About MRIGlobalMRIGlobal, an independent research and development organization delivers solutions in global health, national security and defense, and energy and the environment. The organization performs scientific research, advanced engineering, and program integration and management for clients in industry, government, and academia. Established in 1944 as Midwest Research Institute, MRIGlobal is based in Kansas City, Mo., and operates in nine states and Washington, D.C.
Our laboratory located in Kansas City, Missouri is looking for a Principal Scientist - Assay Development, Verification, and Validation that will be responsible for working with teams in the Life Sciences Resource Center to support a variety of programs in our contract research organization. Programs support infectious diseases, surveillance, and diagnostic markets with a diverse portfolio. Program areas include the development of verification/validation studies for in vitro diagnostics for submission to US FDA, and/or international regulatory agencies. Work will support FDA EUA, or 510(k) clearance studies, CE mark testing, or other regulatory IVD testing.
- Ph.D. in Biology, Microbiology, Molecular Biology, Virology, Biochemistry, Immunology, Toxicology, or other related study area and 10 years' experience; M.S. in Biology, Microbiology, Molecular Biology, Virology, Biochemistry, Immunology, Toxicology and a minimum 12 years of related experience; B.S. in Biology, Microbiology, Molecular Biology, Virology, Biochemistry, Immunology, Chemistry and minimum 18 years of related experience; or appropriate combination of education and experience
- 5 years directly related regulatory experience in the medical device/vitro diagnostic device or pharmaceutical area(s) to include supporting FDA verification or validation activities
- Ability to contribute technical knowledge to develop test plans, experimental designs, and analytical methods across Life Sciences Research Center portfolio
- Demonstrated expertise in IVD assay development, optimization, and troubleshooting
- Subject matter expertise to support Commercial development and production of diagnostic immunoassays, including ELISA, lateral flow, and rapid membrane immunoassays
- Experience in the Identification and evaluation of new diagnostic technologies, platforms, and markets
- Experience in Validation, verification, FDA pre-submission, and 510(k) submission for in vitro diagnostic assays
- Experience authoring design verification and validation protocols and reports.
- Demonstrated ability to interface with clients and prepare presentation materials for technical meetings
- Applicants MUST be a U.S. Citizen and be eligible to obtain a Department of Defense Clearance
The Principal Scientist will work with a team of scientists to provide assistance to technical project and programmatic leadership and may include technical guidance to junior staff. Additional responsibilities are:
- Serves as principal researcher as key personnel in role of project leader, task leader, or study director on technical programs. Develops and directs development of research findings, draws conclusions, and develops recommendations through a collaboration effort with team members to accomplish goals
- Sets up design controls for progression of product development through feasibility, verification, and validation phases. Works with team as interface between R&D and validation and tracks milestones through pre-market approval phase of product development
- Prepares and complies with project work plans, SOPs and protocols with adherence to MRIGlobal Quality, and Safety requirements
- Writes technical proposals, protocols, reports, and/or papers for publication or presentation with clear results and concise, well supported conclusions
- Assist clients throughout the development and maturation of their products to insure compliance with FDA requirements
- Prepare and review technical reports, verification and validation protocols, and FDA pre-submission and 510(k) documentation
- Assists in the planning and design of internal studies (including feasibility studies), clinical studies and post-market studies in support of US FDA and international regulatory submissions
- Provides training to cross-functional teams on various regulatory issues and processes.
- As a project leader, directs work by assigning responsibilities and tasks to others and establishes effective controls. Helps ensure that staff have the necessary resources and authority to accomplish the task. Assists in facilitating the professional growth of others through on-the-job training and development of enhanced skills related to their current job and by providing timely feedback on performance
- Establishes a course of action to accomplish a specific project or goal. Plans proper assignments of personnel and appropriate allocation of resources and determines schedule of events. Communicates expectations about tasks and deadlines and develops contingency plans
- Supports multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas
As a Federal Contractor as defined by the Safer Federal Workforce Task Force guidelines, all employees working for MRIGlobal must be vaccinated against COVID-19 or have an approved reasonable exemption by the MRIGlobal Office of Accommodations, regardless of location.
To view all of MRIGlobal's current openings and to ensure that we receive your resume, visit our Career page.
It is the policy of MRIGlobal to provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other applicable federal or state protected classification.