Technical Supervisor (Tues-Sat 3rd Shift) at Foundation Medicine, Inc. in Cambridge, Massachusetts

Job Description:

About the Job

The Technical Supervisor on the Molecular Team manages a small team of direct reports and embodies the company's values in all aspects of managing laboratory personnel. This position performs patient sample testing, equipment maintenance, solution and reagent preparation in addition to other tasks in a highly complex clinical diagnostic laboratory. The Technical Supervisor 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, providing guidance and direction.
• 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.
• Perform highly complex testing according to established standard operating procedures (histology, DNA/RNA isolation, NGS library prep, hybridization, and sequencing).
• Leverage a deep understanding of the process in troubleshooting assays and instrumentation as needed.
• Order reagents and consumables.
• Track samples progress and respond to sample progress inquiries from Client Services and other departments as needed.
• Support all operational aspects of quality assurance and quality control.
• Investigate and problem solve laboratory and department incidents, including driving the process forward, reviewing and/or writing non-conformance reports, deviations, CAPAs, and incident reports as needed in compliance with QMS system.
• Contribute to maintenance of equipment and other technical resources.
• Collaborate with internal teams, vendors, and others as needed to resolve issues, maintain ongoing functionality and document service, project management and repair work.
• Assist in preparing for, performing and responding to internal and external audits as well as any other inspections.
• Represent laboratory operations department at cross functional meetings or to guests as needed.
• Demonstrate commitment to maintaining TAT objectives, quality, and continuous improvement.
• Review and write standard operating procedures as needed.
• Participate on cross functional teams to coordinate trouble shooting, process improvements, and/or implement new workflows or products.
• 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.
• 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

Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement . If you have a disability or special need that requires accommodation, please let us know by completing this form . (EOE/AAP Employer)

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