Staff Sci, Assay Development (Reagents)

About the role

Responsibilities

• 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.

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.

Benefits

• Medical, dental, and vision coverage
• Company-paid life insurance
• 401(k) retirement plan
• Generous paid time off
• Access to additional voluntary benefits, employee perks, and discount programs
• We are committed to supporting the well-being of our employees and providing a strong foundation for both professional and personal success.
• Dental
• Vision
• 401(k)
• PTO