Manager, R&D

About the Company

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, redefining the possibilities of life from discovery to diagnosis. Our innovative culture allows interested candidates to discover and create through collaboration, cutting edge solutions to tough problems.

Responsibilities

• Drive creation of a pipeline of new products/assays for the POC primary care market (Pediatric, OB/Gyn & Family Practice) and assays complementary to the lead platform, including other heavy metals.
• Research and develop electrochemical systems comprising screen-printed sensors, reagents, and instruments for clinical applications, taking projects from conception to commercial launch.
• Collaborate with other departments, Corporate R&D, and external resources to evaluate new project areas, define product requirements, development milestones, regulatory paths, timelines, and budgets.
• Devise, establish, and execute experiments to develop and test sensor, reagent, and instrument systems.
• Develop methodologies, procedures, protocols, and documentation for transferring products to manufacturing.
• Work with intellectual property counsel to document new intellectual property from development work.
• Develop medical diagnostics devices, including hardware and software requirements, architecture, design, implementation, integration, verification, and validation planning and testing.
• Lead a team of interdisciplinary engineers and scientists, as well as direct external development vendors for embedded/firmware software, application software, and specification development.
• Organize, set expectations, and motivate a team of scientists to deliver agreed-upon goals.
• Interpret complex data and provide clear recommendations, outlining risks and benefits of different approaches.
• Report regularly to the executive team on project status, accomplishments, risks, and critical success factors.
• Maintain quality laboratory standards and record keeping.
• Assess product development requirements and work with management to set department budgets.
• Manage department expenditures.
• Perform other duties as assigned.

Requirements

• Degree in Chemistry or Engineering with experience in regulated medical products.
• Experience in point-of-care systems is a plus.
• Bachelor’s degree with 12 years of practical experience, or Master of Science degree with 9 years of practical experience, or Ph.D. degree with 7 years of practical experience.
• A minimum of 3 years of leadership experience.
• Knowledge of FDA regulatory requirements for IVD products, including Phase Review process.
• Broad knowledge of electrochemistry, analytical chemistry, and other diagnostic methodologies.
• 10% travel required.

Skills

• Curiosity and enthusiasm with a keen interest in discovering improvements and a positive outlook toward change.
• Drive to accomplish goals and get things done.
• Demonstrated leadership abilities in leading people, teams, and projects to achieve results.
• Collaborative approach to working across teams to accomplish company goals.
• Risk tolerance, flexibility, and perseverance.
• Broad conceptual judgment, initiative, and ability to deal with complex factors and make sound decisions with limited data.
• Strong oral and written communication skills.

Pay

$130,000 to $165,000 with a target 10% bonus.