Manager, R&D

Job Summary: The Manager, R&D will be responsible for driving creation of a pipeline of new products/assays that will enable company growth within the POC primary care market (Pediatric, OB/Gyn & Family Practice) as well as assays complementary to the lead platform, i.e., other heavy metals. Collaborate with other departments, Corporate R&D and consultants/external resources to evaluate potential new project areas, define product requirements, and development milestones, confirm regulatory paths, and set timelines and budgets.

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:

The Manager, R&D will be responsible for driving creation of a pipeline of new products/assays that will enable company growth within the POC primary care market (Pediatric, OB/Gyn & Family Practice) as well as assays complementary to the lead platform, i.e., other heavy metals.

Key Duties:

Tasks/Duties/Responsibilities:

• Research and development of electrochemical systems comprising screen-printed sensors, reagents and instruments, for use in clinical applications. Must have the ability to take a project from conception through to commercial launch.
• Collaborate with other departments, Corporate R&D and consultants/external resources to evaluate potential new project areas, define product requirements, and development milestones, confirm regulatory paths, and set timelines and budgets.
• Devise, establish, and execute suitable experiments in order to develop and test various sensor, reagent, and instrument systems.
• Collaborate to develop methodologies, procedures, protocols, documentation, etc. for transfer of developed products to manufacturing.
• Work with intellectual property counsel to devise and provide documentations for any new intellectual property that results from development work.
• Responsible for developing medical diagnostics devices including hardware and software requirements, architecture, design, implementation, integration, verification and validation planning and testing. Leads a team of interdisciplinary engineers and scientists. Also directs external development vendors for embedded and firmware software development, application software development and specification development.
• Ability to lead a team of scientists: organizing, setting expectations and motivating in order to deliver agreed upon goals.
• Ability to interpret complex data and provide clear recommendations, describing the risks and benefits of different approaches.
• Report regularly to executive team on the status of projects in development, including the ability to succinctly report on accomplishments towards a plan, as well as to evaluate and describe development risks and critical success factors.
• Maintain quality laboratory standards and record keeping.
• Ability to assess product development requirements and work with management to set department budgets. Manage department expenditures.
• Other duties as assigned.

Qualifications:

• Degree in Chemistry or Engineering and experience with 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 and analytical chemistry as well as other diagnostic methodologies.
• Travel: 10%
• Curiosity and enthusiasm – a keen interest in discovering what can be done better/differently, and a positive outlook towards change.
• Focus on accomplishment – possessing a drive to get things done.
• Leadership abilities – demonstrated ability to successfully lead people, teams, and projects, and to get results through others.
• Collaborative – ability to work across teams to accomplish company goals.
• Risk tolerant, someone who is flexible and demonstrates perseverance.
• Broad conceptual judgement, initiative and ability to deal with complex factors and ideas not easily evaluated as well as to make sound decisions when data may be limited.
• Strong oral and written communication skills.