Our Team

Amanda joined Biologics Consulting in September of 2025.and has over a decade of project management experience at the FDA in CBER’s Office of Compliance and Office of Regulatory Operations. She has experience leading cross-functional review teams through all phases of product development and lifecycle management and has a proven track record managing complex regulatory submissions and ensuring compliance with federal regulations.

Amanda gained valuable federal policy experience during her tenor at the Office of Operations in CBER. Amanda served as CBER’s subject matter expert for formal meetings with sponsors and developed several SOPs and procedures for use both by CBER staff and external stakeholders. She participated in several modernization projects and cross-center committees with CDER and CDRH to help streamline CBER’s processes.

Prior to this, Amanda worked at CBER’s Office of Compliance and Product Quality. She gained vital experience with all submission types, from pre-IND through to BLA and post market supplements and reports. She served as the point of contact for applicants and sponsors and managed multidiscipline teams in the review of regulatory submissions from receipt through approval, including PAI and PLI inspections.

Amanda worked at NIH before moving to FDA where she managed grants and contracts for both NIAID and NCAAM. She has also worked in research and development for a vaccine company. Amanda has a Bachelors of Science degree in Biological Sciences from University of Maryland Baltimore County.