Newark Metro Area, New Jersey
- 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.
- Draws basic conclusions from data and results and communicates with other analysts and management.
- Performs instrument/method troubleshooting within analytical method parameters and management guidance (If needed for confirmatory or investigational testing).
- Performs testing for development, release and stability samples in accordance with established methods, specifications and protocols with limited supervision.
- Good laboratory documentation skills.
- trictly 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.
Minimum 2 - 4 years recent cGMP pharmaceutical laboratory experience.
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.
Exhibits sound scientific judgment based on reasonable assumptions and available information.
BS/MS in analytical chemistry or relevant discipline with equivalent experience.