Senior Scientist, Technology Development

Harbinger Health is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis, and management. Incubated within Flagship Pioneering for three years before launching in 2021, Harbinger combines advances in artificial intelligence with proprietary insights into the biology of early cancer cell formation to identify cancer before it is visible or symptomatic with the aim of developing low-cost, multi-cancer blood tests.

At Harbinger, we intend to lead in shaping this future - creating a proactive paradigm so that people can live cancer-free for longer, adding years to life and life to years. We envision a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies.

Our answer starts with proprietary solutions we are developing with our platform technology. By making cancer screening accessible on a global scale, Harbinger Health has the potential to fundamentally change cancer care, for everyone.

Our lifesaving work is grounded by our principles of rigor and transparency, constructive engagement, inclusiveness, accountability and quality, and a strong commitment to our customers, patients, and each other. These values drive our decisions and actions. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.

Position Summary

As a Senior Scientist, Technology Development at Harbinger Health, your work will advance the Product Development of our Multi-Cancer Early Detection assay. This role is crucial in shaping the assay processes, refining the laboratory workflow, and enabling the transition to high-throughput automated platforms. Your role is critical in driving the continuous improvement of our cutting-edge test, focusing on assay optimization, reagent integration on automated platforms, workflow development, and tackling complex challenges. Your experience with automating NGS assays and transitioning bench-based workflows to robust, automated platforms will be invaluable in integrating scalable genomic data generation components with automation and software solutions.

Responsibilities:

• Utilize process engineering expertise to enhance efficiency and robustness in assay development and technology transfer.

• Implement knowledge of molecular biology to cultivate robust, streamlined workflow products.

• Coordinate R&D experiments, working with a cross-disciplinary team to facilitate the transition of lab workflows to automated platforms.

• Scale and transfer the LDT assay from an R&D environment to a CLIA-certified production setting.

• Characterize assays to identify critical process parameters and system tolerances.

• Collaborate with the automation team for production planning, ensuring alignment with CLIA regulations and equipment capabilities.

• Engage in process mapping, risk assessments, and support continuous improvement initiatives through operational change management.

Basic Qualifications:

• Ph.D., M.S. in Engineering or Life Science with a minimum of 5 years of industry experience.

• 3+ years' experience in the Diagnostics and/or Genomics.

• Demonstrated proficiency in applying new engineering principles.

• Troubleshooting expertise in NGS assay protocols, including library preparation and target enrichment.

• Proven track record in process development, specifically in integrating assays with automated liquid handlers.

• Ability to independently manage multiple projects in a dynamic environment.

• Excellent communication skills and a collaborative spirit, matched with a strong commitment to quality and safety.

• Background in developing and implementing clinical laboratory tests within CAP/CLIA or FDA-regulated frameworks.

Preferred Qualifications:

• In-depth understanding of CLIA regulations and documentation best practices.

• Experience with NGS assay protocol troubleshooting, particularly on automated liquid handlers.

Harbinger Health is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Harbinger Health does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Harbinger Health or its employees is strictly prohibited unless contacted directly by Harbinger Health's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Harbinger Health, and Harbinger Health will not owe any referral or other fees with respect thereto.