Xiaoling Lu Email & Phone Number

Winston-Salem, Nc

• Created critical methods for chiral separations and purifications that enabled an increased number of compounds advancing into late stage development.• Developed preparative LC-MS and GC methods for separation of non-chromophore containing compounds which was essential to the success of high priority projects.• Led efforts to evaluate chemical stability of compounds, which decreased risk of late stage failures.• Supported medicinal chemistry group in determination of chiral purity for final compounds.• Provided analytical support to process research chemistry group to evaluate optimized reaction procedures and to streamline processes. • Maintained, troubleshot, and operated walk-up LC-MS systems for medicinal chemistry group.• Executed method transfers to contract research laboratories.• Performed analyses associated with data generation for Food and Drug Administration (FDA) regulatory filings and clinical studies.

Winston-Salem, Nc

• Analytical Chemistry, Extended chromatography skills to chiral separations of racemic compounds, which filled an unmet need of the organization.• Performed qualitative and quantitative analyses for purity, solubility and stability studies of NCE’s.• Trained in the operation of gas chromatography-mass spectrometry (GC-MS), differential scanning calorimetry (DSC), and thermal gravimetric analysis (TGA).

High Point, Nc

• Performed cGMP analyses of raw materials and finished goods• Method transfer and validation for new products• Documentation, data collection, and summary report preparation• Stability testing for assay, Impurity, degradation, and physical properties • Method trouble-shooting for USP and Internal methods and SOP’s. • Instrument trouble-shooting (HPLC, GC, FTIR, Karl Fischer and UV)• Performed OOS (out of specification) investigations to GMP and company regulations.

Associates Of Science-Chemistry, Analytical Chemistry Science, 3.5

Bachelor Of Applied Science (B.A.Sc.), Engineering Science