Scientist, Molecular Assay Development

QuidelOrtho•San Diego, CA

1d•$85,000 - $95,000•Onsite

About The Position

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Scientist to support our Molecular Assay Development team and play a key role in advancing innovative diagnostic solutions. In this hands-on R&D role, you will contribute to the design, development, and validation of molecular assays across multiple programs, and help drive assay performance from early feasibility through analytical validation, ultimately supporting the development of high-quality diagnostic products. This position will be onsite full-time at our San Diego, CA (Sorrento Valley) location.

Requirements

Bachelor’s degree in molecular biology, Genetics, Biochemistry, Biomedical Sciences, or related discipline required; Master’s degree preferred
5–8 years of experience in molecular assay development or diagnostics
Experience working in regulated environments (FDA, ISO 13485, design control) preferred
Demonstrated ability to independently design and execute experiments
Experience with qPCR and RT-qPCR techniques
Understanding of nucleic acid extraction, amplification, and detection
Familiarity with multiplex assay development and optimization
Experience with analytical validation and performance characterization
Basic knowledge of sequencing technologies (Sanger and/or NGS)
Strong troubleshooting and problem-solving skills
Knowledge of design control and risk management principles
Working knowledge of BSL-2 laboratory practices
Strong data analysis, documentation, and communication skills
This position is not currently eligible for visa sponsorship.

Responsibilities

Supports molecular assay design and development activities across multiple programs
Conducts feasibility studies and contributes to technical approach selection (e.g., qPCR, RT-qPCR, multiplex strategies) under guidance
Executes experimental plans and generates high-quality data to support assay performance and development milestones
Contributes to analytical validation studies, including LoD, precision, reproducibility, and robustness
Analyzes and interprets molecular data, identifies trends, and communicates results clearly to the team
Supports troubleshooting efforts related to assay chemistry, workflow, and instrumentation
Participates in cross-functional design reviews and provides technical input as appropriate
Contributes to risk assessments (e.g., FMEA) and supports design control activities
Supports development of QC strategies, reference material characterization, and analytical controls
Contributes to regulatory documentation by generating data summaries and technical reports
Collaborates with Manufacturing and Operations teams to support assay transfer and scale-up
Maintains accurate and compliant laboratory documentation in accordance with quality and regulatory requirements
Stays current on emerging molecular technologies and contributes to continuous improvement initiatives
Perform other work-related duties as assigned.