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The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.

Watch the video above to see how each member has the chance to make a real impact. 

 

Scientist II, Companion Diagnostics

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

About the Job

The Scientist II, Development Operations supports the full development lifecycle, from concept through commercial launch, of new NGS-based assays under 21 CFR part 820 QSR Design Control. This position contributes to laboratory and documentation activities in collaboration with a cross-functional team to verify and validate product requirements, assay design, and assay performance. The position requires validation test planning as well as hands-on execution in the laboratory.

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

Key Responsibilities

• Lead, author, and execute development, verification, and validation studies for novel diagnostic next generation sequencing assays.

• Lead training and performance qualification testing during tech transfer between the development and operations teams.

• Lead product documentation in fulfillment of QSR design control, including CDx assay requirements, functional specifications, performance and study results, and data management.

• Work collaboratively with Quality Assurance and Regulatory teams to ensure that all procedural and submission documentation meets audit and accreditation standards.

• Establish and validate performance parameters, quality control, and stability specifications for critical reagents.

• Support the timely processing and reporting of oncology samples to internal and external collaborators.

• Author detailed, accurate, and accessible records of experimental data, present results at group meetings, to external collaborators, and preparation of reports for submission to regulatory agencies.

• Additional duties as assigned.

Qualifications

Basic Qualifications

• A combination of the following education/experience requirements:

  • (A) Bachelor’s Degree in chemical, physical or biological science or medical technology and 4+ year of laboratory experience in high complexity testing,
  • OR
  • (B) Master’s Degree in chemical, physical or biological science or medical technology with 2+ years of laboratory experience in high complexity testing

Preferred Qualifications

• PhD or MS in Molecular Biology, Biochemistry, Genetics, Cancer Genomics

• Experience

  • in a Quality System Regulations (QSR) part 820 or CLIA/CAP compliant laboratory
  • with moderate & highly complex molecular biology techniques (NGS, PCR, enzymatic manipulation of DNA/RNA)
  • working with typical oncology specimens (e.g. FFPE, Blood, Bone Marrow)
  • operating complex instrumentation (lab automation)
  • in maintaining data in a regulated environment and LIMS
  • in data analysis and interpretation as well as advanced use of analysis tools
  • in development, optimization, validation, and implementation of QSR or CLIA-certified tests including writing SOPs and validation plans/reports

• Demonstrated track record of timely completion of projects in an industry setting

• Excellent technical writing, presentation, and communication skills

• Detail oriented with excellent prioritization and organizational skills

• Ability to deliver results on schedule in a fast-paced, dynamic environment

• Understanding of HIPAA and the importance of patient data privacy

• Commitment to reflect FMI’s values: Passion, Patients, Innovation, and Collaboration

 

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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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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