Chemist II

RESPONSIBILITIES: Perform routine laboratory testing (i.e., HPLC, 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. Assist with routine testing for WFI samples, including TOC, conductivity, and endotoxins, as needed. With guidance, author and execute protocols for method transfer, qualification, and validation. Create data summaries and author technical reports. Develop and revise SOPs, as needed. Train and guide junior chemists. Perform QC peer-review of laboratory raw data for basic tests. Calibrate, maintain, and troubleshoot various basic analytical instruments, such as osmometers, pH/conductivity meters, balances, plate readers, etc. Calibrate, maintain, and troubleshoot various complex instruments such as HPLC, LC/MS, GC, UV/SoloVPE, etc., with guidance. 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 4+ years (with Bachelor’s) or 2+ years (with advanced degree) of analytical quality control experience in a cGMP setting, covering early and late-phase products. Hands-on experience with HPLC, UV-Vis, and other common analytical equipment and techniques. Experience executing method validations and method transfers. Proficiency with Microsoft Office and laboratory software for data collection and analysis. Experience with Chromeleon CDS is preferred. Knowledge of ICH, USP, Ph. Eur., and other regulatory and quality guidelines preferred. Effective communication skills, both written and verbal, for interaction with staff and vendors.