R&D Validation Scientist
NAVICAN Genomics, Inc. delivers precision cancer care. All patients deserve access to precision cancer care - the right therapy at the right time to ensure better outcomes and reduced healthcare costs. Today many people don’t get the precision therapy they need, and with the exceptional team of professionals we are building, we believe we can do better. Based on proven processes developed through years of experience and clinical best practices of Intermountain Healthcare, NAVICAN was created to transform advances in precision medicine into precision cancer care for patients everywhere that advanced therapies are available.
Expert prioritized therapy recommendations and experienced treatment navigators will simplify the path to drug and clinical trial access. At the same time, we’ll help patients and their caregivers navigate often frustrating administrative processes. We’re driven by an impatience to make more precision therapy options available to more cancer patients. If you have a passion to help people, a desire to grow, and you excel at what you do, join us at NAVICAN and make a positive impact on the world.
NAVICAN is seeking a highly motivated R&D Scientist to join our team and help us in leveraging cutting-edge laboratory and bioinformatics processes to provide next generation care guidance for late-stage cancer patients. The ideal candidate will work closely with the scientific and clinical production team at NAVICAN to execute validation studies to support regulatory submissions.
The successful candidate must be a high energy, analytical, hard-working team player with an entrepreneurial spirit, who is talented, hands-on, highly ethical and detail oriented. The ideal candidate will have a PhD in molecular biology, biochemistry, human genetics or a related field, with demonstrated experience in molecular diagnostic test development and next generation sequencing in a regulated environment. The candidate will ideally have experience with designing and executing studies and preparing documents for regulatory submissions.
Primary Responsibilities and Essential Duties
- Design and execute experiments for regulatory submissions
- Collaborate with the Director of Regulatory Affairs to compile validation data and write dossiers for regulatory submission
- Design methods for orthogonal variant conformation
- Develop standard operating procedures, validation plans and validation reports for process/product improvements
- Troubleshoot production issues and support the clinical laboratory
- Present regular updates to the team and participate in authoring manuscripts
- Outstanding problem solving, analytical skills
- Outstanding written and oral communication skills
- Outstanding organizational and time management skills
- Excellent attention to detail and ability to perform under pressure
- Ability to work independently as well lead a team
- Collaborative, ambitious, self-starter
- Strives in dynamic, entrepreneurial environments
Education and Experience
- PhD in Molecular Biology, Biochemistry, Human Genetics or related field
- Extensive experience with regulatory agencies and submissions (FDA, NY, CLIA/CAP, etc.)
- Extensive hands on wet bench experience developing and validating Next Generation Sequencing and/or molecular diagnostic tests in a regulated environment
- Strong experimental design and data analysis skills
- Outstanding writing and communication skills
- Understanding of bioinformatics and clinical NGS processes (oncology preferred)
$90k-$110k + performance bonus + stock options + relocation assistance.
Navican is an EOE/AA employer and offers competitive salary and benefits package.