Chemist I

Job Summary 

A Chemist I evaluate the chemical and physical properties of various raw materials and finished products under cGMP guidelines. Utilizes established methods and procedures and laboratory equipment to perform the analytical testing and ensure all products released are safe and efficacious.

Responsibilities

• Maintain a clean, organized, and safe work area.
• Perform daily calibrations and maintenance on analytical equipment, such as analytical balances, pH meters, density meters, etc.
• Prepare test solutions, compounds, or reagents for analysis of raw materials and finished products.
• Accurately and precisely perform analytical testing using a variety of wet chemistry techniques, such as weighing and measuring, density, specific gravity, pH, viscosity, titration, and conductivity.
• Perform assay, impurity/degradant, and solvent determinations by chromatographic analysis via thin-layer, gas (GC), high performance (HPLC), and ultra-performance chromatography (UPLC).
• Multitask projects while maintaining high levels of accuracy
• Other duties as assigned
• Provide honest and accurate support during analytical investigations of NCEs.
• Work in cross functional teams as necessary to complete projects, transfers, and investigations
• Maintain current training compliance on assigned SOPs and company policies.
• Accurately and legibly document and record all work completed so that analyses may be fully traceable and reproducible.
• Operate under all corporate safety requirements at all times, including use of PPEs and adherence to company policies in handling of hazardous substances

Qualifications

• Bachelor’s degree in Chemistry or Related Field
• Knowledge of FDA regulations
• Familiarity with Good Manufacturing Practices (GMPs)
• Familiarity with analytical laboratory operations and associated safety requirements
• Experience with chromatographic equipment and integration software
• Experience with Microsoft Office Suite of Products, including Word, Excel, and Teams
• Analytical laboratory experience
• Must be capable of wearing all appropriate PPEs correctly during handling of hazardous substances
• Some work may require extended periods of time standing at a lab bench
• Must be visually capable of accurately measuring and reading volumes of solution in volumetric apparatus (i.e. accurately read meniscus)