Robotics Automation Specialist

2 weeks ago

Morrisville North Carolina, United States SAGA Diagnostics Full time

SAGA Diagnostics is at the forefront of personalized cancer diagnostics and disease monitoring, specializing in molecular genetic analysis of circulating tumor DNA (ctDNA).

Our mission is to enhance precision cancer medicine, offering more accurate treatment monitoring and improving patient survival through minimally-invasive liquid biopsy cancer testing services.

With our proprietary tests, we empower patients, oncologists, and drug developers to detect actionable mutations, stratify patient groups, and monitor treatment responses, residual disease, and disease recurrence with unparalleled sensitivity and scale.

We are currently seeking an Automation Scientist to spearhead the development, deployment, validation, and support of our liquid handling instruments and methodologies within our clinical laboratory.


The Automation Scientist will be an integral part of a dynamic automation team, tasked with creating semi/fully automated robotic workflows and providing ongoing support for these systems.

The ideal candidate will possess experience collaborating across various projects to develop, optimize, test, and implement robust automated solutions for reagent manufacturing, digital PCR, or NGS assay workflows, particularly in a regulated diagnostic environment.

This role also involves partnering with external vendors to devise integrated robotic solutions that meet comprehensive business and user requirements.

We are looking for a motivated and adaptable team player who thrives in a fast-paced, collaborative environment.

As part of SAGA, you will contribute to our rapidly expanding cancer genomics offerings, gaining international recognition and strong customer engagement.

Key Responsibilities:

  • Collaborate with automation team members across multiple sites to identify, develop, and refine semi/fully automated robotic workflows to support molecular diagnostic production.
  • Provide on-site technical assistance for automation platforms.
  • Develop unit tests to ensure the functionality of liquid handling systems following repairs and service events.
  • Create and maintain Verification/Validation protocols and related technical documentation to facilitate process transfers into production.
  • Work alongside Clinical Operations and Regulatory teams to validate products and ensure compliance with necessary guidelines and regulations.
  • Program, optimize, verify, and qualify new or enhanced automated methods for reagent manufacturing, digital PCR, and next-generation sequencing assays.
  • Analyze workflows to identify bottlenecks, devise solutions, and lead teams in implementing improvements that enhance efficiency, throughput, cost-effectiveness, and quality.
  • Ensure timely completion of team tasks with a focus on quality.
  • Draft design documents, user requirements, functional specifications, SOPs, and Bills of Materials for new and existing automated systems.
  • Install, test, and manage new versions of automated protocols across laboratories.
  • Provide training and documentation for new or modified workflows to end users.
  • Coordinate with vendors for necessary maintenance and calibration, ensuring compliance with regulatory documentation requirements.
  • Work cross-functionally to identify areas for streamlining and enhancing user experience.
  • Generate and maintain requirements and test plan documentation.
  • Integrate instrument components and conduct unit testing.
  • Execute optimization studies to enhance and characterize automated methods for improved robustness.

Requirements:

  • Availability for on-site work during the first shift.
  • Experience in automation, qualification, and troubleshooting of molecular biology or NGS assays.
  • Proficiency in writing, optimizing, and testing methods on liquid handling platforms commonly used in high-throughput biotechnology labs.
  • Experience in process development, optimization of assays, and support in both manual and automated settings.
  • Familiarity with ISO 13485, ISO 15189, GMP, or similar regulated environments.
  • Strong background in DNA/RNA extraction and Next Generation Sequencing technologies.
  • A creative and pragmatic approach to enhancing technologies.
  • Excellent communication skills and a passion for collaboration across teams.
  • A proactive attitude and willingness to engage in a fast-paced environment.

Benefits:

The opportunity to innovate cutting-edge automation solutions for genomic diagnostics.

As an early member of our team, you will play a vital role in shaping the direction and culture of our growing organization.

Enjoy the autonomy and resources necessary to achieve the highest standards.

Participate in SAGA's Equity scheme.

Experience the perks of a start-up environment, including competitive salaries, excellent IT support, team events, flexible working arrangements, and a dynamic workplace culture.

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