Matthew L. Boisen

Director of Ivd Product Development Site Manager @Zalgen

Aurora, CO, US

Launched and led Zalgen’s Diagnostics Division, overseeing strategy, product development, clinical operations, and regulatory alignment for IVD programs addressing high-consequence pathogens. Directed cross-functional teams across R&D, manufacturing, quality, and clinical functions, delivering innovative ELISA and RDT platforms for Lassa fever, Ebola, SARS-CoV-2, and other emerging threats.Spearheaded the design and validation of pan-lineage Lassa diagnostics, including ELISAs and rapid tests integrated into CEPI-sponsored vaccine trials and Arevirumab-3 therapeutic studies. Managed full product lifecycle from assay concept to tech transfer and clinical validation, incorporating confirmatory benchmarking with qPCR, NGS, and pseudovirus neutralization.Oversaw multi-country GCP-compliant clinical trials in Nigeria and Sierra Leone, including protocol development, site selection, training, and data monitoring. Implemented an ISO 13485-compliant eQMS (Qualio) and led design control, V&V, and risk management to support FDA EUA, CE-marking, IVDR, and WHO EUL submissions.Directed end-to-end IVD manufacturing including cGMP processes, SOPs, QC protocols, and supply chain management. Designed ambient-stable assays for deployment in low-resource settings, enabling integration into national surveillance networks.Secured $6.8M+ in grant funding and generated $2.4M+ in diagnostic revenue by aligning product strategy with global health needs. Strengthened partnerships with CEPI, WHO, NIH, and West African health ministries to advance diagnostic access and pandemic preparedness.

Tulane University

Doctor of Philosophy (PhD)

San Jose State University

Bachelor of Science (B.Sc.)