Posted in General Business 30+ days ago.
As a Scientist/Senior Scientist, you will lead molecular diagnostic assay development for the commercialization of IVD assays on the LIAISON MDX. The ideal candidate should have experience in developing molecular diagnostic assays in a regulated environment for FDA 510(k) clearance and commercialization.
MAIN RESPONSIBILITIES | YOUR CONTRIBUTIONS:
-Technical leader/team leader of assay development, directing teams through the planning and execution of molecular IVD product development.
-Plans and executes laboratory research as the technical lead for design control projects.-Produces and analyzes data for publication and presentation at scientific meetings.
-Serves as an in-house consultant and advises management on scientific decisions. Interfaces with various departments during the product development process.
-Responsible for the management and professional development of direct reports. Able to interface with internal and external scientists and other departments.
-Serves as a technical representative, core team or extended team member during the product development process.
-Authors various manufacturing and raw material specifications and QC documents required for transfer of products to manufacturing.
-Authors other documents and reports required during the product development process.
Qualifications Experience Personal Strengths Mobility
-Requires a Ph.D. in a scientific discipline or equivalent and a minimum of 5 to 8 years' experience in a research and/or assay development environment. Post-doctoral work may serve as experience. Non-Ph.D. candidates who have demonstrated exceptional capabilities and a minimum of 10 years' experience in a research and/or development environment will be
QUALIFICATIONS, EXPERIENCE, SKILLS & PERSONAL STRENGTHS | YOU:
-Prior experience in developing IVD products through the design control process required. -Demonstrates ability to exercise independent judgment within defined procedures to determine appropriate action.
-Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
-Expert knowledge of scientific principles and concepts.
-May determine methods and procedures on new assignments and may provide guidance to other departmental personnel.
Research and Assay Development
We Offer You
Competitive Compensation, Medical, Dental, 401k and Paid-time Off (PTO)
Others Information as per Local Legal Requirements
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. EEO/AA-M/F/Disability/Protected Veteran Status/Genetic Data