Newark Metro Area, New Jersey
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. Responsibilities will include, but are not limited to, the following: 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.
The successful candidate will be 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. 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, 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.
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.
Good communication skills.
Able to work well in team environment to achieve results.
Exhibits sound scientific judgment based on reasonable assumptions and available information