Understanding and experience with Standard Operating Procedures, current Good Manufacturing Practices (CGMPs), and other regulatory requirements are required.
This position requires experience with in-process analysis utilizing analytical instrumentation for UV Analysis, HPLC, and HPLC-MS.
The ability to support occasional weekend and evening work is required.
A Bachelor's degree (B.S.) in Chemistry or related life sciences field
0-2 years of relevant experience within the Industry
Exposure and knowledge of FDA regulations and guidelines
Knowledge of cGMP guidelines or international regulations (i.e., International Committee on Harmonization (ICH) Q7)
Knowledge of analytical equipment and instrumentation utilized for the testing of in-process samples.
Proficient with Microsoft Word and Excel