Senior Manager, Production Laboratory

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 Senior Manager, Production Laboratory 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. The Senior Manager, Production Laboratory 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.

Responsibilities

• Operational Management: Overseeing day-to-day laboratory operations, including testing procedures and result reporting, to ensure timely and accurate delivery of results.
• 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.
• 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 testing support, if/when needed and to ensure quality and efficacy of laboratory training programs.
• Emergency Response and Crisis Management: Developing and implementing contingency plans and protocols to address emergencies, equipment failures, or other unforeseen events that may impact laboratory operations or patient care.
• This position has direct supervisory responsibilities.

Skills and Qualifications

• Bachelor's degree (BA/BS) in a relevant scientific field such as biology, chemistry, medical technology, laboratory management or a related discipline required; advanced degree (Ph.D. or Masters) preferred. Certification as a Medical Laboratory Scientist (MLS), Clinical Laboratory Scientist (CLS), or equivalent certification preferred.
• Minimum of 5 years of experience in people leadership roles within laboratory and operations environments.
• Excellent leadership, team management, and interpersonal skills with the demonstrated ability to lead and manage a diverse team of laboratory professionals, influence cross functional teams, and operate as a change champion.
• Demonstrated ability to build rapport with cross functional leaders to enable delivery to shared goals and objectives.
• Proficiency in a wide range of laboratory techniques and procedures relevant to high complexity testing, including molecular biology and chemistry.
• Experience with the operation, maintenance, and troubleshooting of laboratory instruments and equipment used for high complexity testing.
• Knowledge of quality control principles and practices, including the implementation and interpretation of quality control procedures, proficiency testing, and documentation requirements
• Ability to analyze and interpret laboratory data, identify trends or deviations, and take appropriate corrective actions as needed.
• Understanding of CLIA regulations and guidelines, ISO15189, as well as other relevant regulatory requirements such as FDA regulations, Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) requirements.
• Demonstrated ability to lead and manage a diverse team of laboratory professionals, including hiring, training, performance management, and fostering a culture of collaboration and excellence.
• Excellent organizational skills with experience in laboratory workflow optimization.
• Ability to implement strategic plans, goals, and objectives for the laboratory, aligning with the organization's mission and objectives.
• Self-starter with the ability to thrive in a fast-paced, ambiguous environment and deliver projects autonomously.

This role is offering a salary between $125,000-140,000 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 August 15, 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.