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MANAGER, ASSAY DEVELOPMENT
Ortho Clinical Diagnostics, Inc., a Johnson & Johnson company, is recruiting for a Manager, Assay Development in our Assay Research & Development organization located in Rochester, NY.
Ortho Clinical Diagnostics believes that many of the world's most serious diseases can be detected before they put a person's life at risk. For that reason, we create the highest quality in vitro diagnostic products that give health professionals the knowledge they need to determine the best treatment. As a Johnson & Johnson company, our work provides people around the world with the potential for a better quality of life at every stage of their life. We give people the power of knowing about conditions early to make the right decisions for a faster path to health.
The Manager, Assay Development, will report to the Director of Content Development and will direct a department engaged in the development of new point of care assay / reagent products. They will be responsible for delivering reliable, low cost, assay / reagent designs that meet or exceed customer expectations for ease of use, analytical performance and clinical utility. They will ensure that scientific best practices are consistently implemented in all technical project work and that business commitments (cost, time, quality) for delivering new product designs are consistently achieved. In addition, they will ensure that all project related work is conducted in compliance with FDA / QSR and other international regulations related to in vitro diagnostic devices and products. The Manager, Product Development, will be responsible for developing and maintaining an organization of skilled and experienced scientific professionals to meet the current and future product development requirements of Ortho Clinical Diagnostics and our business partners. This position will develop individual staff members through regular one-to-one discussions and will provide consistent support and feed-back concerning employee performance, growth opportunities, and career development.
This position requires a minimum of a Bachelors degree with 10 years of relevant experience or a Masters or other advanced degree with 8 years of relevant experience.
A degree in the biological or chemical sciences along with experience leading technical teams in an industrial R&D setting is required.
Candidates must possess a demonstrated track record of successfully designing and validating analytical methods including immunoassays for use in clinical / medical applications.
Direct experience in the Pharmaceutical and / or Medical Devices and Diagnostics industry with a focus in point of care products and technologies is highly preferred.
Experience with GMP/QSR, ISO and related regulations is required.
Process / Design Excellence Green Belt or Black Belt training is highly desired.
Candidates should have excellent written and oral communication skills and a demonstrated ability to work in an interdependent, collaborative environment. This position may require approximately up to 25% domestic and international travel.
This position is based in Rochester, NY.
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