Research Associate III (In Vitro Diagnostics Development)

Bio-Rad Laboratories Pleasanton, CA
Overview

Bio-Rad's Digital Biology Group is a multidisciplinary team developing products using our Droplet DigitalTM technology that are having a large impact in both research and healthcare. Every day, scientists and clinicians around the world use our ddPCRTM and ddSEQTM NGS sample prep systems to make new discoveries, and are revolutionizing clinical decisions with break-through liquid biopsy applications. We're looking for an energetic and talented Research Associate II (IVD Development) to join our team.

Responsibilities

* You will work in an assay development team on development of new in vitro diagnostic (IVD) tests for oncology using state-of-the-art droplet digital PCR (ddPCR) technology, in a multi-disciplinary department that includes assay research and development scientists, hardware engineers and software engineers.

* You will devise novel ddPCR assays and assay designs to be used in new IVD ddPCR tests, and validate them using appropriate test samples.

* You will plan, execute and analyze laboratory studies for the development and optimization of new ddPCR IVD tests, write documents and reports on your studies, develop release testing methods and acceptance criteria, transfer new products to operations and participate in development activities necessary for world-wide regulatory clearance and launch of new products.

* The exquisite sensitivity, specificity and accuracy of ddPCR is uniquely suited to fill a large unmet need in cancer diagnostics, by enabling the testing of non-invasive blood samples (liquid biopsies) rather than tissue biopsies (see http://www.bio-rad.com/en-us/category/digital-pcr?pcp_loc=lnav).

* Join the Digital Biology Group at Bio-Rad, grow your career working on cutting edge technologies, and develop products that help improve patients' lives.

Qualifications

* Drive and passion to develop new in vitro diagnostic products that improve patients' lives.

* Motivated to take ownership of your activities and responsibility for the outcome.

* Bachelor's degree in molecular biology, biochemistry, cell biology or related life science field with 5+ years' experience in development of PCR-based in vitro diagnostic tests or life-science research using molecular techniques, or Master's degree with 2 - 4 years of experience.

* Hands-on experience with DNA/RNA extraction from clinical samples and real-time PCR.

* Assay/oligo development skills a plus.

* Excellent analytical and data analysis skills.

* Experience with statistical analysis software, such as JMP.

* Excellent written and oral communication skills.

* Proficiency in software applications such as Word, Excel, PowerPoint.

* Ability to draft and review technical documents, including test plans, protocols and reports.

* Experience working in an FDA compliant environment.

* Familiarity with CLSI/CLIA guidance a plus.

* Familiarity with the cancer field a plus.

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

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