Person, Text, Face

 

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. 

 

Senior Scientist, Companion Diagnostics

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

About the Job

The Senior Scientist, Companion Diagnostics 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

 

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.

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Molecular Technologist I (Sunday-Thursday 3rd Shift)

Lab Operations 100943 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Operations
About the Job The Molecular Technologist I performs procedures in a complex patient sample testing process with limited supervision. Most prominently, the position is responsible for solution and reagent preparation, equipment maintenance, and th...

Medical Science Liaison - West

Clinical Development and Decision Science 100998 United States United States Medical
About the Job The Medical Science Liaison develops and expands a strong network of Key Opinion Leaders (KOLs) to support FMI’s commercial and scientific objectives. The position is responsible for initiating and sustaining an exchange of scientif...

Senior Project Manager, Portfolio & Program Management

Corporate Management 100762 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Corporate
About the Job The Senior Project Manager, Portfolio and Program Management is responsible for the planning and execution of new biopharma clinical product development projects and/or lab expansion projects, as well as other business critical init...

Employment Counsel

Legal 101098 Boston Massachusetts United States Seaport Blvd., Boston, Massachusetts, United States Corporate
About the Job The Employment Counsel is responsible for advising Foundation Medicine on global employment, labor, immigration, and related matters. As a valued partner to the business, the role will be a direct point of contact for FMI’s People T...

Send to a friend

Not You?

Thank you for sending this job to your friend.

Clothing, Apparel, Person, Scarf, Finger, Plant, Sitting, Female
Lab, Apparel, Clothing, Person, Scientist, Coat, Lab Coat

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)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.