Senior Development Scientist
Why join Freenome?
Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages.
Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it’s just the beginning.
Founded in 2014, Freenome has ~400 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.
At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.
Become a Freenomer
Do you have what it takes to be a Freenomer? A “Freenomer” is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients’ lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what’s possible, one breakthrough at a time.
About this opportunity:
As a Senior Development Scientist-Preanalytics, you will be responsible for characterizing the impact of a multitude of preanalytical variables on the performance of Freenome’s multiomic tests. You will also make significant contributions in development and analytical verification studies focused on blood collection tube and blood collection kit. In addition to leading development and validation studies and executing as a subject matter expert in preanalytics, you will be required to leverage preanalytical datasets to generate biological insights that inform Freenome’s product development efforts. You will collaborate with the Clinical Development, Lab Operations, and Computational Research teams to ensure that preanalytical considerations are represented in every aspect of Freenome’s research platform and product development process. You will identify ways to rapidly iterate and improve on existing methods to evaluate technologies that can enhance our end-to-end test performance. You will work closely with multiple teams including research team, process engineers, computational science team, and clinical operations in a regulated, high-throughput environment.
What you’ll do:
- Design and execute studies to evaluate the impact of preanalytical variables (including blood collection, shipping, and storage conditions) on sample integrity, analyte stability, and performance impact on multiomic tests.
- Identify preanalytical workflow and protocol improvements by analyzing and developing method data.
- Design and lead the execution of verification and validation studies for IVD assays.
- 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.
- Document product development requirements and author study protocols and reports.
- Work cross-functionally with internal teams (Program Management, Clinical Operations, Regulatory, Quality) and external vendors to plan and execute Development studies.
- Collaborate with Computational Biologists and Biostatisticians to define data analysis approaches for Development and verification studies.
- Mentor junior Scientists and Research Associates in the Preanalytical Development team in the design and execution of Development studies.
Must haves:
- PhD (or equivalent industry related experience) in molecular biology, biochemistry, genetics, protein chemistry or a related field.
- PhD with 6+ years or a Master’s with 8+ years or Bachelors with 10+ years of professional experience. Prior experience in clinical diagnostics environment is preferred.
- 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 designing and leading the execution of verification and validation studies for IVD assays in a regulated laboratory environment (GLP).
- Broad knowledge of protein immunoassays and NGS assays for DNA and RNA, including general nucleic acid biochemistry.
- Clear communications skills, ability to work with team members in the same and adjacent disciplines, and experience mentoring and training research associates.
- Understanding of immunology, cancer biology, and/or the biology of human plasma.
Benefits and additional information:
The US target range of our base salary/hourly rate for new hires is $140,250 - $216,500. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.
Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
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