Freenome is seeking a Senior Development Scientist - IVD
About the Role
At Freenome, you will help develop the assay technologies used to analyze patient samples and contribute to our mission of early detection and intervention in human disease. As a Senior Development Scientist - IVD, you will provide expertise in next-generation-sequencing (NGS)-based analyses of DNA and RNA and Design Control for IVD development. Starting with a prototype assay, you will contribute to developing, optimizing, and validating clinical-grade assays to measure complex, blood-based analytes (e.g., whole-genome sequencing of cfDNA). You will work closely with engineers to automate the assays and with clinical staff to transfer technologies into a regulated, high-throughput environment. You will use your analytical and programming abilities to identify ways to rapidly iterate and improve on existing methods, and you will work closely with computational biologists to evaluate technologies that can enhance our end-to-end test performance.
How you’ll contribute:
- Apply expert knowledge of molecular biology, nucleic-acid biochemistry, and next-generation sequencing to develop assays for DNA,RNA, protein, and other bioanalytes including genome-wide and targeted approaches.
- Develop assays by converting manual prototypes into optimized, high-throughput validated assays.
- Analyze existing and development method data to identify workflow and protocol improvements.
- Lead from the bench by training and mentoring scientists while also performing your own experiments in order to facilitate rapid progress toward project goals.
- Collaborate with computational biologists and software engineers to build analysis pipelines and to integrate new molecular technologies into analytical workflows.
- Collaborate with clinical laboratory members to transition development protocols into production, including automation, validation experiments, and SOP development.
- Apply your knowledge of Design Control, Quality Management and Risk Mitigation to product and study design.
What you bring:
- A Ph.D. (or commensurate experience) in molecular biology, biochemistry, genetics, chemistry, or a related field with 3+ years of post-PhD experience in NGS-based assay development
- Experience in molecular diagnostic assay development, preferably in an FDA regulated environment for IVD under design control. LDT/CLIA and CE-IVD experience will also be considered. PMA submission experience desired.
- Experience developing Multi-Analyte Assays with Algorithmic Analysis (MAAA) and/or In Vitro Diagnostic Multivariate Index Assays (IVDMIA).
- Broad, expert-level knowledge of NGS assays for DNA and RNA, including general nucleic acid biochemistry as well as specific optimizations for different applications, sequencing platforms, and analytes.
- Proven track record of establishing new methods for NGS-based measurements of biology (*-seq) that go beyond kitted assays.
- Ability to program in a scientific programming language (e.g., Python or R) and perform bioinformatics analyses to enable experimental iteration independent of external support.
- Clear communications skills, ability to work with team members in the same and adjacent disciplines, and experience mentoring and training research associates
- Ability to design for automated platforms in plate-based, low-volume formats, and/or microfluidics and experience working with automated liquid handlers.
- Hands-on proficiency in managing technology transfer requirements, including guard-banding, stability studies, drafting work instructions, and in-process quality control.
- Understanding of the biology of human cell-free nucleic acids, single-cell analysis methods, immunology, and/or cancer biology.
Freenome has adopted a COVID-19 vaccination policy to safeguard the health and well-being of our employees. As a condition of employment, our employees working on-site are required to be fully vaccinated for COVID-19, unless a reasonable accommodation is approved or as otherwise required by law.
Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer.
We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw. By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science.
Our recent $270 Million Series C brings our financing to over $500 million from investors, including; Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences.
Freenome is building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure.
By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states, including cancer, autoimmune disorders, infections, drug response, and aging. The synthesis of Freenome’s datasets, cross-functional technical expertise, and audacious mission to discover biological truth, we seek to improve the lives of millions through early detection and early treatment of disease.
Freenomers are technical, creative, visionary, grounded, empathetic, and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time.
We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve. We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives. We believe in empowering and supporting each other in a collaborative and dynamic environment.
What does a successful person look like at Freenome?
Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others’ good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there’s no better place to be than Freenome.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.