Job Details

  • Title: Research Scientist
  • Code: RCI-CON-0513
  • Location: Somerset New Jersey (NJ) 08873
  • Posted Date: 05/13/2019
  • Duration:
  • Status: Open
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  Job Description

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.