Sr. Laboratory Technologist: Tuesday - Saturday (9am - 5pm) in Morrisville, North Carolina at Foundation Medicine, Inc.

About the Job:

The Sr Laboratory Technologist, Lab Operations Product Implementation supports initiatives that enable running, enabling, and onboarding RUO products and Orthogonal Testing in the small-scale FMI Laboratory. Candidates should be highly motivated, able to think creatively, confident with multi-tasking and attentive to details. This position serves as a technical resource, performs wet-bench testing and may perform patient sample testing in the clinical testing laboratory to maintain testing personnel compliance as required. This position is responsible for troubleshooting in the lab, equipment maintenance, solution and reagent preparation for RUO needs, process improvement initiatives, sample tracking and responding to internal partner inquiries.

Senior Laboratory Technologists, Lab Ops Product Implementation are assigned to a shift and may be assigned to adjust hours or work as required based on business initiative need.

This is an onsite essential role, regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities:

• Lab Responsibilities:
  • Perform sample testing for RUO and internal Orthogonal Testing that adheres to all established standard operating procedures (SOPs) and facilitate communication and smooth transition of specimens between steps.
  • May perform clinical testing in the clinical lab as required.
  • Communicate and escalate issues and delays effectively to necessary personnel.
  • Conduct sample tracking and respond to internal partner status inquiries.
  • Lead process improvement initiatives.
  • Ensure equipment is in functioning order and down time is minimized.
  • 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.
  • Document and assist with investigations for lab incidents.
  • Utilize established Quality Management System (QMS) for documenting these events, as needed.
  • Maintain compliance with competency assessment program, including proficiency testing and alternative assessment program.
  • Maintain required Continuing Education credits.
  • Maintain efforts for compliance with laboratory safety protocols.
  • Train others in laboratory processes.
• Product Implementation Responsibilities:
  • Support the evaluation of new instrumentation, new protocols or off the shelf tests for FMI use.
  • Draft new SOPs and other documentation to support implementation of assays into small scale laboratory for RUO use from R&D and/or other internal parties.
  • Strong Collaboration across teams to execute on new assay implementation
  • Execute on end user testing and provide requirements and feedback for LIMS workflows.
  • Prepare documentation for equipment qualifications, as required.
  • Execute on equipment qualifications (CQsIQOQPQs)
  • Provide assay and technology requirements for new products.
  • Execute on end to end testing for new products.
• Other Responsibilities:
  • Prepare Samples for training and qualification testing as required.
  • 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.
• Other duties as assigned.
• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• Bachelors degree in 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 FMIs 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
• 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
• Commitment to reflect FMIs values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $87,200 - $109,000 per year. The salary range is commensurate with Foundation Medicines 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 Foundation Medicine's benefits.

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