- Groton, Connecticut, United States
- Full-time
- 2–4 years
Responsible for utilizing analytical methodologies, systems, and processes to support drug substance and drug product development throughout all phases.
Responsibilities
- Prepare, set up, and analyze drug substances and/or drug product samples using a variety of analytical techniques including chromatography (e.g., HPLC, UPLC, LCMS GC, GCMS, SFC), spectroscopy (e.g., UV-Vis, NMR), dissolution, and other relevant methodologies (e.g., KF, pH, ROI).
- Support development and optimization of analytical methods, including assay, purity, dissolution, and/or impurity characterization approaches as appropriate.
- Execute method qualification, validation, and transfer activities to support development and commercialization programs.
- Conduct degradation, stability, and investigational studies to support the evaluation of product performance and risk.
- Assess stability, dissolution, and/or impurity trends to support product and process development decisions.
Requirements
- Bachelor’s degree in chemistry, biochemistry, or other related degree concentration
- Masters or Engineers with 0-2 years of related experience