Experience

• 

  Amriya for pharmaceutical industries s.a.e

  May 2007 - Apr 2009

  Formulation r&d specialist

  • Conduct literature search for the projects including publications, patents, etc.• Conduct physical and chemical characterization of comparator RLD).• Conduct pre-formulation, compatibility and stress testing studies.• Execution of formulation & process development for different dosage forms.• Evaluate quality and technical performance of dosages under development.• Perform scale up & technology transfer to production scale.• Prepare manufacturing relevant documents.

• 

  European egyptian pharm. ind., pharco corporation

  May 2009 - Apr 2021

  Manage stability testing in case of; new products, change in storage conditions, shelf-lifeexpansion/reduction, change of manufacturing site & in case of updated specifications.• Design the processes of in-use stability studies.• Review and approve stability protocols and reports.• Evaluate deviations, (OOSs & OOT), provide inputs for Nonconformity system (NCR)and follow up CAPA implementation.• Respond to inquiries raised by health authorities and provide needed clarifications,commitment and/or justifications.• Ensure stability testing is done in compliance to MOH, ICH, and WHO regulations andfollow Data integrity principles. عرض أقل • Design & review execution of formulation, for generic new products, and processoptimization for products under redevelopment for different dosage forms.• Follow up commercial troubleshooting & monitor technology transfer activities for tollmanufacturing.• Review & analyze all scientific data required to support processes of drug registrationand reregistration.• Review & approve SOPs, manufacturing related documents such as: batch productionrecord, sampling plan, validation reports and holding time study protocol in addition tothe documents required for local and external registration purposes.• Supervise any changes in product composition, manufacturing process, specifications, orbatch size & follow up through Change Control System (CCR).• Set work plan based on priorities and allocated resources and ensure consistent day-to-day follow up to ensure project progress meets the time frame.• Ensure all development activities in compliance with cGMP, GLP, FDA & ICHguidelines. عرض أقل •Planning & execution of formulation, for generic new products, and process optimizationfor products under redevelopment for different dosage forms.• Execute technology transfer activities for toll manufacturing.• Follow up commercial troubleshooting.• Determine the new APIs and excipient specifications.• Review the results of pre-formulation, compatibility and stress testing studies.• Generate &/or review all technical relevant documents as protocols, reports,manufacturing documents and SOPs.• Lead R&D team in the execution of the trials, assign tasks, provide feedback.• Supervise training of subordinates to maintain personnel proficiency and adequatetechnical skill levels. عرض أقل

  • Stability Studies Manager

    Aug 2018 - Apr 2021

  • Formulation R&D Deputy Manager

    Jun 2016 - Jul 2018

  • Formulation R&D Section Head

    Jun 2013 - May 2016

  • Formulation R&D Specialist

    May 2009 - May 2013
• 

  Amriya for pharmaceutical industries s.a.e

  Dec 2020 - now

  Formulation r&d manager

  • Plan, design & manage new products development strategy including pre-formulation,formulation, process development, lab scale trials, scale up trials, & pilot batches.• Execute, coordinate & monitor technology transfer activities for toll (in/out)manufacturing with concerned parties.• Manage & design redevelopment and process improvement for current products.• Manage & follow up troubleshooting for the commercial batches.• Review & approve the manufacturing documents in addition to the documents requiredfor local market and export.• Recommend & participate in technical evaluation of new equipment based on newlydeveloped product needs.• Collaborate with Business Development through analyzing market research outcomes tomake decisions for cost, ingredients substitution and applied technology.• Setting the department annual budget for the department in coordination with the Finance& ensure R&D projects delivered on time and within that budget. عرض أقل