Rowida Abdelgalel, Ph.D. Email & Phone Number

Chapel Hill, Nc, Us

Chapel Hill, Nc, Us

Boston, Massachusetts, Us

• Provide strategic and managerial oversight of bioanalytical operations including bioanalytical method development, validation, and sample analysis.• Manage assay development and/or technology transfers to ensure the scientific quality of data meets regulatory expectations.• Troubleshoot technical issues and improve product quality.• Proactively anticipate technical issues that arise during project execution and consult with management and project teams to expedite timely resolution.• Draft and review study protocols, interpret bioanalytical data, author and/or review study reports.• Monitor the production of regulatory documents generated within bioanalytical operations, in collaboration with Quality teams.• Author and/or review regulatory documentation.• Maintain a broad knowledge of state of the art principles, theory, and application of bioanalytical sciences.• Leverage bioanalytical assay capabilities to add value and construct a fundamental understanding of the pathway biology and regulation of the drug/target• Lead in identifying, evaluating, and implementing novel technologies to address challenges in drug development.

Durham, North Carolina, Us

Responsible for the technical conduct of the bioanalytical phase of clinical and non-clinical studies.Manages the analysis and conducts scientific review of the assay result .Oversees assay development, qualifications, and validation. Conducts data analysis and principal investigation to ensure completion within study timeline and compliance with applicable SOPs/regulations.Develops and maintains good working relationships with Sponsors.Provide day to day study management oversight by planning, coordinating and managing all study related activities.Collaborates with sponsors on assay development, assay qualification, assay validation, study design and project technical requirements.Authors validation protocols, analytical plans, analytical reports, validation reports, technical methods and SOPs.Oversees the technical writing of analytical reports for the vaccines unit.Works closely with the vaccines project leaders , sample management staff to oversee the resolution of sample test in questions and sample ID discrepancies for the vaccines unit.

Durham, Nc, Us

Lead the development, and qualification of bioanalytical ligation binding assays/ immunoassay, Lead the validation of bioanalytical method according to GLP guidelines. Supervised analysts 1-3. Conducted routine sample analysis for clinical and pre-clinical studies. Assure successful and timely execution of assay validation and sample analysis under GLP, GCP, and GCLP. Conducted analyses for pharmacokinetic, biosimilars, biomarkers, and anti-drug antibodies bioanalytical projects. Proficient in using Watson LIMS and Gen 5 software. Leverage expertise in bioanalytical techniques such as Singleplex/Multiplex electrochemiluminescent immunoassay, and ELISA. Wrote bioanalytical Method, report, Plans in support of method validation and sample analysis

Durham, Nc, Us

Researched, developed, qualified of bioanalytical ligation binding assays/ immunoassay, Lead the validation of bioanalytical method according to GLP guidelines. Supervised analysts 1-3. Conducted routine sample analysis for clinical and pre-clinical studies. Assure successful and timely execution of assay validation and sample analysis under GLP, GCP, and GCLP. Conducted analyses for pharmacokinetic, biosimilars, biomarkers, and anti-drug antibodies bioanalytical projects. Proficient in using Watson LIMS and Gen 5 software. Leverage expertise in bioanalytical techniques such as Singleplex/Multiplex electrochemiluminescent immunoassay, and ELISA. Wrote bioanalytical Method, report, Plans in support of method validation and sample analysis.

Medical Laboratory Scientist: Working in a CLIA regulated diagnostics laboratory. Handling infectious material under biosafety level 2 and 3 laboratory setting. Design assays, validation plans, and writes technical documents. Perform molecular diagnostics of infectious diseases using molecular biology tools including manual and automated nucleic acid extractions from biological specimens, PCR, qPCR, RT-qPCR, Sanger sequencing and next-generation sequencing. Perform tissue culture in viral diagnosis. Performed Molecular diagnostic method development, and method validation under CAP/CLIA regulations.

Tempe, Az, Us

Molecular biologist trained in virology and vaccines development with more than 5 years of laboratory experience, graduated from microbiology doctoral program in December 2016. My research aims to generate a novel vaccination strategy to control the spread of vector-borne arboviral diseases caused by Flaviviruses. Uses virus reverse genetics to generate a pediatric divalent recombinant measles vaccine to protect against measles, Zika, yellow fever, and Dengue viruses infection.

Tempe, Az, Us

Worked on a project uses tobacco plant as a system for producing pharmaceutical proteins ( ie, antibodies). Using syringe and vacuum agroinfiltration as gene delivery methodologies.

Doctor Of Philosophy (Ph.D.), Microbiology, General

Master’S Degree, Biology

Bachelor’S Degree, Biotechnology