What are the responsibilities and job description for the Team Leader, Research and Development position at Meridian Bioscience, Inc.?
About Meridian
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.
Job Summary
Primary role is to act as a technical expert on projects, an experienced writer and reviewer of documents, and to work cross-functionally with other departments to drive new product development.
Key Duties
- Design, develop and execute research and development projects.
- Serve as technical expert in the assay team and lead discussions and brainstorm events.
- Work with assay team members to organize internal studies.
- Initiate, collaborate and review GMP/QSR documents.
- Work cross-functionally to facilitate technology transfer.
- Work with Regulatory Affairs to prepare 510(K) submissions.
- Work with Clinical Operations to facilitate clinical trials.
- Train junior team members.
- Interact with outside vendors and collaborators on assay development.
- Contribute to completion of milestones associated with specific projects.
Qualifications
- Bachelor of Science degree 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
- Ability to plan and organize studies within an assay team.
- Ability to serve as a technical expert to lead discussions and recommend decisions that impact project delivery.
- Ability to train junior team members in the assay team and laboratory personnel at clinical sites.
- Ability to translate business unit goals into executable plans understanding technical risks, mitigations, and alternatives.
- Proven record of designing, developing, and transferring IVD products. 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.
- Experiments may involve materials that are considered potentially biohazardous. Must be able to work with human substances such as blood.
- 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)*
