Ability to work in a GLP or GMP environment with appropriate documentation and safety practice.
Independently develop, utilize, and validate test methods containing advanced analytical techniques such as liquid chromatography (HPLC, UPLC), USP/EP dissolution testing, mass spectrometry, vibrational spectroscopy, gas chromatography, and/or Karl Fischer titration to characterize drug products, APIs, intermediates, and impurities in support of formulation.
Develop dissolution methodologies that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure.
Develop and execute studies to ascertain degradation mechanisms in a variety of environmental, formulation, and stress conditions.
Assess stability risks by evaluating process changes and impact on degradation chemistry or dissolution profile. This would involve DoEs and accelerated stability studies.
Develop assay/purity methods and assessment of method robustness/ruggedness
Develop and execute method validation protocols.
Transfer analytical methods to other laboratories and remote sites.
Hands-on generation of data in support of accelerated and registration stability studies.
Mentor junior chemists by guiding analytical best practices, experimental design, and data interpretation.