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