Career Opportunities

Ideation Assay Development Principal Scientist

Posted on: Thursday, February 18, 2021
Organization: Ortho Clinical Diagnostics
Location: Rochester, NY

The Opportunity:

As we continue to grow, we are seeking a Ideation Assay Development  Principal Scientist to work in a team environment exploring fundamental assay parameters on a new disruptive platform for Ortho’s immunoassay systems.  Successful candidates will bring breakthrough mind-sets, diverse perspectives, and disruptive thinking to our organization. The candidates will be able to creatively apply standard scientific and mathematical principles, theories, concepts, and techniques as well as lead cross functional applied research teams. This position is located in Rochester, NY.

The Responsibilities:

  • Lead teams in the definition of fundamental physical chemical and biochemical principles of assays designs, components, performance characterization and troubleshooting of novel immunoassay formats. 

  • Functions as key technical leader on critical advanced development projects ensuring timely completion of defined deliverables. Develops study 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 establishing 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. 

  • Responsible for creating a patent landscape and an intellectual property strategy within the assigned projects.

  • Defines and maintains world class best practices and knowledge 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:

  • Ph.D. degree or equivalent in Chemistry, Biochemistry, Chemical Engineering, Bioengineering or related discipline with good knowledge of immunology and protein chemistry.

  • Research experience and track record of innovation or publications in the area of immunoassay-based biosensors a plus.

  • Previous experience in experimental design and analytical analysis, including data evaluation and interpretation is required.

  • Experience with evaluation and statistical analysis using methods such as the CLSI documents is preferred.

  • Knowledge of statistical principles and methods is desired.

  • Experience in identifying and resolving problems for IVD Medical Devices is preferred.

  • Previous experience with early phase investigations (Advanced Development) where resources are limited and there is need make decisions rapidly to solve difficult problems.

  • Ability to work as part of a cross-functional team to come up with creative solutions.

  • Knowledge of appropriate KOLs in specific areas of interest.

  • Previous experience with microfluidic technology a plus.

  • Previous experience with IVD assay development.

  • Ability to multitask to direct smart, efficient assay testing of donor screening assays in order to assess multiple detection concepts (photonics, colorimetry, and fluorescence) using early prototype instruments and analysis tools.

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