Director Assay Development Jobs in Missouri (NOW HIRING)

This position is based in St. Louis, Missouri. A generous relocation package is available for the right candidate.

The Associate Director, R&D Microbiology, Reveal leads the design, development, optimization, and lifecycle management of antimicrobial susceptibility testing (AST) diagnostic assays and reagents within a regulated environment. The role owns a portfolio of development projects within the Reveal program, translating organizational strategy into structured execution plans, clear team objectives, and measurable deliverables. The position establishes strong organizational structure across teams, mentors and develops scientific talent, and ensures disciplined execution against program milestones. It drives efficiencies in product development through process optimization, effective resource utilization, and cross-functional alignment. The role is accountable for delivering robust, compliant products through rigorous analytical verification and validation, while integrating emerging technologies and advancing continuous improvement of existing diagnostic solutions.

1. Owns a portfolio of AST reagent and assay development projects, ensuring delivery of development, verification, and lifecycle milestones aligned with business and regulatory objectives

2. Builds, leads, and develops a high-performing team of individual contributors, establishing clear structure, mentoring scientific talent, and driving accountability and engagement

3. Translates organizational strategy and AST product development goals into clear team objectives, technical deliverables, and execution timelines.

4. Ensures effective execution of complex laboratory and development activities, including reagent formulation, assay optimization, and performance characterization within a regulated IVD environment

5. Provides strong scientific and technical leadership, guiding experimental design, problem-solving, and risk mitigation while supporting both junior and senior scientists

6. Leads or coordinates technical investigations, including deviations, CAPAs, and root cause analyses related to AST reagents and assays.

7. Drives cross-functional alignment and collaboration with quality, regulatory, manufacturing, engineering, and systems teams to ensure successful product development and transfer

8. Ensures compliance with design control, quality systems, and regulatory requirements (FDA, IVDR) across all development and lifecycle activities

9. Owns resource planning and contributes to budget management, ensuring appropriate staffing, prioritization, and allocation of resources across projects

10. Drives efficiencies in product development, identifying and implementing process improvements, standard methodologies, and best practices (including SOP development) to improve speed and quality of execution

11. Establishes and reinforces structured ways of working, including clear roles, responsibilities, and decision-making processes across the team

12. Evaluates and integrates emerging technologies and methodologies to enhance assay performance and maintain competitiveness in IVD diagnostics

13. Ensures robust documentation, data integrity, and traceability, supporting regulatory submissions and long-term product sustainability

14. Acts as a key functional representative in technical decison forums, project reviews, and cross-functional decision-making discussions

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

16. Perform other duties as assigned.

• Bachelor's degree required - Microbiology or related field

• 8+ years of relevant industry experience in diagnostic or regulated product development

• 3 years of proven experience leading teams and delivering complex development programs

• PhD or Master's degree in Microbiology, Molecular Biology, Chemistry, or a related scientific discipline
• Experience in antimicrobial susceptibility testing (AST) assay or reagent development
• Strong knowledge of IVD product development lifecycle, including design controls, verification & validation, and regulatory submissions (FDA, IVDR)
• Experience working in cross-functional environments (quality, regulatory, manufacturing, engineering)
• Demonstrated ability to lead complex technical programs and manage competing priorities
• Experience driving process improvements, standardization, and efficiency in product development
• Strong scientific problem-solving skills and ability to guide teams through complex investigations (e.g., CAPA, root cause analysis)
• Excellent communication and influencing skills across technical and non-technical stakeholders

Knowledge, Skills, and Abilities (KSAs)

• Consistently upholds and reflects the core ethical principles and values that bioMerieux promotes.
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
• Effective Presentation Skills - including the ability to present technical data
• Comfortable giving clear, direct, and actionable feedback
• Inspire and energize individuals to achieve their best performance
• Analyze data and make decisions/recommendations, using data to guide decision-making and provide suggestions for improvement.
• Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently
• Strong understanding of microbiology principles, antimicrobial resistance mechanisms, and antibacterial susceptibility testing methodologies.
• Experience supporting regulatory submissions and lifecycle management activities for IVD products, including FDA 510(k) and EU IVDR / CEIVDR.
• Strong data analysis and troubleshooting skills, with demonstrated ability to interpret complex datasets and drive technical decisionmaking; familiarity with JMP, Tableau, or equivalent analytical tools preferred.

The role provides direct supervision to approximately 6-10 employees and indirect supervision to 11-15 employees, with responsibility for both daytoday operational oversight and longterm strategic leadership.

Working Conditions & Physical Requirements (Summary)

The position requires the ability to remain stationary for prolonged periods, ascend/descend stairs or similar structures, and wear PPE correctly most of the day. No heavy machinery operation or lifting over 50 pounds is required.Domestic travel: 10% International travel: 0%