About this role
2025-2030 Focus: The Materials Physical Properties Characterization Expert Committee focuses on developing and refining analytical methods for the physical characterization of powders, liquids, and compounded or formulated drug products. This includes standards and guidelines for analytical procedures for the material's physical properties characterization and quality control, including input and in-process materials used in the manufacturing of a drug product and/or its components.
2025-2030 Key Issues:
• Instrumental Determination of Color: Advancing the use of instrumental techniques for color determination in pharmaceutical products.
• Microscopy Techniques: Enhancing the use of microscopy for analyzing and characterizing crystalline structures in pharmaceutical products.
• Image Analysis of Particles: Advancing image analysis techniques for characterizing and quantifying particles in pharmaceutical products.
• Powder Analysis: Improving methodologies for the analysis, characterization, and handling of powders in pharmaceutical applications.
• Rheological Techniques: Advancing the application of rheological techniques in pharmaceutical research, development, and manufacturing.
• Solution Preparation and Stability: Enhancing practices related to the preparation, testing, and stability of solutions in pharmaceutical formulations.
• Osmolality and Osmolarity Measurement: Advancing methodologies for measuring and controlling osmolality and osmolarity in pharmaceutical products.
• Solubility Measurement: Improving methodologies for accurately measuring solubility in pharmaceutical research and development to ensure product efficacy, bioavailability, and regulatory compliance.
Required Expertise:
• The GC-MPPC Expert Committee is seeking a candidate with demonstrated expertise in the physical and physicochemical characterization of pharmaceutical materials and dosage forms. The ideal candidate should have substantial experience in one or more of the following areas:
• Solid-state characterization of drug substances, excipients, raw materials, and formulated products, including polymorphism, crystallinity, thermal behavior, moisture interactions, surface area, porosity, and particle-size distribution. Powder characterization and the evaluation of material attributes that affect formulation development, manufacturing performance, product stability, and quality.
• Microscopy and particle imaging techniques, including scanning electron microscopy, atomic force microscopy, and image-analysis software used to characterize particle morphology and crystalline materials.
• Instrumental measurement and quantitative analysis of color and appearance in pharmaceutical materials and products.
• Solubility and preformulation studies, including pH-solubility profiling, salt and polymorph screening, pKa determination, solubilization, drug-excipient compatibility, and solution and solid-state phase behavior.
• Solution preparation, degradation kinetics, and stability assessment, including the evaluation of formulation, packaging, and storage variables affecting product performance.
• Osmolality or osmolarity measurement, including experience with vapor-pressure or other appropriate osmometric techniques.
• Development, validation, transfer, and regulatory application of analytical procedures used to assess the physical properties and critical quality attributes of pharmaceutical materials and products.
• Experience applying Quality-by-Design principles, establishing specifications, supporting CMC submissions, and working within cGMP and ICH frameworks is highly desirable.
Preferred Expertise:
• Powder characterization and the evaluation of material attributes that affect formulation development, manufacturing performance, product stability, and quality.
• Microscopy and particle imaging techniques, including scanning electron microscopy, atomic force microscopy, and image-analysis software used to characterize particle morphology and crystalline materials.
• Osmolality or osmolarity measurement, including experience with vapor-pressure or other appropriate osmometric techniques.