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 Process Specialist/Product Chemist who will investigate, develops, and conducts the implementation of production and/or new procedures to optimize Chemistry manufacturing processes and regulatory requirements. Assists process development in developing scalable Chemistry processes with improved product yield and reduced costs for manufacturing systems. May assist with maintenance of production equipment. May research and implement new methods and technologies to enhance operations.

The Responsibilities

• Contributes to the identification and resolution of manufacturing issues (scope limited to several and varied manufacturing or chemistries processes)

• Prepares chemistries, not limited to particle dye loading, antibodies and drug derivative modification, purification and complex formulations.

• Collects, formats and analyzes data using moderate to complex instrumentation

• Collaborates with senior staff on experimentation, design of experiment (DOE), on generating written data reports, which include data analysis, key findings and recommendations

• Drafts and revises manufacturing documents

• Operates moderately complex laboratory, manufacturing, or testing equipment

• Participates in the preparation and execution of Engineering and Validation Protocols

• Monitors Manufacturing Assembly and/or Chemistries Production (or other areas) activity and analyzes in-process or chemistries performance

• Carries out duties in compliance with established business policies

• Performs other duties & projects as assigned

The Individual

Required Skills:

• Bachelor's degree in Biology, Chemistry, Life Science, Engineering, other scientific discipline or equivalent

• Four to six years of related experience required

• Working knowledge of regulatory guidelines including QSR, ISO 13485, and CMDR

• Knowledgeable in the use of various database and data analysis programs

• Knowledgeable in Good lab practices and safety techniques

• Proficient with complex lab equipment and procedures

• Working knowledge of experimental design and statistical analysis

• Knowledge on troubleshooting and optimization of reagents and processes

• Demonstrated ability to carry out experiments following established guidelines and summarize results accurately

• Demonstrate problem-solving and troubleshooting skills

• Strong verbal and written communication skills

• Organized and detail oriented

• Knowledge and ability to use MS Office and other manufacturing systems

• Ability to work in a team environment

• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

The Work Environment

• This position operates in a typical office and lab environment. This position is on site in San Diego.

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, its is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. A salary range for this position is $64,300 to $118,000. 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