Newark Metro Area, NJ
Responsible for analytical laboratory testing to support GMP manufacturing (kilo lab scale) and drug substance process development. The position will primarily focus on supporting drug substance manufacturing and will involve testing for material release, in-process samples and equipment cleanings/validation. The position will also work with process analytical project leads in method development and verification. The candidate is expected to perform laboratory analyses independently and may assist other analysts in analytical testing (chromatography, KF, spectroscopy and other analytical techniques). 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 drug substance manufacturing and development studies. Documents/reviews laboratory work using notebooks and worksheets that are detailed, timely and in compliance with cGMP requirements.
- BS/MS in analytical chemistry or relevant discipline with equivalent experience. Will consider zero to 10 years experience.
- Ideally their experience would be in cGMP pharmaceutical laboratory environment (but not necessary).
- Experience with HPLC, UPLC, GC, KF, FT-IR, UV/Vis spectrophotometry (FTIR, UV/VIS) and general wet chemistry.
- Experience with ICP-MS and an understanding of GMP manufacturing requirement and organic chemistry are is plusses.
- Good laboratory documentation skills. Strictly follows cGMP/GDP in reference to testing and documentation.
- Good communication skills. Able to work well in team environment to achieve results. Exhibits sound scientific judgment based on reasonable assumptions and available information.