Senior Scientist

QuidelOrtho•Rochester, NY

1d•Onsite

About The Position

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 At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Scientist to develop new assays for our VITROS analyzer systems. A successful Senior Scientist will be able to apply standard scientific and mathematical principles, theories, concepts, and techniques and will be responsible for leading a compliant development of a new assay on our VITROS chemistry analyzers. The candidate will also be responsible for developing and maintaining an in-depth knowledge regarding our reagent technologies and the assay interactions with the VITROS systems and software. The job will consist of ensuring the assay development is completed within the Quality System according to the project schedule and will be responsible to lead and train others. This position will be located onsite in Rochester, NY.

Requirements

Bachelor’s degree in chemistry or related field with a minimum of 5 years industry experience.
Master’s Degree, or minimum of 1 year’s industry experience or post-doctoral experience with a Ph.D. Degree
Previous experience in experimental design and analytical analysis, including data evaluation and interpretation
Basic computer skills (MS Word, MS Excel) along with experience in MiniTab or other statistical software
Candidates should have excellent written and oral communication skills and a demonstrated ability to work in an interdependent, collaborative environment
Must have excellent written and oral communication skills and a demonstrated ability to work in an interdependent, collaborative environment
This position is not currently eligible for visa sponsorship

Nice To Haves

Analytical Chemistry, Clinical Chemistry, Organic Chemistry, Biochemistry, Protein Chemistry, or Physical Chemistry
Research experience and track record of product development or publications in the area of Clinical Chemistry, Cardiac, Metabolic or Infectious Disease
Experience with evaluation and statistical analysis using methods such as the CLSI documents
Experience in the IVD industry, with GMP/QSR, ISO and related regulations as well as Process / Design Excellence Green Belt or Black Belt training
Experience in identifying and resolving problems for IVD Medical Devices

Responsibilities

Functions as key technical leader on critical development projects ensuring timely commercialization of products that meet customer expectations.
Leads a technical team and plans, designs test protocols, performs testing, analyses the experimental data, and summarizes the results aimed for the development of new VITROS in vitro diagnostic products or processes using established protocols and SOP’s.
Prepares technical reports, including quantitative analysis, and participates in scientific meetings and presents technical findings.
Responsible for maintaining accurate records of work performed in accordance with cGMP and the procedures outlined in the Quality System. This includes Design History Files, other associated testing documentation, and claims papers for regulatory submissions.
Defines and maintains world class best practices in the science of IVD assay and system design that allows them to impact business critical projects across all lines of business.
Mentors lower-level scientists for day-to-day direction, and reviews and approves reports or memos from lower-level scientists.
Performs other work duties as assigned.