Team Leader, Research and Development

Meridian Bioscience Inc.; Cincinnati (OH); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player in medical equipment manufacturing is seeking a dynamic Team Leader for Research and Development. This role involves acting as a technical expert, driving innovative projects, and collaborating across departments to ensure the successful development of diagnostic products. With a focus on quality and compliance, you'll lead discussions, train junior team members, and facilitate technology transfer while contributing to project milestones. Join a forward-thinking company committed to redefining possibilities in life sciences and making a significant impact in the field.

Qualifications

• 10 years of experience with a Bachelor's, or 7 years with a Master's, or 5 years with a Ph.D.
• Proven experience in designing and developing IVD products.

Responsibilities

• Lead R&D projects and serve as a technical expert within the assay team.
• Collaborate with Regulatory Affairs for 510(K) submissions.

Skills

Project Management

Technical Writing

Assay Development

Collaboration

Regulatory Compliance

Education

Bachelor of Science

Master of Science

Ph.D.

Job description

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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 solutions that provide answers with speed, accuracy, and simplicity, redefining possibilities from discovery to diagnosis. We seek talented and passionate individuals to help drive our vision. Our innovative culture encourages discovery and creation through collaboration to solve tough problems.

Job Summary

The primary role is to act as a technical expert on projects, be an experienced writer and reviewer of documents, and work cross-functionally with other departments to drive new product development.

Key Duties

1. Design, develop, and execute research and development projects.
2. Serve as a technical expert in the assay team, leading discussions and brainstorming sessions.
3. Organize internal studies with assay team members.
4. Initiate, collaborate on, and review GMP/QSR documents.
5. Facilitate technology transfer across teams.
6. Collaborate with Regulatory Affairs to prepare 510(K) submissions.
7. Coordinate with Clinical Operations for clinical trials.
8. Train junior team members.
9. Interact with outside vendors and collaborators on assay development.
10. Contribute to achieving project milestones.

Qualifications

1. Bachelor of Science with 10 years of practical experience, or Master of Science with 7 years, or Ph.D. with 5 years.
2. Ability to plan and organize studies within an assay team.
3. Serve as a technical expert to lead discussions and decision-making.
4. Train junior team members and laboratory personnel.
5. Translate business goals into actionable plans, understanding technical risks and mitigations.
6. Proven experience in designing, developing, and transferring IVD products.
7. Ability to work with biohazardous materials, PPE, and in clean room environments.
8. Willingness to travel 0-15%.
9. Commitment to equal employment opportunity regardless of protected statuses.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Information Technology
• Industry: Medical Equipment Manufacturing