Scientist, Medical Technologist & Lab Technician, Clinical Research

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 I supporting assay R&D in Rochester, NY. The Scientist I will work collaboratively within a team environment to support all phases of Assay Development activities. This role is responsible for performing laboratory assignments related to experimental design, execution, and evaluation of assay performance on VITROS and other Quidel Ortho diagnostic platforms in compliance with current Good Manufacturing Practices (cGMP) and established Quality System requirements.

Responsibilities include test execution, documentation, analysis, and summarization of experimental data, as well as preparation of complex biological solutions using established laboratory procedures and protocols.

Additional laboratory responsibilities may include preparation and reconstitution of calibrators and controls; weighing chemicals; performing volumetric additions of biological components; pipetting; filtration and ultrafiltration procedures; and other standard laboratory techniques.

• Collaborate as part of a technical team to create, execute, and interpret experimental test designs for VITROS analyzers in support of verification and validation activities for new in vitro diagnostic products and processes, following established protocols and Standard Operating Procedures (SOPs).
• Execute assay performance testing on diagnostic instrumentation to support accurate, reliable, and reproducible test results.
• Perform routine analyzer maintenance, including daily, weekly, and monthly maintenance activities, as well as calibration, quality control (QC), troubleshooting, and documentation in accordance with SOPs.
• Maintain accurate, complete, and compliant records of all work performed in alignment with cGMP requirements and Quality System procedures, including Design History Files, QC documentation, equipment maintenance records, and associated laboratory documentation.
• Maintain a clean, organized, and safe laboratory environment, including proper cleaning and maintenance of work spaces and instrumentation following testing activities.
• Complete required training and support training activities related to SOPs, protocols, laboratory procedures, and other controlled documents.
• Support additional laboratory and project-related activities as assigned.
• Overtime may be required based on business and project needs.

Required:

• Bachelor's degree in Chemistry, Biology, Biochemistry, Biotechnology, Medical Technology, Clinical Laboratory Science, or a related scientific discipline.
• Minimum of 1 year of relevant laboratory experience or an equivalent combination of education and experience.
• Basic understanding of laboratory techniques, scientific methodology, and data analysis.
• Ability to perform general biochemical laboratory…