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.

 

Manager, Lab Operations

  • Kit Creek Road, Morrisville, North Carolina, United States
  • Full Time

About the Job

The Manager, Laboratory Operations is responsible for providing training, coaching, policy and procedure enforcement to the laboratory operations staff at a given location and in particular acts as a support to the Technical Supervisors and Molecular Technologists on location. An effective incumbent ensures that all operations that occur in the department are documented and well understood by employees within a given department. This leadership position also provides individual contributions. 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.

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

Key Responsibilities

  • Manage laboratory processes to ensure day-to-day operations are in compliance with internal standard operating procedures, quality system, and regulatory standards as applicable from Clinical Laboratory Improvement Amendments (CLIA), College of American Pathology (CAP), and the Food and Drug Administration (FDA).
  • Manage direct reports, including Molecular Laboratory Technical Supervisors and Molecular Laboratory personnel by preparing schedules, monitoring process metrics, providing guidance and direction, preparing development activities, and conducting performance evaluations.
  • Collect, maintain, evaluate and report department specific metrics.
  • 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.
  • Leverage a deep understanding of the process in troubleshooting assays and instrumentation as needed.
  • Investigate and problem solve laboratory and department incidents, including writing or reviewing non-conformance reports, deviations, Corrective Action and Preventative Actions (CAPAs), or incident reports.
  • Act as a decision maker on tactical issues operationally and systemically for designated shift.
  • Report issues impacting specimen processing or quality to lab leadership.
  • Provide on-boarding or ensure training, competency evaluations, and continuing education goals and requirements are met for all laboratory personnel.
  • Establish department goals and deadlines that pertain to initiatives and circulate these to all staff impacted.
  • Manage workflows based upon sample details and volume and assist laboratory staff, in particular any direct reports, with project prioritization for best turn-around time.
  • Support resolutions to Client Services or other department inquiries.
  • Collaborate with internal teams, vendors, and others as needed to resolve issues, maintain ongoing functionality and document service, project management, and repair work.
  • Represent laboratory operations department at cross functional meetings as needed.
  • Assist in preparing for, performing and responding to internal and external audits as well as any other inspections.
  • Maintain quality, continuous improvement and objectives regarding turn-around-time.
  • Maintain flexibility to cover scheduling gaps as needed and to be included in the on-call rotation to support 24/7 operations.
  • Additional duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s of Science Degree in a chemical, physical or biological science
  • 6+ years experience in a molecular clinical laboratory
  • 3+ years of progressively responsible experience in a laboratory operations leadership role

Preferred Qualifications

  • Advanced degree in a chemical, physical, or biological science discipline
  • Demonstrated experience:
    • In a leadership or management capacity, providing training, feedback and mentorship to supervisors and/or lead technologists
    • Working in a regulated molecular diagnostics and clinical laboratory setting, adhering to requirements established in FDA – Quality System Regulations, European Union, CLIA, CAP, Good Laboratory Practices, and International Organization for Standardization
    • Maintaining and ensuring compliance with a Quality Management System
    • Driving complex projects in the face of ambiguity
  • Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, automated liquid handlers, sequencers, etc.)
  • Understanding of HIPAA and need to maintain privacy patient data
  • Proficiency utilizing Microsoft Office Suite, specifically Excel and Power Point

 

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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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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