Supervisor, Molecular Laboratory

Overview

The Supervisor of the Molecular Laboratory manages a team of direct reports and embodies the company’s values in all aspects of managing laboratory personnel. The role is a decision maker for questions and a highly trusted team member for all laboratory personnel. This position spends significant time collaborating cross-site and cross-functionally to ensure efficient workflow. The incumbent may be assigned to work any day the lab is operational and requires working in a laboratory environment using chemicals and reagents.

This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines. Regular onsite work at a designated FMI location is an essential function of this role. Titles are internal to Foundation Medicine and may not align with Clinical Regulations.

• Manage laboratory processes to ensure day-to-day operations are in compliance with internal standard operating procedures and regulatory standards of CLIA, FDA, and CAP.
• Manage laboratory personnel by preparing schedules for incoming shifts to ensure competent personnel are scheduled and prioritize work in progress to meet turnaround time (TAT).
• Demonstrate commitment to maintaining TAT objectives, quality, and continuous improvement.
• Perform lab walkthroughs to review maintenance logs, lab cleanliness, waste management and adherence to PPE guidelines.
• Establish one-to-one meetings with direct reports and provide coaching and development.
• Respond to general inquiries from Client services and other departments about samples, plates or processes.
• Be on the on-call rotation for the molecular lab supervisors hotline to troubleshoot issues on site.
• Maintain flexibility to cover scheduling gaps as needed and participate in the on-call rotation for weekend and/or holiday technical support.
• Review Batch Records to ensure release to QA on time.
• Review Daily Management Board to ensure countermeasures are set and reviewed for any issues in the lab.
• Support all operational aspects of quality assurance and quality control.
• Hire and onboard new Technologists.
• Contribute to the maintenance or development of technical and analytical standards for method evaluation, development of quality improvement initiatives, and evaluation of new instrumentation, analytical methods and laboratory procedures.
• Act as decision maker on tactical issues operationally and systemically on designated shift.
• Provide training, competency evaluation, protocol compliance management and annual proficiency benchmarking of all laboratory personnel.
• Leverage a deep understanding of the process in troubleshooting assays and instrumentation as needed.
• Investigate and problem solve laboratory and department incidents, including driving the process forward and reviewing and/or writing non-conformance reports, deviations, CAPAs, and incident reports as needed in compliance with the QMS system.
• Collaborate with internal teams, vendors, and others to resolve issues, maintain ongoing functionality and document service, project management and repair work.
• Participate on cross-functional teams to coordinate troubleshooting and process improvements, and/or implement new workflows or products.
• Assist in preparing for, performing and responding to internal and external audits as well as any other inspections.
• Represent the laboratory operations department at cross-functional meetings or to guests as needed.
• Review and write standard operating procedures as needed.
• Continue building a cohesive team.
• Other duties as assigned.
• Qualifications/Title note:
  Internal to Foundation Medicine and may not align with Clinical Regulations.

• One of the education or experience combinations:
• (a) Bachelor’s of Science Degree in a chemical, physical or biological science and 7+ years of experience in a molecular clinical laboratory (CLIA/CAP); OR
• (b) Bachelor’s of Science Degree in Medical Technology and 6+ years of experience in a molecular clinical laboratory (CLIA/CAP); OR
• (c) Master’s of Science Degree in Chemical, Physical or Biological Science and 4+ years of experience in a molecular clinical…