Senior Scientist, Assay Development

The Opportunity

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.

The 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.

The Individual

Required:

• 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
• Ability to travel up to 5%

Preferred:

• Preferably, 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

The Key Working Relationships

Internal Partners:

• Cross functional collaboration with many departments and project team members.

External Partners:

• Meets with suppliers, customers, and/or OEM's

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines

Physical Demands

This position has a light physical demand, and may include occasional sitting, standing, walking, repetitive movements of hands (i.e. typing and pipetting), light grasping, and lifting items weighing up to 20 pounds.

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, 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 $85,000 to $105,000 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.

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 recruiting@quidelortho.com.