Abd El- Halim El- Kishky

R&D technology leadFull Time

• Job Details:Highly energetic and committed formulator with academic background and 10 years practical experience in formulation. I am eager to use my proven skills as a supervisor formulator in your well established pharmaceutical company. Performing pre-formulation & formulation trials for the new products or products under redevelopment. Performing material and finished product specifications and contact with supply chain department to ensure the specifications required. Performing pilot trials. Review active material and quality files with suppliers Processing all lab tests required for the new formulations and follow up all the physical and chemical testing. Participating in transforming R&D product development efforts into scalable manufacturing process and robust and quality products. Preparing all the documentations of new formulation file. Carry out experimental trials and validation methods for the analysis and quality control of products, and raw materials. Assist in scaling up of new and development products via plant trials, making changes to raw materials or components and process parameters to ensure that targeted product quality is maintained during large -scale production. Providing standard operating procedures for different lab equipment and general test procedures for different pharmaceutical dosage forms. Supervising the proper operation, maintenance and qualification/calibration of different lab. instruments. Preparing literature review of new drug product including initial product composition, proposed manufacturing process, API specifications, excipients specifications, finished product specifications and packaging material specifications. Implementation of QBD with DOE and risk based approach during pharmaceutical development of new drug product. Prepare a technology transfer protocol. Supervise and implementation of scale up from lab. scale through pilot to commercial batches. Troubleshooting and investigation of the problems during the manufacturing of the finished drug products. Supervising and preparing module 3 in CTD format as required by regulators. Participating in the design and implementation of process validation program, cleaning validation program, product hold time study.

R&D section headFull Time

• Job Details:Performing pre-formulation & formulation trials for the new products or products under redevelopment. Performing material and finished product specifications and contact with supply chain department to ensure the specifications required. Performing pilot trials. Review active material and quality files with suppliers Processing all lab tests required for the new formulations and follow up all the physical and chemical testing. Participating in transforming R&D product development efforts into scalable manufacturing process and robust and quality products. Preparing all the documentations of new formulation file. Carry out experimental trials and validation methods for the analysis and quality control of products, and raw materials. Assist in scaling up of new and development products via plant trials, making changes to raw materials or components and process parameters to ensure that targeted product quality is maintained during large -scale production.