The primary role of this position is to support the development, validation, implementation and trouble-shooting of analytical methods and the collection of data to set specifications applicable to new or existing generic pharmaceutical drug products.
BS degree with 5+ years of experience or Masters degree with 2+ years of experience or PhD in Chemistry (pref.), or other physical or biological science discipline will be considered.
Must demonstrate solid knowledge of the application of common analytical techniques. A working understanding of experimental design and the basics of statistical evaluation is expected.
Highly desired: Previous laboratory experience involving analytical method development using HPLC for cGMP use (e.g., pharmaceutical method analysis, quality control testing or bioanalytical method development - including development of methods, validation and/or transfer)
Desired: Good written and verbal communication skills. Forensic investigations, familiarity with manufacturing processes, statistical inference, physical testing methods (e.g., dissolution, rheology, or particle size). Familiarity with cGMP, GLP, FDA, ICH guidance.