Essential Responsibilities • Perform HPLC-MS/MS and NMR method development and validation supporting drug development • Conduct method development, structural characterization, impurity isolation and identification, and quantitative analysis • Perform routine HPLC, HPLC-MS/MS and NMR analysis • Coordinate the timely and compliant generation of data to support client projects • Participate in ongoing equipment maintenance and qualification • Review data for technical content and regulatory compliance • Interact with clients to design scientifically sound studies • Maintain current expertise with all appropriate ICH, GMP, and FDA guidelines
Requirements Educational Qualifications B.S. to Ph.D. in chemistry or related field with 5+ years analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience with good manufacturing practices (GMP) is required.
Specific Skills and Requirements • Experience with HPLC, HPLC-MS/MS, NMR, semi-prep chromatography, lyophilization, etc. • Experience with isolation and identification of impurities • Experience with GC-MS, FTIR, desirable, but not required • Experience with lab procedures (extraction, solid phase extraction, dilution, etc.)