Site Lead, Laboratory Operations

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Job description

Site Lead, Laboratory Operations

Location: Onsite in Boulder, CO

About the 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 Site Lead at Foresight Diagnostics will be responsible for oversight of laboratory operations and testing at Foresight's Boulder, Colorado facility and will collaborate to integrate cross functional laboratory requirements to deliver operational quality and efficiency that meets all regulatory guidelines for Foresight's breadth of laboratory testing. The Site Lead will hold certifications such that they could perform testing in the CLIA laboratory (including patient samples from California and New York) and receive delegation authority from Foresight's Laboratory Director. This is an advanced level role that would suit an experienced leader who has managed cross functional laboratory teams processing high-complexity NGS based testing through all phases of the business life cycle. This is a full-time position based in Colorado working standard business hours in a startup company, that will require the flexibility to work diverse schedules, including evenings, weekends, and holidays for critical deliverables. This position reports to the SVP, Business and Laboratory Operations and Strategy.

What You Will Do:

• Provides onsite operational leadership to Foresight's laboratory teams through the integration of operational wet lab processes and is responsible for building efficient and high quality laboratory workflows and protocols that maximize productivity, minimize turnaround times, and optimize resource utilization.

• Maintain proficiency in wet lab processes to provide testing support, if/when needed and to ensure quality and efficacy of laboratory training programs.

• Stakeholder in the development and technical transfer of new products (assays, automation, software, etc.) to the production environment with the goal of successful operational implementation and product launch, revenue enhancement, cost expense reduction, and efficient, high quality testing.

• Oversees resource allocation including space, capital equipment, scientific instrumentation and staff for the Boulder, CO facility operating as the authority among functional leadership.

• Responsible for laboratory adherence to quality standards and policies as it relates to laboratory operations and regulations (GxP, CAP/CLIA, NYSDOH, ISO15189)

• Collaborate with the Director of Supply Chain on S&OP to ensure ability to meet regulated and translational research study schedules, clinical testing TAT requirements, and internal deadlines.

• Collaborate with Directors of Research, Development, Software and Bioinformatics to align on product requirements and implementation/tech transfer plans to enable launch of new products into production.

• In collaboration with the SVP, Business and Laboratory Operations and Strategy, establish and track applicable laboratory metrics/key performance indicators to inform senior leadership on the health of laboratory operations.

• Partner with Medical Affairs and Clinical Operations teams to implement defined processes to execute RFPs, clinical trials, and biobanking.

• Participate in external communication with customers on translational research project kick off and subsequent status, QC results, delivery timeline, study results, etc. with a goal of maintaining a high standard of customer satisfaction.

• Assist the Quality team and Laboratory Director with internal and external audits, and operate as the operations lead/POC for the production laboratory with an escalation path to the SVP, Business and Laboratory Operations and COO.

• Establish and maintain strong working relationships with cross functional leads to develop proactive communication mechanisms and support successful execution of integrated quarterly and yearly objectives.

• Oversee, plan, and implement quality checks for laboratory testing and provide leadership and direction to ensure the highest standards for compliance.

• Troubleshoot technical and operational problems as they affect the laboratory, escalating to senior leadership when necessary.

• Ensure training and competency policies and SOPs are followed for hiring and monitoring individuals who conduct testing to ensure they have the appropriate education and experience, are competent, and maintain their competency to perform testing procedures.

• Operate as a Change Ambassador facilitating implementation of strategic and operational decisions that enable execution of corporate objectives and goals.

• Recruit, retain, train, and develop employees and conduct performance management activities. Develop a team-oriented culture within and between departments.

• This position has direct supervisory responsibilities.

What You Will Bring:

• 8+ years leading transformative change in multi-departmental laboratory and operations environments.

• A bachelor's degree: BA/BS. An advanced degree, such as a Ph.D. or Masters degree preferred with proficiency in and leadership of a clinical laboratory providing real time NGS testing.

• Experience in scaling operations from early stage to higher demands due to significant growth in a regulated environment (GxP, CAP/CLIA, NYSDOH, ISO15189).

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

• Self-starter with the ability to deliver on end-to-end projects with a high level of autonomy and a proven ability to deliver actionable results to complex problems.

• Demonstrated ability to recruit quality talent and lead high performing teams.

• Strong driver and influencer who can motivate, drive consensus, and deliver results among cross functional stakeholders/teams.

• Comprehension of general finance and budgeting principles, enabling sound financial decision-making as it relates to scaling and capacity planning.

• Exceptional communication aptitude, encompassing the ability to convey ideas and information with clarity and precision.

• Proven track record of achieving and sustaining excellence in quality, service, and client interactions, particularly within fast-paced environments.

• Foster an organizational culture of accountability, quality, and continuous improvement within a regulated operating environment.

This role is offering a salary between $185,000-235,000 and is eligible for 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.

The application deadline for this position is November 29, 2024.

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.

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