Senior Manager, Reagent Manufacturing & QC

Location: On-site, 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 Laboratory Manager, Production at Foresight Diagnostics plays a pivotal role in overseeing the daily operations of our Production laboratory; supporting both clinical and translational research functions. Reporting directly to the Site Lead, this position is responsible for managing personnel, optimizing workflows, ensuring compliance with regulatory standards, and fostering a culture of excellence and innovation within the laboratory environment for the shifts assigned. The Laboratory Manager, Production will collaborate closely with cross-functional teams to drive operational efficiency and uphold the highest standards of quality in cancer diagnostics. A successful candidate will possess a strong blend of technical expertise, leadership skills, regulatory knowledge, and practical experience in laboratory operations. This is a full-time onsite position with the possibility of flexible working hours, including evenings, weekends, and holidays, as needed to support laboratory operations.

What You Will Do:

• Operational Management: Overseeing day-to-day laboratory operations, including testing procedures and result reporting, to ensure timely and accurate delivery of results for the assigned shifts.

• Personnel Management: Recruiting, hiring, training, and supervising testing production laboratory staff, as well as providing ongoing support, coaching, and performance evaluation.

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

• Workflow Optimization: In concert with the Site Lead, developing and implementing efficient laboratory workflows and protocols to maximize productivity, minimize turnaround times, and optimize resource utilization.

• Cross functional Partnership: Participate in and drive cross functional communication, planning, and execution strategies to enable streamlined clinical and translational research testing operations and advancements with the goal of improved outcomes for patients and clients.   

• Quality Assurance and Compliance: In collaboration with the Laboratory Director and the Site Lead, ensure compliance with regulatory standards, including CLIA, CAP, FDA, GxP and other applicable regulations, by maintaining accurate records, performing quality control procedures, and participating in proficiency testing programs and audits.

• Instrumentation and Equipment Management: Overseeing the day to day maintenance, calibration, and troubleshooting of laboratory instruments and equipment to ensure optimal performance and reliability. Serve as the first line of defense when issues impacting operations occur.

• Inventory Management: In collaboration with the Supply Chain department, support management of laboratory supplies, reagents, and consumables inventory to ensure adequate stock levels, minimize waste, and prevent delays in testing.

• Safety and Environmental Management: Implementing and enforcing safety protocols, procedures, and regulations to protect laboratory staff, patients, and the environment from potential hazards and ensure compliance with OSHA and other safety standards.

• Customer Service and Communication: Interfacing with external partners to address inquiries, provide support, and ensure a high level of clinical and translational research customer satisfaction.

• Continuous Improvement: Identifying and escalating opportunities for process improvement, quality enhancement, and cost optimization through ongoing evaluation, benchmarking, and implementation of best practices.

• Training and Education: Providing ongoing training, education, and professional development opportunities for laboratory staff to enhance their skills, knowledge, and performance.

• Wet Lab Testing: Maintain proficiency in wet lab processes to provide testi