Aileen Mitchell Email & Phone Number

Whitehouse, NJ

• Discovery Support - Capabilities
• Routine non-GMP testing for elemental analysis (CHNO), trace metals (ICP-OES, ICP-MS, AA, GFAA), ion chromatography, residual solvents, UV, optical rotation, FT-IR, ect.
• Release testing of early phase materials using qualified methods for elemental analysis, trace metals, salt forming agents, residual solvents, ect. under cGMP conditions
• Quality Control testing of raw materials and active pharmaceutical ingredients tested using USP, EP and FCC monographs
• Develop and validate methods for Gas Chromatography, Ion Chromatography, HPLC and Karl Fisher for early phase clinical support

Served as analytical expert for drug substance and drug product on cross functional project teamDeveloped and validated HPLC assay and related substances, dissolution, content uniformity, and water determination methods for solid formulationsDeveloped and validated HPLC related substance, salt forming agent by HPLC, assay by titration, and water.

Performed registration stability testing for triple combination tablet assay and degradation product using Zymark TPWII robot Performed assay and degradation testing, content uniformity, water and dissolution testing for release and stabilityTrained analysts on use of Zymark TPWII robotWrote reportsDeveloped excel template to streamline entry of.

Performed HPLC assay and degradation products for stability and releasePerformed validations for drug product testing

Served as project lead for reference standard qualifications, method qualifications, method validations, release testing and routine ion chromatographySupervised and evaluated Associate Chemists and Chemists Coordinated multiple chemists' work for complete characterization of reference materials (ROI, residual solvents, purity by HPLC, Karl Fisher water.

Performed purity evaluations for reference standard qualificationsPerformed HPLC dissolution and ion chromatography testingWrote reportsDevelop Analytical Testing Procedures

Prepared solutions for testing (Sample, Standard, and Reagents)Performed HPLC AnalysisPerformed dissolution with UV analysis and HPLC analysis

Prepared solutions for testing (Sample, Standard, and Reagents)Performed HPLC AnalysisOrdered chemicals and lab suppliesPerformed Calibrations and Maintenance for HPLC equipment