Senior Scientist, Analytical Research & Development
Core
Develop, validate, and execute instrumental test methods for drug substances and products, ensuring data integrity and compliance with regulatory standards.
Role type
Senior Scientist, Analytical Research & Development
Builds
Analytical test methods, raw material evaluations, and testing of non-commercial materials for softgel development and manufacturing.
Domain
Pharmaceutical manufacturing (CDMO), Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC, UPLC, GC, MS, NMR, method development, method validation, root cause analysis, SOP writing, data integrity management, hazardous waste disposal
Preferred skills
None stated
Technologies
HPLC, UPLC, GC, MS, NMR
Responsibilities
Independently develop and validate instrumental test methods; analyze data and document results per cGMP; serve as lead scientist for client-facing projects; perform analysis of finished products, in-process materials, and raw materials; write and review analytical methods, protocols, and specifications; ensure right-first-time execution of departmental methods and audit results; safely handle potent and teratogenic compounds.
Seniority
Senior, hands-on IC
