Betty Shiberu

• Develop and validate FDA/ICH compliant HPLC/UPLC methods for recombinant therapeutic proteins, Viruses and impurities in support of phase 1 clinical trials. • Develop and validate ELISA and PCR assays for recombinant therapeutic proteins and Viruses for in-process and lot release samples. • Perform Immunoenzymatic assay for the measurement of host cell proteins. • Perform RT-qPCR assay for quantification of virus particles and residual DNA in DS and in-process therapeutic proteins, viruses and peptide samples. • Generate SOPs, research protocols and study reports for developed assays. • Assist in general lab organization and operations. • Laboratory safety manager.

Acquire, optimize and troubleshoot HPLC, RT-qPCR and Western Blot methods from development group in support of HIV, Ebola, Influenza and Zika vaccine research and production for clinical trials. • Conduct routine and non-routine analysis of DS, DP, IP and stability vaccine samples. • Perform data analysis, review, interpret data findings and investigate issues and report data abnormalities • Ensure performed activities are in compliance with SOPs, FDA, cGMP and GLP regulations. • Participate in OOS investigation and recommend corrective action. • Optimize and troubleshoot analytical methods used for analyzing vaccines. • Responsible for method transfers and method qualifications from R&D laboratory. • Draft and revise SOPs, qualification and method development reports. Area of expertise • HPLC & UPLC Method Development • ELISA Method Development • RT-qPCR & Primer design • Western blot • Cell Culture • Spectrophotometer • Method Transfer • Laboratory Safety • Project Management • GMP • GCP • ICH • CFR • GDP

Develop, maintain, troubleshoot and transfer all chromatographic analytical methods for all development phase and commercial phase biologics products at Allergan. Areas of expertise: HPLC Method Development - UPLC Method Development - ELISA Method Development - Drug product characterization - Drug Substance Characterization – Microbiology - Molecular Biology - Cell Culture – Gene/Plasmid cloning – PCR – DNA Isolation - Western/Colony Immuno Blotting - QC Testing - Project Management - Method Transfer - Method Troubleshooting and Optimization - Laboratory Safety - Bio Safety Level 2 Lab Operations – Empower 2/3 – SoftMax Pro

Responsible for acquisition of HPLC (IEX, RP & SEC) and ELISA methods from method development group. Areas of expertise: HPLC Method Development - UPLC Method Development - ELISA Method Development - Drug product characterization - Drug Substance Characterization – Microbiology - Molecular Biology - Cell Culture – Gene/Plasmid cloning – PCR – DNA Isolation - Western/Colony Immuno Blotting - QC Testing - Project Management - Method Transfer - Method Troubleshooting and Optimization - Laboratory Safety - Bio Safety Level 2 Lab Operations – Empower 2/3 – SoftMax Pro

Assigned daily routine testing and some development work to subordinates and reviewed generated results. • Performed chemiluminescent Immunoassay for the detection of various medical conditions (Anemia, Cancer, Heart conditions, Diabetes, etc.) in an effort to develop new diagnostic kits and troubleshoot existing kits. • Operated Immulite instruments that were used to test diagnostic kits and supervised the daily and monthly maintenance. • Prepared reagents, buffers and solutions and ordered consumables for an efficient workflow. • Used laboratory information system to create assay work list and run samples. • Statistically analyzed data using Excel and prepared experiment summary. • Performed maintenance and calibration of analytical instrumentation, pipets and balances.

• Conducted electrophysiological research on primary rat atrial cells. • Optimized protocols and parameters for primary cell culture. • Monitored inventory and ordered laboratory supplies and animals.

•Conducted independent research that involved molecular cloning and site directed mutagenesis of different strains of H. pylori LPS biosynthesis genes and functional and biological analysis of the disrupted genes. •Designed primers for PCR, run PCR and agarose gel electrophoreses, DNA isolation, Plasmid and gene cloning. •Performed Western and colony immuno blotting, SDS-PAGE electrophoreses and made competent bacterial cells for transformation with exogenous DNA. •Taught graduate and undergraduate students principles and techniques of conducting a scientific research. •Designed research projects for undergraduate students. •Monitored the proper handling of potentially hazardous chemical and biological agents. •Implemented radiation safety regulations and directed the surveying of lab for radiation. •Managed organization and proper storage of laboratory materials and supplies in accordance with the established procedures.