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Biotech • Pharmaceutical • Industrial • Manufacturing
Leads the design, licensing, CLIA certification, validation, launch, and stabilization of a new clinical laboratory supporting oncology and microbiology. Coordinates facility and equipment implementation, regulatory submissions, quality systems, assay validation, LIS/LIMS selection, personnel competency, inspections, deficiency responses, CAPA, and continuous improvement.
Biotech • Pharmaceutical • Industrial • Manufacturing
Leads clinical operations for longevity and oncology studies from feasibility through closeout. Responsibilities include translating protocols into operating plans, managing site and vendor start-up, coordinating CROs and investigators, overseeing budgets, enrollment, monitoring, documentation, risks, and inspection readiness. The role also develops SOPs, supervises clinical operations staff, supports audits, and reports study progress to leadership.



