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.
Responsibilities
- 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.
Education
- Bachelor’s degree in Chemistry or Biology is preferred.
- Degrees in Engineering will be considered if applicable to laboratory operations.
Experience
- Regulatory Knowledge: Demonstrated understanding of cGMP principles and regulatory requirements.
- Laboratory Proficiency: Hands-on experience with foundational equipment (Karl Fisher, pH/conductivity meters) is required; experience with HPLC, dissolution apparatus, FTIR, or NIR is highly preferred.
- Process Improvement: Knowledge of continuous improvement, 5S principles, and the Tier process.
- Technical Skills: Experience with Empower chromatography data software and Labware LIMS is preferred.
- Analytical Writing: Background in technical writing for SOPs and experience participating in investigation meetings.
