- Title: Research Scientist
- Code: RCI-CON-0513
- Location: Somerset New Jersey (NJ) 08873
- Posted Date: 05/13/2019
- Status: Open
Talk to our Recruiter
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
Research Scientist (Somerset, NJ or various unanticipated locations in the US)
- Must have HPLC/GC-FID/GC-TCD/GC-MS/LC-MS/ICP-MS chromatography techniques with emphasis on stability indicating HPLC/GC methods.
- Manage activities at contract manufacturing & testing sites. Author regulatory documents for IND/NDA filing .
- Perform testing and data review for HPLC/UPLC achiral and chiral methods. Evaluate mass spectrometry data for impurity profiling. Maintain proper laboratory notebook and generate reports using EMPOWER and electronic documentation management system.
- Develop stability indicating HPLC/GC methods for assay/content uniformity and impurities identification to support synthetic drug substance and drug product manufacturing and release.
- Develop and implement HPLC, GC, LC-MS, FTIR and ICP-MS methods for in-process testing of raw material, intermediates and various metabolites for process development and optimization.
- Perform forced degradation studies; evaluate USP/ICH method validation parameters and critical quality attributes.
- Master’s degree in Biotechnology, Chemistry or a related field in Life Sciences and 2 years of experience or Bachelor’s degree with 5 years of progressive experience.
- Experience in water content by KF, small molecules analysis by GC-FID and GC-MS, TOC, osmolality, polarimetry testing for drug product. Experience in application of chromatography and mass spectrometry techniques toward impurity profiling.
Send resume to Rangam Consultants Inc. 270 Davidson Avenue, Suite #103, Somerset, NJ 08873. This position is eligible for the employee referral program.