Associate Scientist - Chemistry
Edison-New Brunswick Metro Area, New Jersey
BS/MS in analytical chemistry or relevant discipline with equivalent experience.
Minimum 2 - 4 years recent cGMP pharmaceutical laboratory experience.
Experience with HPLC, UPLC, dissolution, FT-IR, UV/Vis spectrophotometry, KF, etc.
Responsible for conducting and assisting with laboratory analysis for clinical supplies release and clinical supplies stability testing.
- Conduct reference standards qualification analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical supplies testing for IND/IMPD/NDA submissions.
- Participate and conduct validation analysis, clinical supplies testing and technical/methods transfer analysis all under GMP protocol driven processes.
- Perform laboratory analysis and GMP testing under guidance of a supervisor or designee.
- Clinical supplies release and stability testing for drug substance (API) and final formulated drug product, method validation analysis and support testing, reference standards qualification and analysis.
- Able to conduct analytical experimental and/or GMP testing independently and may assist other analysts in analytical testing using analytical techniques and instrumentation including HPLC, UPLC, GC analysis, dissolution, Karl Fischer, UV/Vis and other (compendial) analytical laboratory testing.
- Conducts routine analytical experiments and GMP analyses using defined analytical methods and procedures such as finished products and API Assay, Related impurities and Dissolution testing.
- Will also participate in feasibility and experimental method development designed to optimize and define analytical methods for further validation.
- Performs instrument/method troubleshooting within analytical method parameters and management guidance (If needed for confirmatory or investigational testing).
- Performs testing for development, clinical supplies release and stability samples in accordance with established methods, specifications and protocols under GMP with limited supervision.
- Good laboratory documentation skills.
- Strictly follows GMP testing and documentation requirements.
- Documents/reviews laboratory work using laboratory notebooks/worksheets, ELN, LIMS and instrument electronic databases and integration programs that is detailed, timely and in compliance with GMP requirements.