Chemist - Associate Scientist
Edison-New Brunswick Metro Area, NJ
Experience with HPLC, UPLC, dissolution, FT-IR, UV/Vis spectrophotometry, KF, etc. Good communication skills. Able to work well in team environment to achieve results
- Responsible for assisting with laboratory analysis for clinical release and clinical stability testing.
- Conduct reference standards qualification analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical testing for NDA submissions.
- Participate in validation, clinical testing and technical transfer analysis.
- Perform laboratory analysis under guidance of a supervisor or designee. Responsibilities will include, but are not limited to, the following: clinical release and stability testing, method validation support, reference standards qualification.
- Able to conduct testing independently and may assist other analysts in analytical testing including HPLC, UPLC, GC analysis, dissolution, Karl Fischer, UV/Vis and other analytical laboratory testing.
- Conducts routine analytical experiments using analytical methods and procedures such as finished products and API Assay, Related impurities and Dissolution testing.
- Good laboratory documentation skills. Strictly following cGMP in reference to testing and documentation requirements. Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with cGMP requirements.