Analytical Chemist III
hace 11 días
Costa Mesa
Job Description 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.