R&D Microbiology Manager
bioMérieux SA, Hazelwood, MO, United States
Description
Position Summary
The IVD Diagnostic Development Manager leads the design, development, optimization, and lifecycle management of antimicrobial susceptibility testing (AST) diagnostic assays and reagents within a regulated environment. The role drives innovation in assays and biomolecule development, supports product and method advancement through biological sample management, and ensures robust analytical verification and validation to meet regulatory requirements. This position also provides technical expertise for sustaining and improving existing diagnostic products while identifying and integrating emerging technologies and trends in IVD diagnostics.
Primary Duties
Builds, leads and oversees a medium-sized team of individual contributors responsible for antimicrobial susceptibility testing (AST) reagent and assay development.
Manages day-to-day operations of complex laboratory activities, including reagent formulation, assay optimization, and performance characterization within a regulated IVD environment.
Maintains organizational strategy and AST product development goals relevant to team objectives, technical deliverables, and execution timelines.
Oversees local budgets, resource planning, and staffing to support development, verification, and support activities.
Provides technical leadership and training to staff members, while fostering cross-functional collaboration with quality, regulatory, manufacturing, and systems teams.
Ensures consistent application of quality systems, design controls, and best practices in compliance with FDA, MDR, and internal quality standards.
Ensure compliance with applicable regulatory requirements (IVDR/MDR).
Identify and implement operational process optimization and efficiency improvements, including development and application of SOPs and best practices.
Perform all work in compliance with company quality procedures and standards.
Qualifications
Required Education, Training and Experience
Bachelor’s degree required — Microbiology or related field.
Minimum of 6 years’ experience in industry and product development, including demonstrated ability to lead a team.
Preferred Education, Training and Experience
Advanced degree preferred; PhD in microbiology or related field.
5+ years of relevant industry experience in microbiology or diagnostic assay development, including a minimum of 3 years in a managerial role within a regulated medical device or diagnostics environment.
Knowledge, Skills, and Abilities (KSAs)
Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared deliverables.
Effective Presentation Skills.
Comfortable giving clear, direct, and actionable feedback.
Strong analytical and problem-solving skills.
Demonstrated ability to make sound decisions using data to guide decision-making and manage complex information.
Demonstrates strong core knowledge; manages complex tasks and integrates multiple tools and technologies.
Demonstrated expertise in microbiological resistance mechanisms and antimicrobial susceptibility testing methodologies.
Experienced supporting verification and validation activities for IVD products, including assays built around ID/AST or CE-IVD.
Strong data analysis and troubleshooting skills, with demonstrated ability to interpret complex datasets and drive technical decision-making.
Strong proficiency with technical data analysis tools, including JMP, Tableau, or equivalent analytical tools.
Supervisory Responsibilities
Direct supervision: 1–5 employees
Indirect supervision: 0 employees
Working Conditions
Travel requirement: up to 10% domestically and 5% internationally
Typical Lab/office environment
The estimated salary range for this role is between $105,000-$140,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
In addition, bioMérieux offers a competitive Total Rewards package that may include:
A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves
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Position Summary
The IVD Diagnostic Development Manager leads the design, development, optimization, and lifecycle management of antimicrobial susceptibility testing (AST) diagnostic assays and reagents within a regulated environment. The role drives innovation in assays and biomolecule development, supports product and method advancement through biological sample management, and ensures robust analytical verification and validation to meet regulatory requirements. This position also provides technical expertise for sustaining and improving existing diagnostic products while identifying and integrating emerging technologies and trends in IVD diagnostics.
Primary Duties
Builds, leads and oversees a medium-sized team of individual contributors responsible for antimicrobial susceptibility testing (AST) reagent and assay development.
Manages day-to-day operations of complex laboratory activities, including reagent formulation, assay optimization, and performance characterization within a regulated IVD environment.
Maintains organizational strategy and AST product development goals relevant to team objectives, technical deliverables, and execution timelines.
Oversees local budgets, resource planning, and staffing to support development, verification, and support activities.
Provides technical leadership and training to staff members, while fostering cross-functional collaboration with quality, regulatory, manufacturing, and systems teams.
Ensures consistent application of quality systems, design controls, and best practices in compliance with FDA, MDR, and internal quality standards.
Ensure compliance with applicable regulatory requirements (IVDR/MDR).
Identify and implement operational process optimization and efficiency improvements, including development and application of SOPs and best practices.
Perform all work in compliance with company quality procedures and standards.
Qualifications
Required Education, Training and Experience
Bachelor’s degree required — Microbiology or related field.
Minimum of 6 years’ experience in industry and product development, including demonstrated ability to lead a team.
Preferred Education, Training and Experience
Advanced degree preferred; PhD in microbiology or related field.
5+ years of relevant industry experience in microbiology or diagnostic assay development, including a minimum of 3 years in a managerial role within a regulated medical device or diagnostics environment.
Knowledge, Skills, and Abilities (KSAs)
Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared deliverables.
Effective Presentation Skills.
Comfortable giving clear, direct, and actionable feedback.
Strong analytical and problem-solving skills.
Demonstrated ability to make sound decisions using data to guide decision-making and manage complex information.
Demonstrates strong core knowledge; manages complex tasks and integrates multiple tools and technologies.
Demonstrated expertise in microbiological resistance mechanisms and antimicrobial susceptibility testing methodologies.
Experienced supporting verification and validation activities for IVD products, including assays built around ID/AST or CE-IVD.
Strong data analysis and troubleshooting skills, with demonstrated ability to interpret complex datasets and drive technical decision-making.
Strong proficiency with technical data analysis tools, including JMP, Tableau, or equivalent analytical tools.
Supervisory Responsibilities
Direct supervision: 1–5 employees
Indirect supervision: 0 employees
Working Conditions
Travel requirement: up to 10% domestically and 5% internationally
Typical Lab/office environment
The estimated salary range for this role is between $105,000-$140,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
In addition, bioMérieux offers a competitive Total Rewards package that may include:
A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves
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