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.

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

The expected salary range for this position based on the primary location of Boston, MA is $103,500 –$122,000per year. The salary range is commensurate with FMI’s compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for FMI benefits.

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