Mohamed Khedr

Mohamed Khidr Arafa is a senior R&D and Stability expert with over 13 years of experience in pharmaceutical methodology development, stability studies, and regulatory file preparation. He currently serves as Methodology & Stability Section Head at ATCO Pharma and as a Course Instructor at PharmaCores. He specializes in analytical method development, validation, verification, and transfer (Assay, Dissolution, Impurities), CTD and bioequivalence file preparation, and regulatory compliance aligned with EDA, ICH, FDA, USP, EMA, and WHO requirements. Mohamed has successfully led multiple regulatory audits (including SFDA and other authorities) with zero critical observations, bringing strong leadership, risk management, and quality-driven expertise into his training programs.

Experience

13+ Years

R&D leader with over 13 years of experience specializing in stability studies, analytical methodology, and pharmaceutical quality management.

Industry Background

Pharmaceutical R&D Methodology & Stability

Advanced through progressive QC and R&D roles at SABAA Pharmaceuticals, Pfizer, and SAJA Pharmaceuticals to his current position as Section Head at Atco Pharma.

Academic Background

Master of Science in Quality Management Systems (QMS)

Holds an MSc in QMS from the Arab Academy for Science, Technology & Maritime Transport, alongside postgraduate diplomas in Analytical Bio-Chemistry from Minufea and Mansoura Universities.

Areas of Contribution

Pharmaceutical QualityResearch and DevelopmentAnalytical Method Development

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