Responsibilities:
- Perform dissolution, assay, and impurity tests on API and finished products.
- Evaluate and validate analytical methods following GMP and FDA requirements.
Job Requirements:
- Bachelor’s degree/equivalent in chemistry, chemical engineering, pharmaceutical manufacturing engineering, or related.
- Familiar with cGMP/GLP regulations, FDA requirements for pharmaceutical API and finished products, and USP tests for various pharmaceutical products.
- Proficiency in HPLC, UPLC, GPC, IC, and quantitative assays following FDA regulations.