Perform authoring/verifying/reviewing upstream sections of CMC regulatory submissions for clinical trial and marketing applications. Act as SME for responses to Health Authorities questions involving animal-derived materials and adventitious agent safety testing and characterization of production cell banks, virus seeds, and unprocessed bulks. Responsible for authoring TSE-BSE risk assessments for cell banks and animal-derived raw materials used in upstream activities. Support in-licensed projects by reviewing documentation for compliance and perform gap assessments. Provide lifecycle management technical guidance and support for post-approval cell culture and raw material investigations and regulatory submissions. Retirement date is 15Dec2023.

Currently involved in scientific and regulatory writing of development reports, INDs, and BLAs as well as risk assessments for and safety testing of cell banks. Developed protocols for Cell Therapy team for use in CAR-T projects. Created protocols for CHO cell cloning and single cell verification of clonality using 384-well plates, FACS, and plate imaging. Investigated cell product aggregation for difficult-to-express proteins. Developed transfection and selection protocols for FUT-8 knockout cell line and other CHO cell lines. Lead media development efforts for low-density cell growth of CHO cells. Developed protocols for freezing and thawing CHO cells in a 96-well plate format.

Team lead for CHO cell cloning and single cell verification of clonality using 384-well plates, FACS, and plate imaging project. Lead media development efforts for low-density cell growth of a variety of CHO-derived cells. Lead technology development efforts in optimizing protocols for a FUT-8 knockout cell line development process. Developed protocols for freezing and thawing CHO cells in a 96-well plate format. Provided support in transfection, selection, and cloning to Cell Line Development team.

Member of Cell Line Engineering Group in R&D. Generated stable mammalian cell lines for production of biopharmaceuticals by transfection and electroporation. Optimized protocols for cell line generation in multiple host lines using the GS system. Created high-titer, stable cell lines in CHO and NS0 lines for production. Evaluated stability of clones using intracellular staining and flow cytometry.

Member of Lead Discovery Target Team. Responsible for RNAi transfections, analysis, and small molecule RNAi-mimic-based screen using microarray and qPCR. Focal member of RNAi Team as part of Avalon’s target discovery efforts. Developed assays for evaluating RNAi transfection/electroporation efficiency and monitoring non-specific effects. Assisted in creating a beta catenin intangible-target screen using genes affected by RNAi silencing of beta catenin in colon cancer cells.Developed and evaluated proliferation assays as part of secondary screening platform. Developed BrdU, ATP, mitochondrial potential, live/dead, tubulin polymerization, soft agar, and cell adhesion assays in-house. Assisted in data mining efforts using software from Gene Logic and Compugen. Assisted in microarray data analysis. Performed 3D cell culture experiments using various methods including the rotary cell culture system from Synthecon (RCCS).

Worked under Life Technologies, Inc.

Member of the cationic lipid transfection team in R&D Gene Expression Group producing pGreenLantern, LipofectAMINE PLUS, LipofectAMINE 2000, OligofectAMINE. Responsible for quality control development and stability studies for state of the art products.Instrumental in product development and release of successful new transfection products. Wrote product quality control documents and spreadsheets for use in manufacturing. Assisted in training and transfer of QC from R&D to manufacturing.Developed fluorescent and luminescent assays to monitor gene expression. Developed automated data analysis worksheets using Excel macros.