Glenn Deaver Email & Phone Number

Lake Forest,Il

Subject matter expert in all areas of bioassay development with focus on immunogenicity and product safety.• Isolation, depletion, and differentiation of cell types from PBMC populations for immunogenicity testing.• PBMC proliferation assay development and immunogenicity testing of drug products and product impurities to establish product safety.• Development of assay to measure risk of adverse drug reactions using KU812F cells and B-hexosaminidase that enabled the risk assessment of drug candidates.• Preparation, performance assessment, and mycoplasma testing of cell banks for use in bioassays and product pipeline support.• Performed monocyte activation testing to detect pyrogenic potential of drug product impurities that helped to ensure product safety.• Used lentiviral transduction to overexpress the ACTH receptor in h-adrenal carcinoma cells to improve the magnitude and sensitivity of the cAMP response.• Successfully completed training and transfer of complex bioassay to CRO to meet project requirements.

Lake Forest, Illinois, United States

Research and development of bioassays and immunoassays to support biosimilar pipeline including growth factors and therapeutic monoclonals (mAbs). • Led development and qualification of a process specific host cell protein (HCP) assay. Trained analysts and supported validation in Adelaide, Australia.• Developed and qualified cell-based methods for measuring potency of mAbs using ECL, HTRF and enzyme fragment complementation technologies.• Miniaturized assays and introduced practices to improve consistency and reduce costs.• Successful training, transfer, and validation of a cell-based proliferation using “thaw and use” cells to commercial QC site in Zagreb, Croatia.• Recruited and mentored graduate students from Northwestern University in the performance of analytical methods to help support biosimilar characterization.

Greenfield, In

Perform assay development and method validation according to ICH and USP guidelines. Write methods, protocols and reports. Participate in client conferences and manage activities to meet project timelines. Critically evaluate data and communicate results in reports and presentations. Conduct laboratory investigations and initiate deviations, CAPA, and change control quality events. Perform variety of bioassays (cell proliferation, inhibition, reporter gene activity, receptor phosphorylation, toxin neutralization, cAMP production, compound uptake, ADCC, CDC, efflux) using a wide range of detection technologies.

Greenfield, In

Technical expert in the performance of cell based assays responsible for GMP and non-GMP analysis of client test samples in QC environment. Review data packages. Write SOPs and Test Summary Reports, and prepare Certificates of Analysis. Provide strong hands on support for laboratory operations by providing technical leadership and mentoring of staff.

Emeryville, Ca

Contract employee responsible for the CPE bioassay characterization of IFN-β/HSA complexes in SEC fractions of Betaseron drug product for FDA 483 observation response. Developed testing plan and supervised team of three analysts performing the CPE bioassay characterization in high throughput QC release laboratory. Participated in harmonization of assay procedures between US and European testing facilities. Reviewed data packages and audit reports. Wrote qualification and validation reports.

Emeryville, Ca

Bioassay development specialist. Represented group at team meetings and made recommendations to project teams. Bioassay development for multiple drug candidates measuring cell proliferation, apoptosis, and immunogenicity. Bioassay method improvement, troubleshooting, and transfer. Independently wrote development reports, standard operating procedures, validation protocols, and validation reports. Supervised direct report.

Emeryville, Ca

Biological assay method development. Developed potency assays for product release, pharmacokinetic profiling, and immunogenicity. Organized and presented work at project team meetings. Adapted existing assays to meet needs of other projects resulting in significant savings in development time and cost. Introduced more efficient methods of performing key assay steps that resulted in cost savings and higher performance. Trained and mentored Quality Control and Analytical Operations department staff.

Mba, Management

MBA degree in Management

Ba, Biological Science