The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.
Watch the video to see how each member has the chance to make a real impact.
• Manage, author and lead development, verification, and validation studies for novel diagnostic next generation sequencing assays.
• Manage a team comprised of scientists and research associates and conduct hiring, performance review, and development activities for direct reports.
• Manage training and performance qualification testing during tech transfer between the development and operations teams.
• Manage a team supporting product documentation in fulfillment of QSR design control, and ensure optimal documentation of:
· CDx assay requirements;
· Functional specifications;
· Performance and study results; and,
· Data management.
• Partner collaboratively with the Regulatory Affairs and Quality Assurance Teams to ensure that all procedural and submission documentation meets audit, compliance, and accreditation standards.
• Work collaboratively cross-functionally to establish and validate performance parameters, quality control, and stability specifications.
• Support the timely processing and reporting of oncology samples to internal and external collaborators.
• Manage and 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).
• Other duties as assigned.
• Master’s Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or related field
• 8+ years of experience in a laboratory setting in the life sciences industry and/or academia
• Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field
• 10+ years of working experience in in the life sciences industry and/or academia in a laboratory setting
• Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment
• Prior experience managing a team of scientists of all levels
• Prior working experience:
· In product development, assay development, and clinical services;
· Developing, implementing and supporting high complexity clinical assays in a regulated environment (such as with FDA-QSR, CLIA, CAP, ISO regulations);
· Writing standard operating procedures, validation protocols and data reports adherent to regulations;
· Communicating with regulatory bodies and participating in audits; and
· Utilizing robotic liquid handlers, lab automation and instrumentation
• Ability to work well under pressure while maintaining a professional demeanor
• Excellent organizational skills and attention to detail
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
• Demonstrated track record of timely completion ahead of deadlines
• Demonstrated ability to work in a dynamic fast paced team environment
• Strong interpersonal skills that include excellent skill in collaboration and problem solving with other departments and colleagues
• Understanding of HIPAA and importance of privacy of patient data
Internal applicants, please use your FMI email address.