Supervisor, Molecular Laboratory (Sun-Thurs, 3rd Shift) - Cambridge Massachusetts

Company: Disability Solutions
Location: Cambridge, Massachusetts
Posted On: 04/21/2024

About the Job
The Supervisor of the Molecular Laboratory manages a team of direct reports and embodies thecompany's values in all aspects of managing laboratory personnel. The Supervisor of the MolecularLaboratory is a decision maker for questions and is a highly trusted team member for all laboratorypersonnel. This role spends significant time collaborating cross-site and cross-functionally to ensureefficient workflow. The incumbent in this position may be assigned to work any day that the lab isoperational and requires working in a lab environment using chemicals and reagents. Titles are internalto Foundation Medicine and may not align with Clinical Regulations.
This is a regulated position and additional information may be available from FMI Quality Assuranceregarding 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 standardoperating procedures and regulatory standards of CLIA, FDA, and CAP.---Manage laboratory personnel by preparing schedules for incoming shift to ensure competent personnelare 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 ensureadherence 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 otherdepartments.---Be on the on-call rotation for the molecular lab supervisors hotline to troubleshoot any issue that come upon site.---Maintain flexibility to cover scheduling gaps as needed and to be included in the on-call rotation foradditional 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 thatmay 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 methodevaluation, 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 proficiencybenchmarking 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 forwardand reviewing and/or writing non-conformance reports, deviations, CAPAs, and incident reports asneeded in compliance with QMS system.---Collaborate with internal teams, vendors, and others as needed to resolve issues, maintain ongoingfunctionality and document service, project management and repair work.---Participate on cross-functional teams to coordinate troubleshooting and process improvements, and/orimplement new workflows or products.---Assist in preparing for, performing and responding to internal and external audits as well as any otherinspections.---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 ofexperience in a molecular clinical laboratory (CLIA/CAP); OR,--- (b) Bachelor's of Science Degree in Medical Technology and 6+ years of experience in amolecular clinical laboratory (CLIA/CAP); OR,--- (c) Masters' of Science Degree in Chemical, Physical or Biological Science and 4+ years ofexperience in a molecular clinical laboratory (CLIA/CAP), at least 2 of which have been spentworking 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, andsequencing 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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