Staff Scientist, Reagent Manufacturing

Job Title: Staff Scientist, Reagent Manufacturing

Location: Onsite in Boulder, Colorado

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. The Staff Scientist, Reagent Manufacturing position

Reporting to the Senior Director, Regulated Assay Development, this position requires a flexible and collaborative self-starter with extensive experience designing, executing, analyzing, & 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., M.S., or Ph.D. in Molecular biology, Biochemistry, Bioengineering, Chemistry, or a

• related field.

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

• Experience in DoE (Design of Experiments) based design and optimization.

• 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.

• Strong background in molecular biology techniques, including DNA/RNA purification and quantification, PCR/qPCR, molecular cloning, enzymatic assays, protein engineering, and Next Generation Sequencing (NGS) techniques.

• 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.

• Lead the development 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.

• Works 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 devel