Team Leader, Research and Development

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

The R&D Team Leader leads an R&D assay team with full ownership for the development of an IVD immunoassay analyzer-based product, from concept to commercialization. The Team Leader, R&D works cross functionally with other departments to drive the product to a successful clinical trial, 510(k) FDA clearance and launch. The R&D Team Leader is a technical expert on projects and an experienced writer and reviewer of documents.

Leads an R&D team and project(s) with 3-6 direct reports
• Leads the design and execution of DOEs performed by the assay team
• Functions as a technical expert, encourages smart brainstorming discussions and drives for innovative and creative research approaches
• Reports directly to the Sr. Director of R&D and gives update on progress and challenges
• Leads the day-to-day project activities and focuses on data analysis to support decision on the next study design.
• Drives for healthy interactions within the team and between assay teams for positive and constructive collaboration within the R&D department.
• Drives the development and growth of direct reports and supports bi-directional feedback processes.
• Initiates, collaborates and reviews GMP/QSR documents.
• Conducts and documents experiments following design control processes and best practices.
• Works cross-functionally to facilitate technology transfer, prepare 510(K) submissions and facilitates clinical trials.
• Trains and mentors junior team members.
• Interacts with outside vendors and collaborators on assay development.

• Bachelor of Science with 10 years of practical experience, or Master of Science degree with 7 years of practical experience, or Ph.D. degree with 5 years of practical experience.
• Previous leadership experience is required.
• In-depth knowledge in the areas of microbiology and immunology as related to infectious diseases and immunoassay development is required.
• Experience in designing, developing, and transfer of IVD products from R&D to Operations or similar experience in other fields.
• Ability to work in and lead a team with strong EQ to navigate complex situations.
• Ability to serve as a technical expert to lead discussions and recommend decisions that impact project delivery.
• Ability to translate business unit goals into executable plans, understanding technical risks, mitigations, and alternatives.
• Must be able to concentrate, analyze and solve complex issues throughout the course of the workday.
• Must be able to wear personal protective equipment (gloves, face shields/safety glasses, latex, or nitrile gloves, etc.).
• Will be required to be fully gowned for performing tasks in a clean room environment.
• Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
• Ability to stand, stoop, reach, push and pull throughout the course of the work shift.
• Travel 0-15%

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*