A Scientist I in the Analytical Chemistry department must have extensive experience in developing and validating analytical test methods for small molecule drug substances and drug products. Hands on experience with analytical tools used in the analysis of new chemical entities which includes: HPLC, LC/MS, GC, GC/MS, FT-IR, UV-Vis spectroscopy, dissolution, and Coulometric Titrator. Current knowledge in cGMP, GLP and ICH Guidelines required. Communicates experimental results and progress reports verbally and in written form. Reports to the Director of Analytical Chemistry.
Key Accountabilities/Core Job Responsibilities:
- Develop and validate analytical test methods for drug substances, drug products, raw materials and intermediates using HPLC and GC.
- Provide analytical support to medicinal chemistry, process chemistry, preclinical and formulation groups.
- Perform non-routine GMP and GLP analyses.
- Generate impurities of drug substances and drug products using forcing degradation conditions, isolate impurities using solid phase extraction and/or preparative HPLC; and characterize impurities.
- Participate in the Out of Specification (OOS) or Out Of Trend (OOT) investigations.
- Write SOPs, test methods, method development and analytical reports.
- Trouble-shoot, calibrate and maintain instruments in working condition for HPLC, GC and GC/MS.
Education and Training: (degree, certifications, etc.)
- B.S or M.S. in Chemistry or Biochemistry required.
- Ph.D. in Chemistry or Biochemistry preferred.
- Documented training in cGMP and GLP regulations.
- 0-2 years of experience in analytical chemistry in the pharmaceutical industry with a Ph.D degree, or 10+ years with a M.S. or B.S degree.
- May have experience in directly managing junior analysts.
- Strong in analytical chemistry using HPLC, GC, GC/MS, LC/MS, NMR, FT-IR, Karl Fisher, UV-Vis Spectroscopy and Preparative HPLC.
- Good organization skills for designing experiments and producing high quality work.
- Involved in method development and method validation using HPLC and GC. Familiar with GMP and GLP.