Mohamad Gamal M.S.

Compliance Officer

Mr. Gamal earned his B.Sc in Pharmaceutical Sciences at Cairo University in 2004. Mr. Gamal then completed his M.S. in Quality Management and application of lean six sigma in biopharmaceutical industry. Mr. Gamal is a manager of Quality and Organization Excellence certified from the American Society for Quality in 2011. As a Quality Manager, in each of Mr. Gamal’s positions, he facilitates and leads team efforts to establish and monitor customer/supplier relations, supports strategic planning and deployment initiatives, and helps develop measurement systems to determine organizational improvement.

Since 2008, Mr. Gamal has been the R & D unit head at Sigma Pharmaceuticals in Cairo, Egypt and is involved in many projects pertaining to novel product formulations. Specifically, he is responsible for developing new marketed solid dosage formulations, production, and scaling up analytical methodology and technology transfer to production and quality control departments.

In addition, Mr. Gamal is responsible for the design, execution, interpretation, formulation and process development experiments leading to the development and optimization of various oral pharmaceutical dosage forms and drug delivery systems for commercialization. Mr. Gamal is currently validating and implementing methodology for conducting stability testing protocols for new chemical entities and pharmaceutical products.

From a preclinical perspective, Mr. Gamal contributes pre-formulation and formulation expertise characterization and development of potential drug delivery systems and platforms. Specifically, he is responsible for manufacturing clinical supplies to support preclinical and clinical studies of elected pharmaceutical formulations. 

Previously, Mr. Gamal was a Fermentation Area Specialist for Rhein Biotech in Egypt where he was resposbile for assuring that the manufacturing equipment and processes were in compliance with safety and quality standards while supporting implementation of various changes and improvements. He worked closely with other departments, including Manufacturing Technology, Validation and Facility Operations, QC/QA. Mr. Gamal implemented protocols to directly support the manufacturing of biopharmaceuticals by following SOPs/GMPs, providing high-level technical support, and consulting regarding the fermentation, recovery, and purification processes. In addition, he worked with scientists to report results of experiments and analyzes data to assist in technology transfer.

Previously, Mr. Gamal was the QC Analyst for Lacto Misr for Baby Milk & Foods in Egypt. As QC Analyst, he was responsible for conducting chemical analysis of raw materials and finished products using validated, analytical methods. In addition, Mr. Gamal performed instrumental analysis using HPLC, IR, NIR and UV for products to ensure QC.

Mr. Gamal has significant experience working with manufacturing equipment such as stainless steel tanks, bioreactors, centrifuges, filtration systems, chromatography systems, control systems, DCS, PLC, SCADA, and CIP/SIP systems on an industrial scale. Furthermore, Mr. Gamal has conducted method development and validation with analytical instrumentation such as HPLC and GC/MS systems, and LC/MS/MS setups. In addition, he is knowledgeable on the processes of microbial fermentation, protein refolding, and protein purification.

Overall, Mr. Gamal is a research scientist with extensive experience in the pharmaceutical industry and carrying out formulation and development studies of solid dosage forms from lab-scale to pilot under cGMP conditions. Furthermore, he has experience in an FDA regulated environment as well as familiarity with issues of compliance with Ministry of Health regulations. Mr. Gamal also as extensive experience in regulatory affairs and preparing the necessary documentation for preclinical in vivo and/or in vivo/in vitro screening.