Senior Development Scientist I

About the position

At Freenome, we are seeking a Senior Development Scientist I to help grow the Freenome Genomic Early Development team. The ideal candidate will serve as a subject matter expert and technical lead in the development and optimization of new and existing NGS assay workflows and processes. You will collaborate extensively with the Molecular Research, Computational Science, Late Development, Manufacturing, Quality, Regulatory & Program Management teams to develop and transfer technologies into a regulated, high-throughput environment and contribute to Freenome's multiomic product portfolio aimed at early cancer detection. 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. This role reports to the Senior Manager, Development. This role will be an onsite role based in our Brisbane, California headquarters.

Responsibilities

• Applies knowledge of molecular biology, nucleic-acid biochemistry, and next-generation sequencing to develop and optimize assays for DNA and other bioanalytes, including genome-wide and targeted approaches, by following principles of Design Controls for IVD product development.
• Provides hands-on technical expertise in the prototype assay tech transfer from Research to Development, and leads subsequent Design and Development of NGS assays into high throughput automated assays with improved performance in early cancer detection.
• Develops and characterizes new reagents, controls, automated processes, and define in process controls and assay performance requirements.
• Develops R&D tools to troubleshoot root cause of workflow failure and proposes solutions to improve assay performance and robustness.
• Leads from the bench by training and mentoring junior team members while also performing your own experiments in order to facilitate rapid progress toward project goals.
• Participate in project planning and prioritization through a deep understanding of company objectives and available resources, and reprioritizes as needed, and collaborate with appropriate stakeholders to more effectively plan.
• Collaborates with Quality Control Lab, Manufacturing lab, Quality, and Regulatory to transfer reagent quality control methods and manufacturing processes from Development to Operations.
• Maintains detailed records of experiments, data, results and methodologies in compliance with Good Laboratory and Documentation Practices (cGLP, cGDP), authors study protocols and reports, contribute to work instructions and record forms in collaboration with Operations.

Requirements

• A Ph.D with at least 6 years of related experience or a Bachelor's degree with at least 12 years of related experience in molecular biology, biochemistry, genetics, or a related field with experience in NGS-based assay development.
• In-depth technical knowledge and extensive hands-on experience in NGS based assay development including sample preparation, nucleic acid extraction, library preparation, target capture, and sequencing.
• Proven track record of establishing new methods for NGS-based assays, troubleshooting root cause of complex workflow failure, and effectively collaborating with key stakeholders to keep the priority project timeline on track.
• Familiarity with programing in a scientific programming language (e.g., Python or R) and perform bioinformatics analyses to enable experimental iteration independent of external support.
• Strong written and verbal communication skills. Ability to effectively communicate with technical and non-technical teams.

Nice-to-haves

• Experience working in a regulated laboratory environment (CLIA, GLP/GCLP, IVD development) is strongly desired.
• Experience in tech transfer from Research to Development and/or from Development to Operations is strongly desired.
• Experience with methylated ctDNA/cfDNA is a plus.

Benefits

• The US target range of our base salary 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.