Director, Reagent Manufacturing & QC

Job Title: Director, Reagent Manufacturing & QC

Location: Onsite in Boulder, CO

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 Director, Reagent Manufacturing & QC is responsible for designing, developing, implementing, and maintaining scalable and compliant reagent manufacturing methods and quality control processes for Foresight’s research, development, and clinical laboratories. This role will lead cross functional collaboration to integrate business, quality, regulatory, laboratory operations, and product requirements into high-functioning reagent manufacturing and quality control operations that support Foresight’s product life cycle and growth across clinical and commercial programs.

The ideal candidate is a strategic thinker and experienced builder who thrives in fast-paced, evolving environments and brings strong systems-level thinking with a track record of successful method development, process implementation, and cross-functional alignment. This position will support a team of Reagent Manufacturing and QC management and specialists to successfully manufacture high-quality reagents to meet business and regulatory requirements for all intended uses, implement process improvements driven by key stakeholders, and support troubleshooting and supplier quality requirements. This is a full-time position working standard business hours, but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the SVP, Business and Laboratory Operations and Strategy.

What You Will Do

• Architect and implement reagent manufacturing methods and systems that support high-throughput, high-complexity testing in compliance with CAP/CLIA, CLEP, GxP and FDA requirements through the creation of reagent operations strategy and roadmap including required CapEx, facilities strategy, organization, regulatory impact, and business processes.

• Build, mentor, and lead a high-performing team responsible for internal reagent manufacturing and quality control for the full life cycle of Foresight’s products, implementation of process improvements or new reagents/products, support quality control troubleshooting all while meeting supplier quality and regulatory requirements. Ensuring the group operates as a strategic partner to R&D, Laboratory Operations and Laboratory Services teams.

• Collaborate with stakeholders in PMO, R&D, Clinical, Operations, Quality, Regulatory, and Product to define and execute on technical and operational requirements for new products, programs and workflows.

• Co-lead implementation of reagent manufacturing on automated platforms with the Director, Laboratory Automation Engineering. Translating business requirements into functional specifications and scalable system designs.

• Partner with Supply Chain, R&D, Laboratory Operations, and Laboratory Services to manage seamless support of high complexity testing as demand scales quarter over quarter through strategic planning to ensure materials and volumes are available to support timely execution of regulatory studies, research, translational medicine, and clinical commercial testing.

• Define and oversee departmental key performance indicators (KPIs), dashboards, and metrics to drive transparency, efficiency, and continuous improvement through monitoring. Driving recommendations for process change as an outcome of data-informed decisions.

• Ensure effective resource utilization, planning and execution of people, process, and products in alignment with corporate objectives and volume projections across cross-functional teams.

• Guide troubleshooting and resolution of incident reports and CAPAs while driving continuous improvement.

• Ensure compliance with ISO 13485, successful annual audits and recertifications

• In collaboration with the Reagent Manufacturing & QC management, develop processes for manufacture, quarantine, verify and release of reagents, lot tracking.

• Partner with Regulated Assay Development to define test method validations, complete data analysis, and draft validation reports to meet applicable regulatory standards.

What You Will Bring

• Bachelor’s degree in Life Sciences, Engineering, or related field required; advanced degree preferred.

• 8+ years of experience in reagent manufacturing for clinical diagnostics or life sciences with a focus on laboratory systems, operations engineering, and process implementation.

• 3+ years of experience in a formal people management and technical leadership role.

• Experience developing ISO13485 compliant reagent manufacturing for multi-site operations.

• Hands-on experience in quality control, molecular biology, and/or clinical laboratory testing (NGS preferred) and technical understanding of quality control as it relates to CAP/CLIA and FDA regulated environments.

• Demonstrated experience of manufacturing with automation, such as Hamilton STAR/STARlet and Agilent Bravo preferred.

• Strong understanding of regulated environments including CAP/CLIA, GxP, FDA, and applicable standards.

• Excellent cross-functional communication and project management skills.

• Proven ability to operate effectively in a dynamic, high-growth environment with competing priorities while meeting timelines on budget.

• Ability to think critically to overcome hurdles and devise solutions.

• Advanced analytical and operational skills with an ability to identify meaningful insights from complex data.

Physical and Mental Requirements, Working Conditions

• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This position requires close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

• Work is performed in an office environment and requires the ability to operate standard office equipment and keyboards. Must have the ability to walk short distances, and/or drive a vehicle to deliver and pick up materials.

• 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 and Benefits

This role is hiring at an annual salary of $190,000 - $240,000 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.