Scientist, Molecular Assay Development

The Opportunity

Quidel Ortho 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 Quidel Ortho, 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.

• 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.

• 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.

• R&D and Assay Development Teams
  - Execute experiments, generate data, and support assay optimization
• Bioinformatics
  - Collaborate on target selection, sequence analysis, and assay performance
• Regulatory and Quality
  - Provide technical data and documentation to support submissions
• Manufacturing and Operations
  - Support assay transfer and process optimization
• Program Management
  - Communicate progress, risks, and timelines

• CROs and external partners
  - Support execution of external studies
• Reference material suppliers
  - Assist with qualification and performance monitoring

At Quidel Ortho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together - Collaborate intentionally, grow as a team
• Make It Happen - Focus on priorities, embrace continuous improvement
• Commit to Service - Cultivate a service mindset
• Embrace Inclusion - Be open and authentic, welcome diverse perspectives

The work environment…