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Job: Senior Development Scientist (Diagnostics), Xilis, Inc, Durham, NC

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General Information


Job title:
Senior Development Scientist (Diagnostics)
Job location:
Durham, NC  27701 United States
Requisition code:
Date posted:
05/20/2020
Compensation:
Job category:
Process Development
Project Management
Product Development
Research and Development
Employment type:
Full time

Job Description


Xilis, Inc is a Duke startup founded by Duke professors David Hsu (M.D./Ph.D) and Xiling Shen (Ph.D) in Durham, North Carolina. The company has been developing cutting-edge Patient-Derived MicroOrganospheres (PDMO) technology for precision cancer diagnostics and drug development. Xilis’ transformative platform recreates patient-specific tumors in their 3D and environmental complexity at micro-scale ex-vivo, allowing ultra-high-throughput, clinically-relevant, and affordable experimental selection of the safest, most effective drugs for each and every patient in a matter of days. The company is funded by Silicon Valley and New York venture firms that are leaders in the healthcare space and have invested in top precision medicine companies including Foundation Medicine and Guardant Health.

Responsibilities

The candidate will lead Xilis’ product development efforts. As an early member of the technology development team, the candidate will have a pivotal role in building a high-quality culture of product development in the laboratory, taking charge of successful research endeavors towards product launches, working very closely with the operations laboratory, wetlab research, process engineering, automation, product, and engineering to ensure products meet requirements on the laboratory side. The successful candidate will bring tremendous experience and expertise in clinical diagnostic assay development and lead assay optimization efforts, manage high-throughput laboratory requirements, come up with validation designs, run verification studies, and support the operations laboratory to troubleshoot issues. He or she will also serve as a key stakeholders in designing and defining the culture and operating mode of product development at Xilis. Finally, the candidate will serve as a key stakeholder in company-wide activities affecting the laboratory R&D and product development. The candidate will report to the Chief Medical Officer.

By joining the team at an early stage, the candidate will have an outsized impact on fundamentally advancing precision cancer care therapy. In the next few months and years, the candidate will:

- Lead development efforts towards successfully launching diagnostics assay in clinical care
- Plan for wet laboratory aspects of the launch of clinical diagnostic assays, including requirements, CAP/CLIA/NYS/FDA requirements, validation design, evidence development, process controls, batching, pass/fail criteria, cost, scale, etc...
- Design, and execute independently or with the help of a team, on critical experiments
- Support laboratory operations, including longitudinal QC analysis, troubleshooting of issues, and SOP development and maintenance
- Work closely with R&D scientists to transfer research results into robust and scalable industrial processes
- Collaborate with the operations and engineering teams to set the stage for high-throughput deployment of micro-organoid based diagnostics
- Be available to support Medical Science Liaison specialists and other marketing and sales efforts
- Process samples in support of R&D, assay development, and if needed, operational efforts
- Work closely with the operations and quality teams to develop quality assurance (QA) and quality control (QC) protocols
- Operate and influence successfully in a rapidly changing, fast paced, mission-driven environment
- Share thoughts and ideas on how to improve performance in the lab
- Perform support tasks across the company as needs arise

Job Requirements


- A Ph.D. degree and 5+ year of diagnostics assay development experience
- A proven track record of accomplishing critical product development tasks with very limited to no supervision, in record time
- Experience in successfully launching a clinical diagnostic assay as the lead scientist
- Hands-on experience with complex laboratory techniques, as applied to tissue culture, organoid development and management of clinical samples
- A strong enthusiasm for being in the laboratory to personally run experiments
- The ability to perform different tasks, from bench scientist to long-term planner
- A strong sense of commitment, integrity and handling challenges collaboratively
- Experience and interest in a high-growth startup, where communication is key
- The expertise and ambition to build a team in 18 to 24 months as the company grows is a plus
(Job number: 3905220)
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