||Thursday, February 18, 2021
||Ortho Clinical Diagnostics
As we continue to grow, we are seeking a Research & Development Senior Scientist to develop new assays and support or improve existing assays for our Transfusion Medicine 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 Transfusion Medicine analyzers while developing and maintaining an in-depth knowledge regarding our reagent technologies and the assay interactions with the analyzer systems and software. The job will consist of ensuring that assay development is completed within the Ortho Quality System according to the project schedule and the individual will be responsible to lead and train others.
This position will be located in Raritan, NJ.
- Functions as key technical leader on critical development projects ensuring timely commercialization of products that meet customer expectations. Leads a technical team and plans and designs test protocols, performs testing, analyses experimental data, and summarizes results aimed for the development of new 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 and other associated testing documentation required 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.
- A Bachelor’s degree in Chemistry, Biology, Biochemistry, Biotechnology, Medical Technology, or related scientific field. A minimum of 6 years industrial experience with a Master’s Degree; or Ph.D. degree with industrial experience or post-doctoral experience 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 Immunohematology 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.
- Ability to work well in a collaborative team environment and capable of working across multiple projects.
- Experience with evaluation and statistical analysis methods 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 a plus.
- Experience in identifying and resolving problems for IVD Medical Devices is preferred.
- Travel less than 10%.
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