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Scientist II, Reagent Manufacturing

Location: Onsite in Boulder, Colorado 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. Reporting to the Senior Director, Regulated Assay Development, this position requires a flexible and collaborative self-starter with extensive experience designing, executing, analyzing, and interpreting complex, multi-factorial experiments. You will be developing and transferring reagent test methods, implementing process improvements, and supporting products in our CLIA lab to ensure they meet quality and regulatory requirements. This will involve conducting laboratory studies to develop, improve, and troubleshoot, as well as cross-training operators to support technology transfer into a production setting. This role will provide the opportunity to work cross-functionally with many different departments, including operations, supply chain, quality, automation engineering, regulatory, and bioinformatics teams, among others. Ideal candidates for this position are dedicated team players, capable of assisting with several projects at once, who can be a part of a strong collaborative team and with an ability to build strong working relationships with multiple and diverse teams. What You Will Bring

B.S. or M.S. with 5+ years of industry experience, or Ph.D. with 2+ years of industry experience in Molecular Biology, Biochemistry, Bioengineering, Chemistry, or a related field. Experience in DoE (Design of Experiments) based design and optimization preferred. Strong technical background and hands-on experience in molecular biology techniques, including DNA/RNA purification and quantification, PCR/qPCR, molecular cloning, enzymatic assays, protein engineering, and Next Generation Sequencing (NGS) techniques. Track record in late product development/support and prior experience in biotech manufacturing or technical transfer, within FDA regulated, CAP/CLIA, and ISO13485 environments. Deep knowledge and hands-on experience with next-generation sequencing (NGS) library preparation and Illumina sequencers (or other sequencing platforms) preferably using robotic liquid handlers. Excellent problem-solving skills for dissecting the role of process versus equipment or reagents are critical for this role to determine the root cause of issues occurring during complex workflows. Proficiency in managing large data sets and data analysis tools, such as Excel, JMP, R, Python etc. Good work ethic with a "can-do" mentality and attitude for approaching challenging questions. Dynamic interpersonal skills. Respectful and open to others' views; contribute to building a positive team spirit. Self-motivated, willing to learn and be up to date on current scientific literature or new research developments. What You Will Do

Work under design controls and support design and development, verification and validation, manufacturing, and testing of In Vitro Diagnostic (IVD) medical devices in accordance with ISO13485 and FDA guidelines. Develop of manufacturing processes, stability and processing equipment for buffers, enzymes, mixtures, and/or raw materials with unique physical or chemical attributes incorporating industry standard techniques at both small and large scale. Work with external vendors, clinical, bioinformatics and assay development teams to develop specifications for testing and manufacturing reagents and execute routine testing methods for quality testing and release of highly complex reagents. Execute process development, training, and pilot scale manufacturing for moderate and complex processes/products. Coordinate with the clinical lab for inventory/ batch planning and further support production operators in troubleshooting issues that arise during manufacturing. Work with multi-disciplinary teams for developing and executing experimental and analytical strategies to troubleshoot, develop, and improve processes. Support investigations for non-conformances and deviations using appropriate investigation tools (Ex. Fish bone diagram, 5 Whys) and implement corrective actions that will prevent the recurrence of various workflow issues in accordance with the Quality System Nonconformance/CAPA and Change Management procedures. Support process and test method validation readiness and execution including bridging studies to support post-launch workflow improvements/changes. Responsible for maintaining accurate records and leading/supporting completion of deliverables such as project plans, SOPs, change orders, batch records, and technical reports. Identify the design defects and process failure modes, conduct risk assessments and manage risk through proper mitigation measures. Support and comply with the company's quality management system policies and procedures. Train and mentor junior scientists or associates on processes including experimental design, execution, analysis, troubleshooting, and review of new methods, to facilitate process improvements and the transfer of new methods. 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 close visual acuity to perform an activity such as: preparing and analyzing data and figures, writing and reviewing documents, and pipetting small volumes of clear liquids. This is an essential position supporting clinical laboratory operations requiring attendance on weekends, holidays, and during emergency conditions, such as inclement weather and power failure. This position requires the ability to identify and resolve quality issues. This position is a full-time, in-person position in Boulder, CO. Compensation & Benefits

This role is hiring at an annual salary between $123,000 - $132,600 and is eligible for bonus and equity offerings. Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.