Senior Scientist Analytical Development and Quality Assurance

Meridian Bioscience • North Billerica, MA

5d

About The Position

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 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.

Requirements

• 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.
• Expertise in understanding and applying principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485.
• Advanced skills using Microsoft Word and Excel.
• Ability to independently conduct product or process quality investigations.
• Ability to interact in internal and external audits and act as a role model for the QA department.
• Detail and process oriented.
• Utilize critical thinking skills to problem solve and troubleshoot.
• Ability to communicate (written and verbal) and interact effectively with all levels of the organization.
• Good organizational skills and strong attention to detail.
• Must be able to perform job requirements independently with minimal supervision.
• Adjusts easily and readily to a fast-paced work environment with changing priorities

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree