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
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.
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)