Responsible for utilizing analytical methodologies, systems , and processes to support drug substance and drug product development throughout all phases.
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.
Support analytical method and technology transfer activities across laboratories and development sites.
Operate, maintain, calibrate, and troubleshoot analytical instrumentation under guidance.
Read and understand analytical methods, SOPs, compendial procedures, and GMP requirements while maintaining accurate documentation and data integrity within electronic laboratory systems.
Demonstrate strong ownership of quality, safety, productivity, organization, and client service expectations.