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.
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Job Type
Full-time
Career Level
Entry Level