Meridian Bioscience Inc. · 20 hours ago
Senior Scientist Analytical Development and Quality Assurance
US-MA-North Billerica
Full-time
Onsite
Senior Level
7+ years expMeridian Bioscience, Inc. is a fully integrated life science company dedicated to developing innovative diagnostic products. The Senior Scientist – Analytical Development and Quality Assurance is responsible for advancing analytical development and ensuring quality assurance for electrochemical analytical devices, working cross-functionally to maintain compliance and support product development.
BiotechnologyMedical DeviceHealthcareLife ScienceHealth CareHealth DiagnosticsMedical
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
Qualification
Required
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
Company
Meridian Bioscience Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, rare reagents, specialty biologicals and components.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$9MKey Investors
National Institutes of Health
2022-07-07Acquired
2022-01-31Grant· $2.5M
2021-02-03Grant· $5.5M
Leadership Team
Andy Kitzmiller
Chief Executive Officer
J
Julie Smith
Chief Financial Officer
Recent News
2025-10-14
MarketScreener
2025-10-14
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