Job Summary We are seeking a highly motivated and detail-oriented Chemist to join our team on the 3rd shift in a dynamic pharmaceutical laboratory environment. In this role, you will be responsible for conducting complex analytical testing, supporting quality control processes, and ensuring compliance with regulatory standards. Your expertise in laboratory techniques and instrumentation will contribute to the development, validation, and maintenance of analytical methods that uphold our commitment to product quality and safety. This position offers an exciting opportunity to work within a fast-paced, innovative setting dedicated to advancing pharmaceutical research and manufacturing. Responsibilities Perform routine and non-routine analytical testing using techniques such as spectroscopy (including FTIR, UV-Vis, and spectrophotometry), chromatography (HPLC, GC, LC-MS, GC-MS), and microbiological assays in accordance with GLP (Good Laboratory Practice) and CGMP (Current Good Manufacturing Practice) standards. Prepare samples accurately through sample preparation procedures, ensuring proper handling and documentation in Laboratory Information Management Systems (LIMS). Calibrate and maintain laboratory instruments including spectrophotometers, chromatographs, mass spectrometers, microscopes, and other laboratory equipment to ensure optimal performance. Conduct method validation activities following ICH guidelines to confirm analytical procedures are reliable, reproducible, and compliant with FDA regulations. Support laboratory compliance by adhering to strict safety protocols, maintaining accurate records of experiments, calibrations, and maintenance logs. Assist in troubleshooting instrumentation issues and perform routine equipment maintenance to minimize downtime. Collaborate with cross-functional teams on project work involving biochemical techniques, microbiology testing, and biochemistry assays to support product development and quality assurance efforts. Skills Extensive knowledge of
GLP, CGMP, GMP
regulations, and pharmaceutical regulatory compliance standards. Proficiency in wet chemistry techniques including sample preparation, titrations, pH measurements, and chemical analyses. Strong experience with spectroscopic analysis methods such as FTIR spectroscopy and spectrophotometry. Expertise in chromatography techniques including high-performance liquid chromatography (HPLC), gas chromatography (GC), liquid chromatography-mass spectrometry (LC-MS), and gas chromatography-mass spectrometry (GC-MS). Skilled in using laboratory instruments such as spectrophotometers, microscopes, Fourier-transform infrared (FTIR) spectroscopy devices, mass spectrometers, and chromatographs. Familiarity with laboratory information management systems (LIMS) for data recording and reporting. Ability to perform method validation according to ICH guidelines for analytical procedures. Experience with microbiological testing methods and biochemical laboratory techniques. Strong attention to detail with excellent recordkeeping skills; capable of maintaining high standards of laboratory accuracy and compliance. Knowledge of FDA regulations related to pharmaceutical laboratories; understanding of sample preparation protocols for complex analyses.
Pay:
$60,000.00 - $70,000.00 per year
Benefits:
401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance