Chemist

We are looking for a detail-oriented Chemist to join our team in a fast-paced GMP laboratory environment. This role is primarily responsible for conducting routine analytical testing—including dissolution, assay/degradate, and identity testing—to ensure the highest quality of our products. Beyond bench work, you will be a key player in our continuous improvement culture, participating in root cause analysis, instrumentation troubleshooting, and daily Tier processes to drive operational excellence.

• Perform routine laboratory testing including dissolution, assay/degradate, content uniformity, and identity testing.
• Maintain meticulous documentation of all results within a strictly regulated GMP laboratory environment.
• Operate and maintain essential lab equipment such as Karl Fisher, pH meters, conductivity meters, and UV/Vis spectrometers.
• Utilize Empower and Labware/LIMS systems for data entry, management, and analysis.
• Assist in the drafting and execution of quality notifications and laboratory investigations.
• Participate actively in daily Tier meetings to coordinate tasks and report on laboratory metrics.
• Execute root cause analysis for simple instrumentation issues and laboratory deviations.
• Drive workplace organization and efficiency by applying 5S principles and continuous improvement methodologies.
• Update and maintain Standard Operating Procedures (SOPs) through technical writing.

• Bachelor’s degree in Chemistry or Biology is preferred.
• Degrees in Engineering will be considered if applicable to laboratory operations.

• Experience operating laboratory equipment: HPLC, dissolution apparatus, FTIR, NIR, etc.
• Experience utilizing Empower.
• Experience utilizing Labware/LIMS.
• Knowledge of regulatory and cGMP principles.
• Experience performing peer review of GMP Analytical Laboratory Data
• Background in technical writing including but not limited to: updating of standard operating procedures and writing quality notifications.
• Knowledge of Tier processes.
• Experience executing 5S principals.
• Understanding of root cause analysis principals.