Automation Engineer

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 Research Triangle Park (RTP) and is looking for an Automation Scientist to primarily develop, deploy, validate and support our liquid handling instruments and methods within the RTP clinical lab.

The Automation Scientist will be part of a small, but growing, automation team responsible for the development of semi/fully automated robotic workflows and associated equipment and providing ongoing support on these systems. The ideal candidate has experience working cross functionally on a variety of projects to develop, optimize, test and implement robust automated solutions for reagent manufacturing, digital PCR or NGS assay workflows for implementation in a regulated environment, ideally in a diagnostic environment. Additionally, this position partners with outside vendors to develop integrated robotic solutions that fully address business and user requirements. We are looking for an enthusiastic and flexible team player who will thrive in a fast-paced, dynamic, and highly collaborative environment. 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. This role would suit someone who enjoys developing and supporting the deployment of automated assays.

Key Responsibilities:

• Coordinate with automation team members at all three sites (Morrisville, NC, Cambridge, MA and Lund, Sweden) to identify, develop and optimize semi/fully automated robotic workflows to support molecular diagnostic production labs.
• Provide on-site technical support of automation platforms.
• Develop unit tests to ensure functionality of liquid handling after repairs, service events, improvements
• Generate and sustain Verification/Validation protocols (I/OQ, PQ) and related technical documents to support the transfer of processes into Production.
• Work with the Clinical Operations and Regulatory teams to validate SAGA’s products and ensure workflows fulfill necessary guidelines and regulations (CLIA/CAP, cGMP).
• Program, optimize, verify and qualify new and/or improved automated methods for reagent manufacturing, digital PCR and next generation sequencing assays on the Hamilton liquid handling workstations and integrated robotic systems.
• Analyze workflows, identify bottlenecks, develop solutions and lead teams in solution implementation that improves efficiency, throughput, cost and quality to incorporate lean manufacturing principles. Ensure all team tasks are completed within a timely manner and with the appropriate degree of quality.
• Author of design documents, user requirements, function requirement specifications, SOPs, and Bills of Materials for new automated systems and revisions to them for existing systems
• Install, test and control new versions of automated protocols on applicable instrumentation across labs and possibly across sites.
• Provide training and documentation for new or modified workflows to end users.
• Coordinate with vendors to perform required maintenance and calibration. Ensure documentation is completed according to regulatory requirements.
• Work cross functionally to identify areas that can be streamlined or build a better user experience
• Generate and maintain requirements and test plan documentation.
• Integrate instrument components and perform unit testing.
• Execute guard-banding, response surface and optimization studies to optimize and characterize automated methods to improve robustness.

Requirements

• Ability to be on-site during the first shift (7:30 am to 3:30pm), Monday through Friday
• Experience in automation, qualification and troubleshooting molecular biology or NGS assays
• Experience in writing, optimizing and testing methods on one or more liquid handling platform typically employed in high-throughput biotechnology lab (Hamilton STAR, TECAN, Agilent Bravos, Dynamic Devices Lynxes); experience with workcells integrated through scheduling software (Momentum, PAA Overlord, BioSero GBG) strongly preferred
• Experience with process development, optimization of assays, and support (both manual and automated). Including the execution of feasibility studies, verification, and validation studies to support the development and qualification of automated workflows.
• Experience working within an ISO 13485, ISO 1519, GMP or CAP/CLIA or a similarly regulated environment is a must.
• Proficiency in DNA/RNA extraction and Next Generation Sequencing technologies strongly preferred.
• A creative, inventive, and pragmatic approach to streamlining technologies.
• Clear communicator with a passion for working across teams, including LIMS, automation, technology development and operations.
• A desire to work in a fast-paced environment and a willingness to roll up your sleeves - a ‘can do’ attitude.

Benefits

• The opportunity to develop cutting-edge automation solutions for genomic diagnostics.
• As an early employee of the RTP site you will be involved in every aspect of the business and help set the direction/culture as we grow.
• You will be given the autonomy and resources to deliver to the highest level.
• Membership to SAGA’s Equity scheme.
• All the perks of a start-up – highly competitive salaries, great IT, team dinners/socials, flexible working, flat structure, and a dynamic work environment.

Primary location: Morrisville, North Carolina

Hours: This is a full-time position during the first shift (7:30 AM to 3:30PM; Monday through Friday). Some travel to other SAGA locations is expected for this position.

We handle applications on an ongoing basis and the position may be filled during the application period.

Saga Diagnostics is an equal opportunity employer, fully committed to achieving a diverse and inclusive workplace that embraces and encourages applicants of every background. The company’s policy regarding equal employment opportunity means that all decisions regarding recruitment, hiring, benefits, wage and salary administration, scheduling, disciplinary action and termination will be made without unlawful discrimination on the basis of sex, gender, race, color, age, national origin, religion, disability, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, citizenship status, pregnancy or maternity, veteran status, or any other status protected by applicable federal, state or local law. If you require reasonable accommodation in completing an application, interviewing, or otherwise participating in the employee selection process, please direct your inquiries to hr@sagadiagnostics.com.