Analytical Chemist III

POSITION SUMMARY

Under limited supervision, the Chemist III is responsible for performing routine analytical testing, supporting non-routine chemistry and development projects, method development/validation/transfer activities, preparing technical documentation, and maintaining laboratory equipment in the quality control analytical laboratory.

RESPONSIBILITIES

Perform routine laboratory testing (i.e., HPLC, LC/MS, UV-Vis, FTIR, CE, KF Titration, INSTRON, osmolality, pH, color/clarity, CCIT, particulate matter, wet chemistry) including finished product release, stability studies, and raw materials, following SOPs and GMP requirements. Author and execute protocols for method transfer, qualification, and validation. Support method development, non-routine projects, and analytical tech transfer/feasibility studies. Perform technical evaluation of complex analytical data. Create data summaries and author technical reports. Develop, author, and revise SOPs, as needed. Train and guide junior chemists. Assist with routine testing for WFI samples, including TOC, conductivity, and endotoxins, as needed. Perform QC peer-review of laboratory raw data. Calibrate, maintain, and troubleshoot various complex instruments such as HPLC, LC/MS, GC, UV/SoloVPE, etc. Initiate problem-solving for technical issues commensurate with level of experience. Assist with the implementation of new equipment, instruments, and software. Support quality system activities, such as deviation investigations and laboratory OOS/OOT investigations.

QUALIFICATIONS AND EXPERIENCE

Bachelor's or advanced degree in analytical chemistry, biochemistry, or a related field 7+ years (with Bachelor's) or 4+ years (with advanced degree) of analytical quality control experience in a cGMP setting, covering early and late-phase products. Strong knowledge of and hands-on experience with analytical techniques such as HPLC, GC, UV-Vis, mass spectrometry, and other common analytical equipment and techniques. Experience with method development, technical writing, and executing method validations/ method transfers.