Hatem H. Nasser

• Working on AVD projects for oral solid dosage forms
• Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer as applied to solid oral dosage formulations
• Collaborate with project management (PM) function to lead execution of activities against approved plan
• Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.)
• Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders
• Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction
• Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
• Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.

• Perform necessary literature and patent search to support studies for development of drug products and generate data/development reports for use by the sponsors as part of their regulatory submissions, such as ANDA filing or patent filings.
• Assist senior scientist/ group leader to plan, perform and lead various stages of product development, including pre-formulation, formulation development, process development, optimization, scale-up studies/technology transfer
• Incorporate Quality-by-Design tools in drug development. Develop prototype formula and evaluate the predetermined QTPPs and CQAs, and continue to improve the formula to reach the development goal
• Write and review GMP documentation, including manufacturing batch records, and appropriate study protocols, and interface with CTM Manufacturing Team for transfer of knowledge for CTM Batch Manufacturing
• Analyzed problems and worked with teams to develop solutions.

• Perform pre-formulation/formulation studies for product development of solid dosage form.
• Actively associated with multiple company projects to troubleshoot problems related to capping, lamination, sticking, picking, content uniformity, and release kinetics.
• Review and write standard operating procedures, protocols, and reports.
• Trained to work on - Tablet Press (8, 16, Single Station) - Fluid Bed Dryer (FBD) - Spray Dryer - Hi-Coater - High Shear Granulator/Roller Compactor - Hot Melt Extruder (HME) .

• Assist with conducting sample analysis/material characterization from third company, contract research and manufacturing organizations (CRO’s & CMO’s) and compounding pharmacies.
• Writing and developing current and new standard procedures associated to instruments and laboratory practices.
• Proficient and trained on - Differential Scanning Calorimeter (DSC) - Thermogravimetric Analysis (TGA) - Moisture Sorption Analyzer - Attenuated Total Reflectance (ATR-IR) - X-Ray Powder Diffraction (XRPD) - Dissolution Apparatus (USP I, II) - Ultra-Performance Liquid Chromatography (UPLC) - Discovery HR 30 Rheometer - Ft-4 Rheometer -Texture Analyzer (TA.XT).

Responsible for observing, cultivating quality, and compliance targets.

• Analyzed Cephalosporin’s medication in QC laboratories by using HPLC, GC, TLC, Karl Fischer, and Polarimeter in the interest of quantifying the amount of the drug in registered drug products to keep tracking of drug consistency and post-marketing surveillance.