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:

At Freenome, we are seeking 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 make significant contributions in development and analytical verification studies focused on blood collection tubes and blood collection kits. In addition to leading development and validation studies 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 Preanalytical Research, Genomic Development, Regulatory, and Computational teams to ensure that preanalytical considerations are represented in every aspect of Freenome’s research platform and product development process. 

The role reports to a Manager, Preanalytics. This role will be an Onsite role based in our Brisbane, California headquarters. 

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 with 6+ years or Master’s with 8+ years or Bachelor’s with 12+ years of professional experience in molecular biology, biochemistry, genetics, protein chemistry or a related field.

• 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.

• Experience designing and leading the execution of verification and validation studies for NGS based IVD assays in a regulated laboratory environment (GLP).

• 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.

Nice to haves:

• Experience with protein immunoassays.

• Experience with PMA submissions.

Benefits and additional information:

The US target range of our