Supervisor, Molecular Laboratory - Cambridge, United States - Foundation Medicine

Description

Job Description

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.

#On-site


About Us

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)