Teams at Aura Biosciences

Conduct laboratory experiments supporting analytical method development, qualification, transfer, and characterization of biologic products, including VLPs. Perform cell culture, cytotoxicity assays, molecular biology testing, qPCR, ELISA, electrophoresis, and stability studies. Troubleshoot assays and instruments, maintain compliant documentation, prepare technical reports and methods, and collaborate with internal teams, CDMOs, and CROs. Serve as a subject matter lead for assigned techniques and present scientific findings.

Provides strategic oversight and governance of Trial Master Files across clinical studies. Ensures complete, accurate, inspection-ready documentation compliant with ICH-GCP, regulations, and SOPs. Oversees eTMF systems, CRO and vendor relationships, TMF reviews, reconciliations, metrics, inspections, audits, training, and CAPA activities. Collaborates with clinical, regulatory, quality, biostatistics, data management, and pharmacovigilance teams, while potentially managing or mentoring TMF staff.