Ismail Essam

R&D Methodology SpecialistFull Time

HPLC AnalystFull Time

• Job Details:As an HPLC Analyst, my role involves method development and validation for drug analysis, which includes assessing linearity, accuracy, precision, selectivity, peak purity, and robustness. I perform dissolution testing, assay analysis, and content uniformity testing. Additionally, I handle lab tasks such as calibrating instruments (balances, micropipettes, pH meters), preparing chemicals, buffer solutions, mobile phases, and dissolution mediums. I process and analyze data using Empower 3 software and Microsoft Excel, ensuring accurate results. All my activities are conducted in compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and the ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate). My work strictly follows guidelines from the USP Pharmacopeia, FDA, GCC, and ICH regulations. I specialize in method development to determine the optimal analytical approach for specific drugs and conduct method validation tests, including linearity, accuracy, specificity, intra/inter precision, peak purity, and dissolution across various mediums. My work aligns with USP, FDA, and EDA regulations, and I strictly adhere to GLP practices. Additionally, I conduct assay, content uniformity, Weight Variation and dissolution tests post-method validation, operate HPLC instruments, process raw data in Excel, and troubleshoot HPLC-related issues. I am also well-versed in GCC Guidelines and ICH M13 Guidelines for bioequivalence studies.