Jobs at eGenesis

Lead end-to-end monthly, quarterly, and annual close (GL, AP, accruals) and deliver US GAAP financial statements. Account for R&D, clinical trial accruals and CRO vendor arrangements. Design and maintain ICFR/SOX readiness and audit-ready disclosures. Manage a Senior Accountant and own NetSuite as the system of record, partnering with FP&A to improve processes and reporting.

Lead clinical development planning and execution for engineered-organ programs. Design protocols, oversee study conduct and data review, support regulatory submissions, collaborate cross-functionally, and drive process improvements to ensure scientific rigor and operational excellence.

Support QA to implement and manage quality systems for GMP manufacturing and testing across sites. Manage deviations and CAPAs, administer ELN for batch records and test methods, handle documentation and training programs, develop and report quality metrics, support cGMP/ISO/FDA-compliant policies and procedures, mentor staff, review executed records, and drive process improvements and special QA projects.

Manage day-to-day clinical trial operations, vendors, and sites; maintain TMF and study documentation; ensure compliance with SOPs and ICH-GCP; lead cross-functional study communications, timelines, and risk mitigation; coordinate audits and resolve findings.

Develop, optimize, troubleshoot, and execute analytical assays to characterize transgene expression and function in genetically edited porcine cells. Perform primary cell isolation and mammalian cell culture, and run flow cytometry, ELISA, and PCR-based assays. Maintain reagent inventory, document data in ELNs, lead internal technology transfers with QC, conduct root-cause analyses for assay issues, and present findings to cross-functional teams in a fast-paced start-up environment.