Staff Sci, Assay Development (Reagents)

The Staff Scientist, Assay Development will contribute to the development of molecular diagnostic assays for FDA-regulated IVD products by partnering closely with the assay development team to optimize assay chemistry, reagent formulations, and analytical performance. This role will focus on reagent development, formulation optimization, lyophilization, stability and shelf-life studies, and analytical validation to ensure robust, reproducible, and manufacturable assay performance. 

The ideal candidate has demonstrated experience developing commercial IVD products and has hands-on experience supporting FDA-regulated product development, including analytical validation, stability studies, Design Controls, and FDA 510(k) submissions. 

• Collaborate with assay development scientists to optimize molecular diagnostic assays through reagent formulation, assay chemistry optimization, and analytical performance improvements.  

• Design, develop, and optimize reagent formulations, including enzymes, primers, probes, buffers, stabilizers, and other assay components to support robust assay performance.  

• Design and execute reagent characterization, stability, accelerated aging, shelf-life, and lyophilization studies to support commercial IVD product development.  

• Design and execute experiments to evaluate and improve assay analytical performance, including sensitivity, specificity, precision, robustness, reproducibility, and limit of detection.  

• Support analytical verification and validation activities and generate technical data to support FDA-regulated IVD product development and FDA 510(k) submissions.  

• Collaborate with Quality, Regulatory Affairs, Engineering, and Manufacturing to support Design Controls, technology transfer, manufacturing readiness, and commercialization.  

• Analyze experimental data, troubleshoot reagent and assay performance issues, and communicate technical findings through reports and presentations.  

• Maintain accurate experimental documentation in accordance with quality system requirements. 

• Expertise in reagent development and formulation for molecular diagnostic or IVD products.  

• Hands-on experience optimizing assay chemistry and improving analytical performance of molecular diagnostic assays.  

• Experience designing and executing reagent stability studies, accelerated aging, shelf-life determination, and lyophilized reagent development.  

• Experience supporting analytical verification and validation of FDA-regulated IVD products.  

• Working knowledge of FDA Design Controls, ISO 13485, CLSI guidelines, and FDA 510(k) requirements.  

• Strong experimental design, statistical analysis, troubleshooting, and scientific problem-solving skills.  

• Excellent technical writing, documentation, communication, and cross-functional collaboration skills.  

• Ability to manage multiple priorities in a fast-paced product development environment. 

• Ph.D. in Molecular Biology, Biochemistry, Chemistry, Biomedical Engineering, Bioengineering, or a related scientific discipline with 5+ years of relevant industry experience, or M.S. with 8+ years of relevant industry experience.  

• Demonstrated 2+ years of experience developing FDA-regulated molecular diagnostic or IVD products.  

• Proven experience with reagent formulation, analytical performance optimization, stability studies, accelerated aging, shelf-life determination, and lyophilized reagent development.  

• Experience supporting analytical validation, FDA 510(k) submissions, and Design Controls for commercial IVD products.  

• Experience working within ISO 13485 and other regulated product development environments.  

• Experience with multiplex fluorescence-based assays, PCR/qPCR, or other molecular diagnostic technologies is highly preferred.  

• Experience supporting technology transfer and commercialization of molecular diagnostic products is preferred.