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.

 

Functional Lead

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Functional Lead provides leadership of all Lab Operations development related aspects of the Distributed and Tissue Life Cycle teams (LCTs). This position is accountable for the success of FMI’s portfolio from concept to commercialization, including feasibility, development projects, product launches, and commercial supply. The incumbent coordinates LCT development activities with Lab Operations, Supply Chain, Client Services, Clinical Bioinformatics, Translational Oncology and Clinical Reporting.

Key Responsibilities

  • Primary operations member of the Life Cycle development teams for the portfolio. Represents operations interests in the planning, development, and launch of new products.
  • Ensures alignment of LCT and QTOPS goals – and proactively manages conflicts and trade-off decisions when they occur.
  • Ensures robust design transfer of scalable assays.
  • Drives sourcing strategy and vendor selection.
  • Drives effective two-way communication between life cycle teams and functional areas within Operations.
  • Assists in development of and assures execution of strategic and operational plans for assigned Life Cycle teams.
  • Provides accurate and timely financial / budget information to ensure fact-based portfolio management and resource utilization.
  • Oversees the implementation of operations owned activities critical to life cycle initiatives. These activities include but are not limited to launch of new platform and upgrades as well as lifecycle management of on market product.
  • Ensures that optimization processes in Operations are continuously pushed forward and implemented.
  • Ensures the compliance to regulatory (e.g. GMP) and legal requirements (occupational health and safety as well as protection of the environment) and represents the interests of Operations with internal and external parties.
  • Travel up to 30% of the time (dependent on LCT).
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s degree in relevant technical field (chemistry, molecular biology, engineering etc.)
  • 8+ years related operations experience in a leadership role; Pharmaceutical/Healthcare Industry background
  • 3+ years of experience in Next Generation Sequencing
  • 3+ years of experience developing, implementing and supporting high complexity

Preferred Qualifications

  • MBA or other Post Graduate Degree
  • Applied knowledge of product development processes with familiarity in the design control process
  • Ability to manage conflict and encourage collaboration, and successfully implement change
  • Demonstrated competencies in team leadership, team facilitation, and team member participation
  • Demonstrated ability to engage and deliver through indirect staff across many departments, countries, and cultures
  • Ability to deliver in a complex global organization
  • Strong communication skills (oral and written) with the ability to present at the functional and executive levels
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion

#Hybrid

 

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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