Analytical Science and Technology Senior Scientist
Core
Develop, implement, and troubleshoot analytical methods for small-molecule drug products during late-stage development and commercial manufacturing.
Role type
Senior Scientist, Analytical Science and Technology
Builds
Analytical methods, validation protocols, and technical documentation for commercial pharmaceutical products
Domain
Pharmaceutical industry, small-molecule drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical chemistry, chromatographic methods (HPLC, Dissolution), compendial methods (KF, elemental impurity testing, spectroscopic identification), cGMP regulations, ICH guidelines, root cause analysis, data trending and visualization
Preferred skills
Method transfer to CMOs, process verification, continuous process improvement, project management
Technologies
HPLC, Dissolution testing, spectroscopic identification tools
Responsibilities
Design and perform complex analytical experiments; lead analytical method transfer to CMOs; support method validation for late-phase programs; prepare and approve technical documentation; oversee analytical service execution at external CMOs; analyze commercial data for process verification
Seniority
Senior, hands-on IC