Staff Scientist

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.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Staff Scientist for research and development toward development and validation of new products and transfer products and technologies to manufacturing. May include providing technical support to manufacturing in addressing issues that may or can cause product supply interruptions.

This will be an onsite position located in our San Diego, Ca office.

The Position

• Develop scientific plans and approaches, plan and manage projects
• Mentors and directs the work of other R&D employees
• Accomplish objectives through sound project management
• Design experiments to develop products and optimize assays
• Identify and resolve assay performance issues
• Collaborate with internal and external resources
• Summarize experimental data and draw conclusions independently
• Responsible for determination of feasibility, process development, raw material, in process, product specifications validation, creation and implementation of documentation, and training of personnel
• Provides technical direction and mentoring to lower-level employees.
• Investigates the feasibility of applying a wide variety of scientific concepts to potential products, implements new methods or procedures.
• Maintain project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process
• Maintain a safe working environment.
• Develop QC standards and test methods
• Support the development of FMEA's and product design documentation
• Perform other work-related duties as assigned.

The Individual

Required:

• BA/BS in life sciences, similar field or equivalent and 15 years of related experience, or
• MA/MS in life sciences, similar field or equivalent and at least 14 years of related experience, or
• PhD in life sciences, similar field, or equivalent and 12 years of related experience
• Scientific excellence and recognition as a result of publications and patents highly preferred
• Proven key contributions to development projects, marketed products and strategic activities highly preferred
• Proven track record in successfully participating in interdisciplinary teams working on technical or methodological projects and successfully transferring development products into manufacturing highly preferred Planning and execution of experiments and validation of protocols, directs the work of other R&D employees
• Review of relevant literature, creative thinking, and application to problem solving
• Statistical experimental design, data analysis and interpretation
• Write reports, documents, and protocols
• Maintain detailed and organized notebook records
• Participate in team environments and interact with team members professionally
• Maintain a safe working environment, travel, training, carries out duties in compliance with established business policies, remain current with appropriate scientific literature
• This position is not currently eligible for visa sponsorship.

Preferred:

• Demonstrated expertise in lateral flow immunoassay development, including assay optimization, scale-up, and manufacturing transfer.
• Proven track record of leading programs from feasibility through FDA submission.
• Strong leadership and mentoring skills, with experience guiding scientists and cross-functional teams.
• Solid understanding of design control, risk management, and regulatory standards (FDA, ISO 13485).
• Excellent problem-solving, project management, and communication skills.
• Experience with multiplex assays, novel detection technologies, or advanced materials for lateral flow platforms.
• Familiarity with clinical study design, statistical analysis, and clinical sample testing.
• Ability to manage multiple projects while maintaining a focus on quality and timelines.

The Key Stakeholders

Internal Partners:

• Working cross functionally with multiple organizations such as Operations, Program Management, R&D etc

External Partners:

• Contractors and vendors.

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines

Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel required. Travel includes airplane, automobile travel and overnight hotel.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $135,000-$165,000 [and is bonus eligible or eligible for incentive compensation.] QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.