2025-2030 Focus: Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new ones Selected general chapters that pertain to the above therapeutic classes Identification and development of new tools, chapters, monographs, RS and ARMS. 2025-2030 Key Issues: Collaborate with other Biologics Expert Committees, FDA and stakeholders to improve existing monographs/chapters/tools and develop new vaccine related chapters/tools, RS and ARMs Conduct workshops relevant to areas of interest to the Expert Committee Related Expert Bodies Required Expertise: The mRNA Expert Panel seeks members with demonstrated expertise in mRNA manufacturing and analytical characterization, including areas such as IVT processes, plasmid DNA starting materials, cap and poly(A) tail characterization, size and integrity assessment, and impurity analysis (e.g., dsRNA, residual DNA, NTPs). Experience with analytical methods (LC, LC MS, IP RP HPLC, electrophoretic techniques), quality and lifecycle management, and the use of reference materials is highly valued. Familiarity with regulatory expectations and compendial standards, along with the ability to contribute collaboratively in a consensus driven, standards development setting, is essential.