Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As we continue to grow, we are seeking numerous Research & Development Senior Scientists to develop new assays for our VITROS analyzer systems. The successful candidate 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 while 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 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 report or memos from lower level scientists.

The Individual

• A degree in Chemistry or related field. Preferably, Analytical Chemistry, Clinical Chemistry, Organic Chemistry, Biochemistry, Protein Chemistry, Immunology or Material Science with a minimum of 5 years industrial experience with a Bachelor’s Degree, 3 years industrial experience with a Master’s Degree, or a minimum of 1 year industrial experience with a Ph.D. Degree is required
• Successful candidates will have made strong independent technical contributions that are substantiated by a track record of peer-reviewed publications, patents, and / or commercialized products.
• Research experience and track record of product development or publications in the area of Clinical Chemistry, Cardiac, Metabolic or Infectious Disease is a plus.
• Previous experience in experimental design and analytical analysis, including data evaluation and interpretation is required.
• Basic computer skills (MS Word, MS Excel) along with experience in MiniTab or other statistical software is desired.
• Experience with evaluation and statistical analysis using methods such as the CLSI documents is preferred.
• Candidates should have excellent written and oral communication skills and a demonstrated ability to work in an interdependent, collaborative environment.
• Experience in the IVD industry, with GMP/QSR, ISO and related regulations as well as Process / Design Excellence Green Belt or Black Belt training is preferred.
• Experience in identifying and resolving problems for IVD Medical Devices is preferred.
• Travel less than 10% required