Iowa City, IA
The Scientist I will provide analytical support for multiple project teams. This individual will collect and analyze data to support the development, validation and transfer of analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.
- Safely and effectively collect analytical data to help develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
- Perform analytical chemistry assays based on new and existing methodologies
- Operate analytical instrumentation such as HPLC, GC, GC/MS, LC/MS, FTIR, Titrator, Particle Size Analyzer
- Maintain laboratory notebooks documenting work
- Maintain compliance with GMP SOPs and DEA regulations
- Transfer documented analytical methods to the QC and Process Support Group departments
- Set up new or existing analytical methods for compound identification, purity and potency testing.
- Coordinate off-site testing as necessary
- Conduct testing of analytical samples for the Chemical Development Department as needed.
- Collect analytical data to help qualify reference materials.
- May also perform other duties as required
- M.S. in Chemistry or related field or B.S. degree in Chemistry or related field with 4 years of experience in lab environment, pharmaceutical experience preferred.