SIMONE SUMNER CUMMINGS

Results-driven leader with extensive experience in FDA- and EPA-regulated biotechnology industries. Demonstrated expertise in project and program management, process optimization, quality management, and bioanalytical method validation. Skilled at driving change, fostering innovation, and ensuring compliance with regulatory standards. Excels in cross-functional collaboration, CAPA development, and stakeholder management to improve efficiency and achieve organizational goals.

• Project Management Professional (PMP), 2021
• CAPA & Risk Management Training
• Regulatory Compliance (GLP)

• WO17044310 – Compositions and Methods for Protein Detection, Developed antibody pairs for detecting and quantifying Cry1Ab protein in hybrid sequences.
• Immunoassays and Mass Spectrometry for Determination of Protein Concentrations in Genetically Modified Crops, Wang, Y., Bednarcik, M., Ament, C., Cheever, ML., Cummings, S., et al., 2024, J. Agric. Food Chem., 72, 8879-8889
• Methods to Support Protein Extraction Efficiency from Plant Tissues, Serrano, H., Jiang, X., Ghoshal, D., Wang, Y., Komorek, J., Ahi, L., Gao, A., Kouba, K., Atkinson, T., Ament, C., Birukou, I., and Cummings, S., 2024, AEIC White Paper