Senior Scientist Analytical Development and Quality Assurance

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.

The Senior Scientist – Analytical Development and Quality Assurance is a technical leader responsible for advancing analytical development and ensuring quality assurance for electrochemical analytical devices. This role applies deep expertise in chemistry and materials science to develop, characterize, and validate materials, components, and analytical methods used in electrochemical systems. The Senior Scientist works cross-functionally with R&D, Manufacturing, Quality, and Operations to ensure that product designs and processes are robust, compliant, and scalable.

In addition to technical development, this role plays a key part in creating, reviewing, and maintaining quality documentation to support product development, technology transfer, and manufacturing operations in a regulated environment.

• Lead and support analytical development activities for electrochemical analytical devices, including method development, optimization, and validation.
• Apply expertise in chemistry and materials science to characterize electrodes, coatings, polymers, reagents, and other device materials.
• Design and execute experiments to evaluate material performance, stability, and reliability across development and manufacturing conditions.
• Analyze electrochemical and analytical data to support design decisions, troubleshooting, and continuous improvement.
• Serve as a technical subject matter expert for analytical methods and materials-related issues across the product lifecycle.

• Ensure analytical development and materials-related activities comply with applicable quality system requirements and regulatory standards (e.g., ISO 13485, 21 CFR Part 820, GLP/GMP as applicable).
• Support quality assurance activities, including deviations, nonconformances, CAPAs, change control, and risk management related to materials and analytical methods.
• Participate in internal and external audits by providing technical documentation, data interpretation, and subject matter expertise.

• Author, review, and approve quality and technical documentation to support R&D and manufacturing, including:
  • Development reports and technical assessments
  • Analytical method validation and verification protocols and reports
  • Specifications, test methods, and work instructions
  • Material characterization reports and stability studies
• Support technology transfer from R&D to Manufacturing by ensuring analytical methods and material specifications are clearly defined, validated, and manufacturable.
• Collaborate with Operations to resolve manufacturing issues related to analytical testing, materials performance, or process variability.

• Partner with R&D, Quality, Manufacturing, Supply Chain, and Regulatory teams to integrate analytical and materials considerations into product and process decisions.
• Provide scientific guidance to engineers and scientists on materials selection, analytical testing strategies, and quality requirements.
• Mentor junior scientists and contribute to knowledge sharing within the organization.

• Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
• Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.).
• Must be able to adhere to applicable bio-safety practices when on the manufacturing floor.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
• Must be able to analyze, concentrate, and solve complex issues throughout the workday.

• PhD or MS in Chemistry, Materials Science, Chemical Engineering, or related discipline.
• A minimum of 7 years of industry experience in analytical development, materials characterization, or quality support for medical devices, diagnostics, or electrochemical systems.
• Hands-on experience with electrochemical techniques (e.g., voltammetry, amperometry, impedance spectroscopy) and analytical methods.
• Strong knowledge of quality systems and regulated product development.
• Proven ability to author and maintain high‑quality technical and quality documentation.