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Sr Scientist, Companion Diagnostics

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior Scientist, Development Operations sits on the Companion Diagnostics (CDx) Development Operations Team and is responsible for developing companion diagnostics and for contributing to the regulatory strategy of new NGS-based assays under 21 CFR part 820 QSR Design Control. The position advances the full development lifecycle from concept through to commercial launch. Additionally, 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.

Key Responsibilities

  • Lead, author, and execute development, verification, and validation studies for novel diagnostic next generation sequencing assays.
  • Lead training on new processes as they pertain to applicable cross-functional participants.
  • Manage and conduct 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.
  • Partner with the Regulatory and Quality Assurance teams to ensure that 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.
  • Conduct investigations and analyses to troubleshoot and enhance existing methods, improving assay capabilities and technical robustness.
  • Author detailed, accurate, and accessible records of experimental data.
  • Present the results of experimental data at internal meetings and with external collaborators.
  • Prepare reports for submission to regulatory agencies ( including the FDA).
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • Master’s Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or a related field
  • 6+ years working in the life sciences industry and/or academia in a laboratory setting

Preferred Qualifications

  • Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field
  • 3+ years of working experience in the life sciences industry
  • 3+ years of professional experience with molecular biology techniques
  • Experience:
    • developing, implementing and supporting high complexity clinical assays in a regulated environment (such as with FDA-QSR, CLIA, CAP, ISO regulations)
    • writing regulation-adherent validation protocols, data reports and Standard Operating Procedures
    • with the practices and principals of next generation sequencing, including DNA- seq and target-enrichment
    • with robotic liquid handlers, lab automation, and instrumentation
  • Excellent organization and attention to detail
  • Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
  • Demonstrated track record of timely work completion ahead of deadlines
  • Strong interpersonal skills in collaboration and problem solving with other departments and colleagues
  • Understanding of HIPAA and the importance of patient data privacy
  • Demonstrated ability to work in a dynamic fast paced team environment and to work well under pressure while maintaining a professional demeanor
  • Ability to work in a laboratory environment in the presence of chemicals and reagents
  • 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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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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