Director, Assay Development

Company: Talis Biomedical
Location: Chicago
Posted on: March 20, 2023

Job Description:

Position Summary:
We are seeking a talented, motivated and driven Director, Assay Development within the R&D division to enable development of rapid diagnostic tests. This high visibility position is an excellent opportunity for individuals seeking a scientific leadership opportunity in the field of moleculr diagnostics.
You will lead members in Assay Development team in assay development and be a pivotal member of the Product Core Team representing the Assay Development function. You will lead all aspects of Assay Development and Assay Verification/validation activities. You will apply your prior experience with Design Controls to develop robust and reliable Product and play a critical role in demonstrating the validity of new assays. You will write assay development plans, protocols and reports and work collaboratively with other departments. You will lead the effort in transferring validated designs to the Operations organization. You will mentor junior scientists and associates on the rigorous development of new assays. Priormolecular In Vitro Diagnostic(IVD) product development experience in infectious disease is preferred. Experience in Loop Mediated Amplification technology is a plus.
This job is located in our Chicago, IL location and may require occasional travel to our Redwood City, California site.
Specific responsibilities include, but are not limited to:

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• Lead Assay Development teams in assay development, optimization, verification and validation.
  
• Design and execute guard-banding studies to ensure robustness on the assays.
  
• Write Assay Development, Verification and validation plans. Directing in writing protocols and reports.
  
• Work with the Bioinformatics Team to finalize assay-specific calling algorithms.
  
• Represent Assay Development on the Product Core Team; collaborate with Program management to build bottoms-up timelines, identify and communicate risks.
  
• Collaborate with the Reagent/QC development team to establish manufacturing work instructions and quality control specifications.
  
• Troubleshoot problems andidentify solutions to technical challenges.
  
• Present data at Development Sub team meetings, Core Team meetings and external meetings.
  
• Hire, develop and manage Assay Development team, including Scientists.
  
  Required Education & Experience
  
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  • D. in Molecular Biology, Biochemistry, Microbiology or a related field with 10+years of experiencein Biotechnology ormolecular IVD industries.
    
  • 5+ years' experience in infectious disease IVD product development, from bench to commercialization.
    
  • 3+ years' management experience, and strong leadership skills.
    
  • Hands-on expertise in nucleic acid amplification (qPCR, isothermal amplification) technology from assay design to optimization and troubleshooting is required.
    
  • Excellence in trouble shooting and optimization skills. Being able to multitasking and at the same time stay focused is highly desirable.
    
  • Excellent written and oral communication skills.
    
  • Experience with current 21 CFR 820 Quality System Regulation, specifically 820.30, Design Controls.
    
    Additional Desired Experience
    
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    • Prior experience with Product Development Core Teams, and/or leading cross-functional assay development sub teams.
      
    • Experience integrating assays onto consumables.
      
      

Keywords: Talis Biomedical, Chicago , Director, Assay Development, Executive , Chicago, Illinois