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.

As we continue to grow as QuidelOrtho, we are seeking a Scientist - High Sensitivity Immunoassay to join our team in the Mira Mesa area of San Diego. As a Senior Scientist, responsibilities include research and development activities toward development and validation of a new high-sensitivity quantitative immunoassay platform. This is an exciting opportunity to apply the latest biochemistry technology and advancements, while working closely with other team members who are developing a state-of-the-art point of care diagnostic device.

Responsibilities may also include transfer of products and technologies to manufacturing, as well as providing technical support to manufacturing in addressing issues that may cause product supply interruptions.

We are seeking someone who is able to:

- Design experiments to develop and optimize assays

- Identify and resolve assay performance issues

- Collaborate with internal and external resources

- Summarize experimental data and draw conclusions independently

- Be responsible for determination of feasibility, process development, validation, creation and implementation of documentation

- Provide technical direction and mentoring tomore junior level employees

- Investigate 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

- Create and review formal documents such as protocols, reports, QC specifications and manufacturing documents preferred.

- Follow established SOPs and general knowledge of GLP/GMP guidelines

This is an onsite role in our San Diego, CA location.

• Perform antibody conjugation and characterization experiments accurately and independently

• Planning and execution of experiments and validation of protocols, provide technical direction and mentoring to Development Associates

• Statistical experimental design, data analysis and interpretation

• Write reports, documents, and protocols

• Review of relevant literature, creative thinking, and application to problem solving

• Maintain detailed and organized notebook records

• Performs other duties & projects as assigned.

Required:

• BA/BS in life sciences, similar field or equivalent and 9-11 years of related experience, OR

• MA/MS in life sciences, similar field or equivalent and at least 8 years of related experience, OR

• PhD in life sciences preferred, similar field, or equivalent and 5-8 years of related experience.

• 5+ years of hands-on experience in immunoassay development

• Background in chemistry, biochemistry, molecular biology, virology, immunology, or related field.

• Specific technical skills as defined by management based on anticipated and approved projects in agreement with strategic company goals and objectives.

• Knowledge of scientific principals and concepts.

• Experience in product development and experimental design.

• Knowledge of advanced methods for statistical experimental design and data analysis.

• Strong analytical and problem solving skills.

• Excellent organizational skills and ability to manage multiple tasks/projects simultaneously.

• Ability to plan and execute experiments to: prove feasibility, develop new processes and set specifications, characterize materials and set specifications, troubleshoot problems.

• Ability to work within cross-functional teams.

• Strong communication skills, written and verbal.

• Must exhibit professionalism, confidence, maturity and display desire to succeed, be self motivated and proactive.

• Knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.)

• Demonstrate ability to consistently meet proposed objective timelines, apply competent use of project planning and project management skills.

• Working knowledge of manufacturing tools and processes.

• Knowledge of quality system regulations and processes.

• Appropriate computer skills (e-mail, word processing, graphing software).

Preferred:

• Diagnostic (IVD) assay development experience.

• Combination of lab and desk environment.

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 $92,900 to $170,000 and is bonus eligible. 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.

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 their 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.

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