Senior Scientist, Assay Development

About Epigenomics

Epigenomics develops and commercializes patient-friendly, blood-based diagnostic tests across multiple cancer indications with high medical need. Using blood as a liquid biopsy can improve patient access to cancer screening and thereby contribute to eradicate today’s deadliest cancer types such as colorectal, liver, and lung cancer. By leveraging our product pipeline and strong intellectual property, we aim to become a global leader in blood-based cancer detection. There are so many reasons why highly talented people want to join Epigenomics. To name a few: it’s the opportunity to work with many different disciplines and nationalities on every project. It’s the opportunity to push things forward, to feel the immense motivation of the team, to contribute to a better, more accurate and convenient detection of cancer. For more information about Epigenomics, please visit www.epigenomics.com .

Career Opportunity:  Senior Scientist, Assay Development

The Epigenomics R&D Operations team is looking for a Senior Scientist, Assay Development to be responsible for serving as the scientific lead for the development of in vitro diagnostic (IVD) assays in the US. The candidate will lead early-stage development and optimization of products as well as late-stage Design Control testing in support of IVD product submissions to the FDA.

Key Responsibilities:

Plan and execute various laboratory activities with limited instruction; Create and execute protocols for IVD product development; Ability to translate corporate goals into executable R&D plans while understanding technical risks, mitigations and alternatives; Perform experiments, keep detailed lab notebook, perform data analysis, write reports and communicate results and provide conclusions and proposals to aid in team decision making in a fast-paced research environment using a product development process; Strong sense of pragmatism, time management, ability to prioritize work tasks to meet deadlines in a rapidly evolving environment are critical; Have an open mind and be willing to try new approaches to overcome challenges, and make data-driven decisions; Have prior experience designing and developing nucleic acid-based "sample to answer" molecular diagnostic products within a regulated environment, utilizing design control process required; This role will have assay development functional responsibility as well as cross-functional responsibility in support of technical transfer and regulatory submissions; 5-8 years’ experience in development of molecular biology and/or biochemical applications including DNA based techniques; Product development experience, including assay optimization, reagent development, integration and testing, transfer to production and documentation preferred.

Basic Qualifications:

Master’s degree in a Life Sciences discipline or equivalent. Doctorate degree preferred; BS+15, MS+5, PhD+2 yrs relevant experience in IVD/product development (laboratory developed test experience will be considered); 5-8 years’ experience in development of molecular biology and/or biochemical applications including DNA based techniques Deep expertise in assay development and biomarker technologies in nucleic acid analysis; Proven record of transferring new products to manufacturing and/or QC in a fast-paced environment under design control; Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues; Advanced knowledge of Microsoft Outlook, Word, Excel, Project, PowerPoint, and Internet Applications.

Scope of Position:

This is a "hands-on" laboratory position as a Senior Scientific lead.    

Job Type:

Experienced

Schedule:

Full-time

Location:

San Diego, California

Travel:

No

Equal Employment Opportunity

As an equal opportunity employer, Epigenomics does not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.