● Perform Biotechnology test methods such as ELISA, Molecular biology assays, Immunochemical assays, Potency cell-based Potency Bioassays and HPLC. ● Responsible for Analytical Method Validation and verification according to reference monograph or in-house method development. 50% of QC Lab test methods successfully Validated and verified. ● Successfully initiated more than 70% of internal SOPs needed to control all the activities of the QC department.● Conduct and initiate Gap Analysis of new projects defining the Gaps and preforming a timeline to overcome the gap (Monoclonal antibodies, Vaccines and Therapeutic proteins.● Qualifying, training new analysts and technicians and leading them in most activities, offering them technical guidance.● Perform Quality, safety Risk assessment to ensure compliance in QC Labs.● Managing and Responsible for deviation management, change control management within the department.● Supervise and maintain GLP, GMP and regulations within QC Lab through Analysis and approval of raw materials, drug substances, and drug product, update specifications according to latest pharmacopeial monographs and regulatory requirements.● Leading internal business audits as well as first level auditing within various departments such as production, warehouse and identifying necessary corrective and preventive actions.● Responsible for Audit Readiness and self-inspection of laboratory departments.● EHS lab representative in monthly EHS committee and monthly EHS council.● Responsible for EHS SRAs in the lab “Safety risk assessments “

● Successfully Qualifying Environmental monitoring program for 2 production lines, QC labs consisting of 80 Labs and Production facility rooms. ● Successful qualification and monitoring of water station WFI, PW, PS with limited resources.● Initiating more than 45 SOPs needed to control all the activities in microbiology Section.● Performing Validation studies for various Microbiological activities.● Performing Microbiological test methods such as Sterility, Endotoxin, Growth promotion pathogens identification as well as utility monitoring. ● Responsible for calibration, maintenance and operation of equipment.● Reporting deviations, suspect results, OOS results and any other required reports.

● Conducted Hemagglutination testing (HA Assay) and Hemagglutination Inhibition testing (HI Assay) to ensure virus quality control.● Managed virus propagation in embryonated eggs and titrated virus for infectivity and back titration.● Developed and validated Enzyme-linked immunosorbent assay (ELISA) methods for accurate virus detection.● Implemented internal guidelines (SOPs) for Virology department control at Vaccine Valley.● Performed all serological assays.● Responsible for Hemagglutination (HA) Assay, Hemagglutination Inhibition (HI) assay, Virus propagation, titration, Potency assay EID50.● Conducting virology method testing studies. ● Responsible for conducting out of specification investigation reports and agree on proper corrective/ preventive actions.● Responsible for deviation management, change control management within the department.● Responsible for review of analytical certificate of analysis for raw, drug substance and finished products (Drug product).

● Successfully led the microbiological qualification of water station and environmental monitoring program at Vaccine Valley in Egypt.● Trained and guided new analysts and technicians in various microbiological tests and water chemical analysis.● Managed documentation according to cGDP and GMP, reporting deviations and revising Certificates of Analysis.● Performing different Microbiological activities (Media preparation, growth promotion, bioburden,● Pathogen identification and utility monitoring)● Qualifying all disinfectants used inside the facility. ● Executed Successfully the environmental monitoring Qualification program for the facility for Egg Based vaccine line QC and R&D Labs.● Responsible for the microbiological Water station qualification.● Ensuring Well documentation of all activities according to current good documentation practice (cGDP) and cGMP.