About the Job

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 Supervisor of the Molecular Laboratory is a decision maker for questions and is a highly trusted team member for all laboratory personnel. This role spends significant time collaborating cross-site and cross-functionally to ensure efficient workflow. The incumbent in this position may be assigned to work any day that the lab is operational and requires working in a lab environment using chemicals and reagents. Titles are internal to Foundation Medicine and may not align with Clinical Regulations.

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.

Key Responsibilities

• Manage laboratory process 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 shift 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 ensure adherence to PPE guidelines.

• Establish 1:1 with direct reports and provide coaching and development.

• Respond to general inquiries such as sample, plate or process inquiries from Client services and other departments.

• Be on the on-call rotation for the molecular lab supervisors hotline to troubleshoot any issue that come up on site.

• Maintain flexibility to cover scheduling gaps as needed and to be included in the on-call rotation for additional weekend and/or holiday technical support.

• Review Batch Records to ensure it is released to QA on time.

• Review Daily Management Board to ensure countermeasure are set and reviewed for any issues that may have come up 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 QMS system.

• Collaborate with internal teams, vendors, and others as needed 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.

• Titles are internal to Foundation Medicine and may not align with Clinical Regulations.

Qualifications

Basic Qualifications

• One of the three 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) Masters’ of Science Degree in Chemical, Physical or Biological Science and 4+ years of experience in a molecular clinical laboratory (CLIA/CAP), at least 2 of which have been spent working under the direction of a doctoral level supervisor

• Certifications or licensure that is required by the state or country in which the job is posted

• 2+ years of leadership experience

Preferred Qualifications

• Strong experience working in QSR compliant lab or other regulated laboratory environment

• Knowledge and experience working with DNA manipulation techniques, enzymatic reactions, and sequencing chemistry

• Experience with ensuring and maintaining integrity and quality of a lab in compliance with QMS

• Experience with a Laboratory Information Management System (LIMS)

• Demonstrated history working as a leader within a team

• Knowledge of accreditation and regulatory standards

• Knowledge of laboratory safety protocols

• Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.)

• Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point

• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues

• Excellent organization and attention to detail

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

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