About Foundation Medicine:
Foundation Medicine 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.
Foundation Medicine is seeking a Senior Research Associate in the Companion Diagnostics (CDx)/Development Operations team to support the full development lifecycle, from concept through commercial launch, of new NGS-based assays under Design Control.
Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine is developing clinical laboratory tests that will broadly capture the most relevant tumor genomic and other molecular information and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient.
Foundation Medicine is seeking a Senior Research Associate in the Companion Diagnostics (CDx)/Development Operations team to support the full development lifecycle, from concept through commercial launch, of new NGS-based assays under 21 CFR part 820 QSR Design Control. This position will contribute to laboratory and documentation activities in collaboration with a cross-functional team to verify and validate product requirements, assay design, and assay performance. The ideal candidate will have a strong working understanding of molecular biology and next generation sequencing, including data interpretation, and has research and/or development experience in a dynamic multidisciplinary environment. This role will have a unique opportunity to contribute to the development of a new CDx assay platform in the rapidly growing field of diagnostic next generation sequencing.
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.
Contribute to product documentation in fulfillment of QSR design control, including CDx assay requirements, functional specifications, performance and study results, and data management.
Work 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 (FDA).
Qualifications (Position Skill Set):
Experience in a Quality System Regulations (QSR) part 820 or CLIA/CAP compliant laboratory preferred.
Experience with standard molecular biology techniques (PCR, enzymatic manipulation of DNA/RNA).
Experience working with typical oncology specimens (e.g. FFPE, Blood, Bone Marrow).
Experience operating complex instrumentation (NGS, qPCR, Tape Station, lab automation).
Experience in maintaining data in a regulated environment and LIMS.
Experience in development, optimization, validation, and implementation of CLIA-certified tests including writing SOPs and validation plans/reports.
Excellent technical writing and communication skills.
Must be detail oriented with excellent prioritization and organizational skills.
Must be able to deliver results on schedule in a fast-paced, dynamic environment.
BA/BSc, MS, or equivalent, in Molecular Biology, Biochemistry, Genetics, Cancer Genomics is preferred.
Depending on education: BS plus 5-7 years, or MS plus 4 years working in Industry and/or Academia in a laboratory setting; Industry is preferred.
Demonstrated track record of timely completion of projects.
Demonstrated written and oral presentation skills.
Demonstrated ability to work independently and collaboratively in a dynamic, fast paced team environment.
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.