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, Molecular Clinical Laboratory Operations

  • Torreyana Road, San Diego, California, United States
  • Full Time

About the Job 

The Manager, Clinical Laboratory Operations plays a key role in the day-to-day operation of Foundation Medicine’s clinical liquid (blood) laboratory operations. The Lab Manager oversees all phases of laboratory testing procedures and may also perform Clinical Lab Scientist (CLS) duties as needed. This position works with the quality/regulatory team to ensure compliance, including clinical testing and validation of new products and processes from Research and Development and in-licensed partners, and represents the clinical laboratory on cross-functional project teams. This role administers proficiency, training, and competency assessment programs and oversees the clinical laboratory occurrence management, non-conformance, and CAPA processes. This position serves as a Technical and General Supervisor under CLIA, California and NY as necessary to support technical and managerial oversight of the clinical laboratory.

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

This role is considered onsite essential.

Key Responsibilities

  • Manage the day-to-day operations of Foundation Medicine’s clinical laboratory for clinical diagnostic testing, including proficiency testing, personnel, lab safety compliance; maintain lab operational workflow and familiarity with troubleshooting NGS workflows, cfDNA workflows, and associated automation.
  • Collaborate with R&D and cross-functional teams to support the technology transfer, operationalization, and optimization of our testing platform.
  • Manage and oversee resources, hiring, training, and scheduling of all employees.
  • Ensure all Foundation Medicine’s policies and procedures are followed, including CLIA and HIPAA requirements as necessary.
  • Work with the Quality team to maintain a Quality Management System that includes QC/QA, and regulatory compliance. Help design and maintain systems for tracking and improving process efficiency. Identify Quality events and change and control existing Quality documents as needed.
  • Monitor the QA metrics, productivity, and attendance of all employees and for the testing platform.
  • Manage highly complex laboratory testing procedures working with blood, DNA and RNA. Demonstrate expertise in NGS, PCR Testing, QC of reagents, validation, instrument maintenance and other duties, as necessary.
  • Manage vendors and maintain strong external partnerships through leveraging supply chain and asset management organizations.
  • Provide day-to-day leadership and management of the team, including ownership for productivity, team development, coaching/mentoring of direct and indirect reports, performance review processes, and daily staff briefings.
  • Ensure that laboratory staff are fully trained and compliant with all CLIA, FDA, CAP, and other applicable state regulatory requirements.
  • Promote cross-functional relationships with customer service/client services team in order to illicit customer-centric feedback and implementation into laboratory operation changes.
  • Strong understanding of reagent QC/manufacturing as it relates to clinical lab operations.
  • Travel domestically up to 10% of the time.
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s degree in Molecular Biology, Biochemistry, Microbiology or Chemistry or 4+ years of relevant experience
  • ASCP clinical lab scientist certification with qualifications to serve as General and Technical Supervisor under CLIA, California and New York
  • CA licensure as Clinical Laboratory Scientist (CLS) or Molecular Technologist (CGMBS)
  • 8+ years of experience in molecular based testing in a clinical lab
  • 3+ years of managerial experience in a CLIA lab environment

Preferred Qualifications

  • Advanced degree in a chemical, physical, or biological science discipline
  • 5+ years of managerial experience in a CLIA lab environment
  • Extensive experience with molecular-based clinical testing methods, including NGS
  • Working knowledge of CLIA, CAP, and New York quality system principles, concepts, systems, industry practices, and standards
  • Knowledge of FDA quality system regulations
  • Demonstrated strong leadership with timely achievement of goals while utilizing an OKR framework
  • Ability to foster a high performance, teamwork-oriented laboratory environment
  • Good understanding of statistical methods and application to the analysis of complex molecular diagnostic assays
  • Familiarity with regulated clinical operation of laboratory instruments and applicable computer software
  • Familiarity with designing clinical lab build-out
  • Strong interpersonal skills and high communication proficiency, both verbal and written, in technical and non-technical domains
  • Ability to act as a team player and mentor others
  • Willingness to work flexible hours in support of our patients
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: 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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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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