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.

 

Senior Manager, Histology

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

About the Job

The Senior Manager, Histology is a position that leads people and processes in the Histology department. The incumbent’s primary focus is on quality assurance, customer service, developing a “high bar of excellence” for FMI’s histological testing processes, and hiring, training and developing people. This position oversees and, as needed, performs patient sample microtomy, slide staining, embedding, and collaborates frequently cross-site and cross-functionally.

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

• Provide excellent and engaged leadership in planning, execution, and problem resolution of various initiatives.

• Hire, retain, motivate and develop team members to effectively fulfill the mission of FMI.

• Manage the talent pipeline to execute the laboratory operations plan and provide effective leadership succession.

• Direct the activities of Histology laboratory team members to ensure that day-to-day operations are in compliance with internal policies, procedures, and the regulatory standards set forth by Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) and the Food and Drug Administration (FDA).

• Collaborate cross-site and cross-functionally to develop and maintain policies and procedures that guide Histology to support operational excellence.

• Identify areas for process improvement and manage implementation teams to continually optimize process quality and turn-around-times (TATs).

• Define Key Performance Indicators (KPIs) and generate dashboards and reports summarizing productivity and process performance for presentation to senior management.

• Optimize the interface of histology laboratory with downstream activities, including nucleic acid extraction and sequencing-based methodologies.

• Participate in internal and external collaborative partnerships and lead equipment and assay qualification and validation efforts for the introduction of new and updated products and workflows in tissue-based diagnostics.

• Author, contribute to, and review Standard Operating Procedures, tracking forms, training logs, change controls, Non-Conformance reports and investigations, deviations or Corrective and Preventative Action (CAPA) reports as needed to support operational excellence for clinical and biopharma clients.

• Attend scientific conferences and represent FMI’s business externally to commercial and academic partners through talks, tutorials, publications.

• Participate in agency inspections and audits under CAP, FDA and all regulatory guidelines.

• Deliver education-focused presentations to internal and external customers.

• Strong communication and collaboration skills with the ability to multi-task in a growing, fast paced environment.

• Judiciously evaluate priorities and meet ambitious deadlines.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree in a biological or life science or Equivalency.

• 7+ years of professional experience in a Clinical Laboratory Improvement Amendments (CLIA) / College of American Pathologists (CAP)-certified laboratory

• 5+ years of management experience with proven track record of implementing changes, scaling operations for growth, staff development and building successful teams

• 5+ years of experience in leading process or quality improvement projects, allocating resources and prioritizing key deliverables to optimize delivery timelines while meeting all critical requirements

• Histotechnologist American Society for Clinical Pathology (HTL-ASCP) Certified

Preferred Qualifications

• Master’s Degree in a biological or life science

• 7+ years in a cancer diagnostics or oncology setting

• Experience:

  • in a high-volume reference laboratory environment, preferably with a focus on oncology diagnostics
  • leading process improvements
  • with biological specimen storage and shipment
  • leading the systematic optimization and troubleshooting of complex laboratory operational workflows
  • in a Quality System Regulation compliant lab
  • handling multiple tasks at once
  • working within tight timelines for successful execution of project and program goals

• Demonstrated history of thorough follow up on seeing processes through to completion

• Demonstrated mastery of all aspects of Histotechnology and hands on proficiency and understanding of at least one specialized technical or scientific field applicable to Histotechnology performed in a GLP / CAP /CLIA environment

• Detailed knowledge of pathology, clinical test procedures, staining techniques, and applicable testing regulations

• Proficiency utilizing Microsoft Office Suite, especially Excel and PowerPoint

• Strong acumen for program management and process improvement

• Ability to:

  • work independently as well as collaborate with peers in a fast-paced and cross-functional results-oriented team environment
  • work well under pressure while maintaining a professional demeanor
  • prioritize and thoroughly follow up on assigned tasks
  • adapt to changing procedures, policies and work environment
  • perform work in a laboratory environment and in the presence of chemicals and reagents
  • apply performance improvement tools and methodologies such as Lean, JIT, Six Sigma and Flow Manufacturing techniques FMEA, design thinking, etc.

• Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving

• Demonstrated attention to detail and strong organizational skills

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

 

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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