Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Supervisor, Lab Process - Extraction

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Supervisor, Laboratory Process supervises operations of the laboratory. In particular, the position provides support to Molecular Technicians and Technologists at their location through activities including advanced troubleshooting, the development and execution of training plans, and continuing education. The Supervisor, Laboratory Process is responsible for ensuring equipment maintenance and for process improvement initiatives with the primary goal to ensure sample processing is appropriately resourced and scheduled to meet operating goals and result Turn Around Time (TAT). Titles are internal to Foundation Medicine and may not align with Clinical Regulations.

Supervisors, Laboratory Process are assigned to a shift and may be assigned to adjust hours or work any day that the lab is operational.

This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities

• Supervisory:

• Oversee day to day operations of the pre-lab work centers Extraction and Library Construction.

• Serve as a technical resource for Technicians and Technologists:

  • Provide troubleshooting support.
  • Develop and execute training plans and continuing education.
  • Ensure approved solutions and reagents are prepared and available for processing.
  • Provide on the job training as needed.
  • Support competency assessments to ensure laboratory staff are adhering to protocols for their work center.

• Communicate training and competency assessment needs for work center.

• Support the lab management with maintaining and publishing the lab schedule.

• Generate content for lab staff meetings.

• Responsibilities of Batch records:

• Oversee the accuracy of the electronic batch records and hand-written batch records submitted by the technologist.

• Ensure that the batch records are submitted to QA on time to maintain TAT.

• Counsel Technologists on Good Documentation Practice.

• Initiate and submit INC/NCRs to QA.

• Operational Responsibilities:

• Communicate and escalate issues and delays effectively to necessary personnel.

• Conduct sample tracking and respond to internal client services status inquiries.

• Lead process improvement initiatives.

• Ensure equipment is in functioning order and down time is minimized.

• Collect, maintain and publish operational metrics per work center to ensure sample processing is appropriately resourced and scheduled to meet operating goals and result Turn Around Time (TAT).

• Support the evaluation of new instrumentation, analytical methods, and laboratory procedures.

• Perform daily, weekly, monthly and as needed equipment maintenance checks.

• Write, collaborate, revise and review Standard Operating Procedures (SOPs) annually and as needed to adjust for process improvement initiatives and regulatory changes.

• Compliance Responsibilities:

• Document and assist with investigations for non-compliance events via Non-Conformance Reports, Corrective Action Preventative Actions, etc.

  • Utilize established Quality Management System (QMS) for documenting these events, as needed.

• Provide support for audit activities.

• Support review of records to ensure quality, compliance and adherence to Comprehensive Genomic Profiling (CGP).

• Manage the deployment of temporary deviations as needed.

• Maintain efforts for compliance with laboratory safety protocols.

• Other Responsibilities:

• Establish a deep understanding of the process to troubleshoot assays and instrumentation as needed.

• Lead user testing and requirements gathering to provide feedback for LIMS workflows and software releases.

• As needed:

  • Perform highly complex testing according to established SOPs (NGS library prep, hybridization, and sequencing).
  • Operate automated 8-span and 96-head liquid handling platforms for sample processing.
  • Operate quantification, sizing, and NGS instruments.
  • Liaise with other departments for updates on cross functional projects and initiatives.
  • Respond to more advanced laboratory operational problem solving, acting as trusted “go to” person for all questions, complex or simple.
  • Complete projects fitting of level of expertise and be able to deliver results with minimum guidance.

• Additional project-based work as it pertains to improving the process or providing system requirements in laboratory work center.

• Other duties as assigned.

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

Qualifications

Basic Qualifications

• Bachelor’s degree in a biological, chemical, physical, or life science

• 6+ years of relevant lab experience in a CLIA/CAP regulation-adherent lab

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

Preferred Qualifications

• Familiarity with Laboratory Information Management System (LIMS)

• A high level of experience and knowledge of FMI’s complex NGS laboratory

• Quality management experience and experience with ensuring and maintaining integrity and quality of the lab (sample processing, equipment, QMS)

• Experience writing SOPs and guidelines in the regulated environments referenced above

• Previous experience in managing or leading a process

• 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

• Knowledge of and experience with Oncology

• Ability to:

  • work well under pressure while maintaining a professional demeanor
  • prioritize and thoroughly follow up on assigned tasks
  • handle multiple tasks at once and work in a fast-paced environment
  • adapt to changing procedures, policies and work environment
  • work within a highly complex clinical diagnostic laboratory environment within the presence of chemicals and reagents
  • work any day and shift that the laboratory is operational

• Understanding of HIPAA and importance of patient data privacy

• Demonstrated integrity and a commitment to values held at FMI: patients, innovation, collaboration, and passion

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

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.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Internal applicants, please use your FMI email address.

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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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