Day-to-Day Responsibilities
Develop new test methods for drug substances and finished products using techniques such as HPLC, GC and UV-Vis spectroscopy.
Validate methods against ICH and pharmacopoeia requirements, covering accuracy, precision, linearity, range and robustness.
Run stability studies to show how a product holds up over time and under heat and humidity.
Investigate out-of-specification results and troubleshoot instrument or method problems.
Transfer validated methods to quality control (QC) labs and train analysts who will run them.
Write protocols, validation reports and technical documents, and support regulatory filings and inspections.


