Principal Associate Scientist, Analytical Sciences
Core
Perform analytical testing of siRNA drug substances, drug products, and critical raw materials; design and execute special use stability studies; contribute to regulatory submissions and investigations.
Role type
Senior IC analytical scientist (stability & characterization)
Builds
siRNA drug substances and products
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC/UPLC/US spectroscopy/pH analytical techniques, stability study design (ICH guidelines), statistical analysis, technical writing, change controls, CAPA, GMP/GxP compliance
Preferred skills
DoE principles, freeze-thaw/thermal cycling study design, regulatory agency response support
Technologies
HPLC, UPLC, US spectroscopy, pH meters
Responsibilities
Perform analytical testing of siRNA drug substances and products; Author and review stability protocols, reports, and SOPs; Design and execute special use stability studies; Contribute data to regulatory submissions; Investigate stability Out of Trend (OOT) results
Seniority
Senior, hands-on IC
