Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S.Quidel is looking for a Scientist - High Sensitivity Immunoassay to join our team in the Mira Mesa area of San Diego. As a 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.- 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- Responsible for determination of feasibility, process development, validation, creation and implementation of documentation- Provides technical direction and mentoring to more junior 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- Familiarity with creating and reviewing formal documents such as protocols, reports, QC specifications and manufacturing documents preferred.- Ability to follow established SOPs and general knowledge of GLP/GMP guidelinesEssential Functions• 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 recordsEducation and Experience• BA/BS in life sciences, similar field or equivalent and 7-9 years of related experience, or• MA/MS in life sciences, similar field or equivalent and at least 6 years of related experience, or• PhD in life sciences preferred, similar field, or equivalent and 2-5 years of related experience • 5  years of hands-on experience in immunoassay development• Diagnostic (IVD) assay development experience preferredKnowledge/Skills• 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)