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

1. Builds, leads and oversees a medium-sized team of individual contributors responsible for antimicrobial susceptibility testing (AST) reagent and assay development.

2. Manages day-to-day operations of complex laboratory activities, including reagent formulation, assay optimization, and performance characterization within a regulated IVD environment.

3. Maintains organizational strategy and AST product development goals relevant to team objectives, technical deliverables, and execution timelines.

4. Oversees local budgets, resource planning, and staffing to support development, verification, and support activities.

5. Provides technical leadership and training to staff members, while fostering cross-functional collaboration with quality, regulatory, manufacturing, and systems teams.

6. Ensures consistent application of quality systems, design controls, and best practices in compliance with FDA, MDR, and internal quality standards.

7. Ensure compliance with applicable regulatory requirements (IVDR/MDR).

8. Identify and implement operational process optimization and efficiency improvements, including development and application of SOPs and best practices.

9. Perform all work in compliance with company quality procedures and standards.

Qualifications

Required Education, Training and Experience

• Bachelor degree required — Microbiology or related field

• 4 years experience in industry and product development.and demonstrated ability to lead  a team

Preferred Education, Training and Experience

1. Advanced degree preferred in microbiology or related field

2. 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

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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).