Analytical Development Principal Scientist
Core
Develop control strategies for novel small molecule drug substances, overseeing analytical activities from clinical to commercial phases.
Role type
Principal Scientist, Analytical Development (Small Molecule)
Builds
Drug substance process and control strategies for clinical and commercial phases
Domain
Pharmaceutical manufacturing, small molecule drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Control strategy development, QbD principles, cGMP/ICH/FDA/USP guidelines, chromatography, synthetic organic chemistry understanding, regulatory submission documentation
Preferred skills
Spike/purge studies, toxicology study support, solid-state development, contract manufacturing lab management
Technologies
Chromatography systems, in silico control tools (ICH M7)
Responsibilities
Design and oversee drug substance process development analytical activities; set and justify drug substance specifications; identify critical in-process-control issues; develop analytical methods for progressive development stages; justify retest periods and storage conditions; document critical factors impacting quality; develop source documents for regulatory submissions
Seniority
Principal, hands-on IC with strategic oversight
