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 determination by Karl Fisher for drug substanceDeveloped and validated automated sample preparation methods on Zymark TPWII robotCoordinated release testing for drug substance and drug product to support clinical studiesCertified to performed enhanced review of release testing for drug products for clinical studies (Further QA review is not required)Performed department wide training for FMEA risk analysis and Drug substance reference standard characterization Facilitated FMEA risk analysis for analytical methods with experts from research, development and technical operationsEvaluated S-Matrix Fusion method development and validation softwareWrote method validation and stability reports for drug substance and drug product to support new formulation IND and NDA filingAdministered external reference standards for departmentReviewed release packages for post packaging analysis

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 dissolution profile data into LIMS data management systemAdministered external reference standards for departmentPerformed release testing for post packaging analysis

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 determination, Counter-ions, FT-IR, Outsource work for NMR, LC-MS) Performed HPLC, dissolution, ion chromatography, and gas chromatography testingDeveloped pricing estimators and project plans for routine analyses, method development/feasibility, method qualification and method validationsChemist I Feb. 2003 - Feb. 2004Trained Associate Chemists and Lab Technicians for HPLC and ion chromatographyPerformed HPLC, dissolution and ion chromatography testingWrote reportsDeveloped project plansDeveloped templates for routine analysis

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