SAGA Diagnostics is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). The company’s mission is to improve precision cancer medicine, provide more accurate treatment monitoring, and improve patient survival using minimally-invasive liquid biopsy cancer testing services. SAGA’s proprietary tests can help patients, oncologists, and drug developers detect actionable mutations, stratify patient groups, and monitor treatment response, residual disease, and disease recurrence at unprecedented sensitivity and scale. 

SAGA Diagnostics recently established a US operation in RTP and is looking for a Senior Application Scientist to be part of a high-functioning team focused on the deployment and monitoring of our assays within the high throughput RTP-based clinical lab. The Senior Application Scientist will be responsible for the testing, validation and implementation of our novel MRD assays in our high-throughput molecular diagnostic laboratory. We are seeking a highly motivated senior scientist with strong experience in automated assay deployment, analytical validations and troubleshooting. The Senior Application Scientist will interface with internal partners to achieve project goals, milestones, and timelines. In addition to the criteria below, the ideal candidate must be a skilled scientist with strong study design and data analysis skills, be able to work independently, handle multiple tasks in parallel, and communicate effectively with all levels of the organization. The ideal candidate has experience in developing and qualifying processes for CLIA/CAP or IVD product(s). This is an exciting opportunity to help form a team and work closely with an exceptional R&D team based in Lund (Sweden), Cambridge (MA) and a highly experienced Clinical Operations team (RTP).

You will be joining SAGA at an exciting time, we are rapidly scaling our cancer genomics offering with excellent momentum, international attention, and strong customer traction. You will be able to help grow the company and make a real difference for people with cancer worldwide. 

Key Responsibilities: 

• Perform testing of assays within RTP, guiding parts of the tech transfer, training and analytical/clinical validation studies.
• Oversee data analysis of KPIs, and process monitoring of deployed workflows to identify areas for process improvement. 
• Complete holistic reviews of our assays/products and work with the rest of the R&D team and Clinical Operations team to identify innovative solutions to scale and streamline SAGA’s assays.
• Execute studies in support of the integration, verification and validation of automated molecular biology and next-generation sequencing assays under quality system regulation and design control.
• Serve as the technical expert to help troubleshoot deployment challenges by working closely with the clinical operations team and R&D team. Resolve issues quickly to support continued flow of business. 
• Ensure all studies are conducted utilizing Good Lab Practices and maintain documentation required to meet CLIA/CAP/QSR requirements for Design Control and other international standards (e.g. ISO 13485). 

This role would suit someone who enjoys rolling up their sleeves to deploy assays and wants to work in a fast-paced team at high-growth start-up.