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.