Michelle Ye Email & Phone Number

Greater San Diego Area

I, Analytical and Formulations Development 2009-2010Carried out long term and short term non-GMP stability studies of in process samples and final drug product materials.Determined optimal formulations for in process samples and final drug product materials.Determined optimal reaction conditions for PEGylation of proteins.Supported molecular technology, process science, and process development teams by performing sample characterization/quantitation using HPLC, LC-MS, and plate based assay methods.Developed size exclusion, reversed phase, and cation exchange HPLC methods to support various teams and project needs.Assisted in qualification and validation of HPLC methods.Improved efficiency of the sample support process for antibody drug conjugate projects by utilizing additional built-in functions of Agilent Chemstation.Maintained cross-functional communication regarding sample support between teams in the company as well as collaborators and contract manufacture companies.Wrote development, stability and qualification reports as pertains to each study or developed method of analysis.Assisted in materials tracking and distribution.Preparation/development of mobile phases and columns for HPLC analysis. Maintained detailed records of experiments in laboratory notebooks.Preparation and presentation of data in company staff meetings.

Maintained detailed records of conjugated monoclonal antibodies in a computerized database as well as original document binders.Analyzed quality of conjugation and purification process for each lot of fluorescent tagged monoclonal antibodies by IEF gels.Preparation and casting of IEF gels.Assisted in revision of conjugation protocols for each fluorescent tag.Assisted in re-organization of original documentation of conjugated monoclonal antibody products.Participated in 6-month and end of year inventory control.Prepared necessary buffers for conjugation process.Monitored quality of sizing columns (washing, repacking, etc.).

Inoculation of multiple bacterial cultures submitted by clients on Biomek FX liquid handler.DNA extraction from bacterial cultures through use of magnetic beads on Biomek FX.Preparation and analysis of samples by PCR.DNA sequencing on Applied Biosystems gene analyzer 3100.Utilized Cherry-picking to help in clone selection for E. coli library.Various microarray computer analysis.Preparation of LB plates with antibiotic selection using sterile techniques.Preparation of buffers, lab chemicals.General lab up-keeping, and filing of documents.

Bachelor Of Science, Biochemistry, Biotechnology & Molecular Biology

Bachelor Of Science 2007, Biochemistry/Biotechnology & Molecular Biology