Behrooz A. Aval

Biopharma professional, experienced in Quality Science, QA/QC, Regulatory Affairs CMC/BLA, Project Management, Bioanalytical Development, and Biologics Manufacturing. Earned a Master of Biomedical Sciences, a Bachelor of Chemistry, and a Certificate in Project management. Experienced in GxP authorship, CMC strategic planning and technical authoring and editing review for New Drugs and Biologics License Applications. Interacted and mitigated Compliance issues with CMOs and CTOs. Electronic GMP data search expert for scientific verification EDMS and data gap resolution in BLA final drafts and post FDA submission interactions. Steering Project Management experience in CMC cross functional representations and liaison roles. Expert in Quality Systems, QC, QA, assay development, technology transfer, product release, validation, compliance, audits, change control, CAPA & discrepancy, training and auditing. Conducted Bioanalytical R&D in method validation, tissue culture, and ex-vivo assays. Developed methods for autoimmune clinical studies and functioned as Subject Matter Expert trainer for Immunoassays, Capillary Electrophoresis & High Pressure Liquid Chromatography. Possess Biologics Manufacturing experience in change over, process validation, pilot scale / scale up, fermentation, commercial product recovery, and final product purification processes.