Senior Manager, Production Laboratory

$125,000 - $140,000/Yr

Foresight Diagnostics - Boulder, CO

Full-time - Mid Level

Boulder, CO

About the position

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

• Overseeing day-to-day laboratory operations, including testing procedures and result reporting, to ensure timely and accurate delivery of results.
• Recruiting, hiring, training, and supervising testing production laboratory staff, as well as providing ongoing support, coaching, and performance evaluation.
• Facilitating implementation of strategic and operational decisions that enable execution of corporate objectives and goals.
• Developing and implementing efficient laboratory workflows and protocols to maximize productivity, minimize turnaround times, and optimize resource utilization.
• Participating in and driving cross functional communication, planning, and execution strategies to enable streamlined clinical and translational research testing operations and advancements.
• Ensuring 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.
• Overseeing the day to day maintenance, calibration, and troubleshooting of laboratory instruments and equipment to ensure optimal performance and reliability.
• Supporting management of laboratory supplies, reagents, and consumables inventory to ensure adequate stock levels, minimize waste, and prevent delays in testing.
• Implementing and enforcing safety protocols, procedures, and regulations to protect laboratory staff, patients, and the environment from potential hazards.
• Interfacing with external partners to address inquiries, provide support, and ensure a high level of clinical and translational research customer satisfaction.
• Identifying and escalating opportunities for process improvement, quality enhancement, and cost optimization through ongoing evaluation, benchmarking, and implementation of best practices.
• Providing ongoing training, education, and professional development opportunities for laboratory staff to enhance their skills, knowledge, and performance.
• Maintaining proficiency in wet lab processes to provide testing support, if/when needed and to ensure quality and efficacy of laboratory training programs.
• Developing and implementing contingency plans and protocols to address emergencies, equipment failures, or other unforeseen events that may impact laboratory operations or patient care.

Requirements

• 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.
• 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.

Nice-to-haves

• Certification as a Medical Laboratory Scientist (MLS), Clinical Laboratory Scientist (CLS), or equivalent certification preferred.

Benefits

• Paid vacation
• Sick time
• Parental leave (if applicable)
• Medical coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability coverage
• Flexible spending accounts
• 401k with company match