Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
Using routine laboratory techniques, support drug substance/drug product formulation development through hands-on generation of accurate and precise analytical chemistry data
Techniques such as liquid chromatography (HPLC, UPLC), NMR (liquid), mass spectrometry, vibrational spectroscopy, gas chromatography, USP/EP dissolution testing, and/or Karl Fischer titration
Development and execution of studies to ascertain degradation mechanisms in the solution and solid state.
Development of assay/purity methods and assessment of method robustness/ruggedness
Development and execution of method validation protocols.
Development of dissolution methodology that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure.
Transfer of analytical methods to other laboratories and remote sites.
Hands-on generation of data in support of accelerated and registration stability studies.