Raw Materials Chemist

Job Summary

This position is primarily responsible for the laboratory testing of raw materials and packaging materials or in-process, release, and stability samples for commercial drug products.

• Perform accurate and timely analysis of raw materials and packaging materials or in-process, release and stability samples for drug products in accordance with current analytical procedures, SOPs, laboratory guidelines, and safety requirements.
• Test using basic lab equipment and procedures such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, and wet chemistry techniques such as titrations.
• Document all laboratory testing and maintain accurate, legible notebooks and records.
• Peer-review data, reports, and notebooks.
• Complete other projects and duties as assigned.

• BS degree in Chemistry or a related field.
• AS degree in Chemistry or a related field and a minimum of 2 years of pharmaceutical experience in a cGMP-regulated environment.
• BS degree in a non-science field and a minimum of 4 years of pharmaceutical experience in a cGMP-regulated environment.
• Knowledge of cGMP, USP/NF, and FDA guidelines and regulations.
• Experience in analytical methods and laboratory instrumentation (e.g., pH, ovens, titrations).
• Excellent oral and written communication skills.
• Strong organization and time-management skills.
• Demonstrated ability to work as part of a cross-functional team.
• Working knowledge of Microsoft Word and Excel.
• Experience with software associated with a Laboratory Information Management System (LIMS).

• Work mainly performed in the laboratory.
• Stand for extended periods of time in a laboratory setting.
• Wear personal protective equipment (PPE) as needed.
• Work with hazardous chemicals as needed to complete laboratory testing.