Principal Scientist, Regulated Assay Development

Job Title: Principal Scientist, Regulated Assay Development

Location: On-Site in Boulder, Colorado, United States

About our Company

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role

The Regulated Assay Development group plays a central role at Foresight, engaging at the interface of science, engineering, and operations, to deliver game-changing MRD detection technologies. We are looking for a flexible and collaborative self-starter with extensive experience designing, executing, analyzing, & interpreting complex, multi-factorial experiments. Strong troubleshooting skills, critical thinking, and attention to detail are essential. The right candidate will enthusiastically leverage their experience, curiosity, and creativity to collaborate & innovate in areas of assay development, reagent manufacturing, and data management.

What You Will Bring

• B.S., M.S., or Ph.D. in Molecular biology, Biochemistry, Bioengineering, Chemistry, or a related field.

• 13+ years of industry/ post baccalaureate academic experience.

• Demonstrated record of innovation developing molecular biology assays and techniques.

• Proven ability to work collaboratively on cross-functional teams in a highly dynamic environment.

• Exceptional data analysis skills, with strong analytical abilities and attention to detail.

• Familiarity with regulatory requirements for assays with different types of risk profiles.

• Understanding of the steps of the product development process and the importance of managing risk in product development.

• Mastery of common molecular techniques/NGS library preparation and comfort with working in the lab as needed.

• Proven ability to troubleshoot complex technical issues.

• Comfortable making decisions that impact the direction of a project.

• Significant experience creating figures, data visualizations, written protocols and/or presentations that clearly communicate complex scientific information and concepts for a broad audience.

• Ability to learn quickly and willingness to work determinedly at a dynamic start-up company.

• Familiarity with one scripting language such as R or Python is a plus.

What You Will Do

• Design strategies and technology-driven proposals to optimize product development while demonstrating creativity in problem-solving.

• Execute complex, information-rich experiments that provide decisive development direction.

• Work collaboratively with cross-functional teams on product development deliverables, identifying failure modes, or improving assay performance.

• Create and manage timelines for assay development deliverables.

• Provide technical input to support cross functional deliverables such as trace matrices and failure modes & effects analyses.

• Streamline processes to enhance efficiency and accelerate productivity of the team.

• Drive root cause and permanent corrective actions to resolve issues as they arise.

• Conduct detailed data analyses, use bioinformatic pipelines, and provide data-driven recommendations.

• Keep meticulous and consistent documentation of all work performed or overseen in compliance with Good Laboratory Practices and Quality Systems.

• Transfer new methodologies and assays from Assay Development to Reagent Manufacturing and/or Operations.

• Provide clear and concise written and oral communications to colleagues and supervisors.

• Provide technical mentorship to junior team members.

Physical Requirements

• This position requires the individual to wear and work in personal protective equipment.

• This position requires the ability to lift a minimum of 25lbs.

• Substantial movements (motions) of the wrists, hands, and/or fingers are required.

• Required to have clo