaceutical Sciences, CMC development, GMP requirements, CRO/CDMO management, salt/crystalline form selection, continuous processing, catalysis, biocatalysis, high throughput experimentation
Preferred skills
Oligonucleotide chemistry
Technologies
Lab equipment, pilot plant systems, CRO/CDMO platforms
Responsibilities
Design early and late-phase drug substance processes; lead lab-to-pilot plant demonstrations; identify final API forms; collaborate with CMC teams; manage external CRO/CDMO partners; author regulatory submissions; define manufacturing strategy and GMP execution; manage quarterly budgets; contribute to intellectual property.
Seniority
Principal, hands-on IC with strategic leadership