Jobs · Information Technology · Missouri

Associate Director, R&D Microbiology, Reveal

bioMérieux · Hazelwood, MO · 2 wk ago
Information Technology$132k–$180k/yrFull-time

About the role

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

Responsibilities

  • Owns a portfolio of AST reagent and assay development projects, ensuring delivery of development, verification, and lifecycle milestones aligned with business and regulatory objectives
  • Builds, leads, and develops a high-performing team of individual contributors, establishing clear structure, mentoring scientific talent, and driving accountability and engagement
  • Translates organizational strategy and AST product development goals into clear team objectives, technical deliverables, and execution timelines. Ensures effective execution of complex laboratory and development activities, including reagent formulation, assay optimization, and performance characterization within a regulated IVD environment
  • Provides strong scientific and technical leadership, guiding experimental design, problem-solving, and risk mitigation while supporting both junior and senior scientists
  • Leads or coordinates technical investigations, including deviations, CAPAs, and root cause analyses related to AST reagents and assays. Drives cross-functional alignment and collaboration with quality, regulatory, manufacturing, engineering, and systems teams to ensure successful product development and transfer
  • Ensures compliance with design control, quality systems, and regulatory requirements (FDA, IVDR) across all development and lifecycle activities
  • Owes resource planning and contributes to budget management, ensuring appropriate staffing, prioritization, and allocation of resources across projects
  • 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
  • Establishes and reinforces structured ways of working, including clear roles, responsibilities, and decision-making processes across the team
  • Evaluates and integrates emerging technologies and methodologies to enhance assay performance and maintain competitiveness in IVD diagnostics
  • Ensures robust documentation, data integrity, and traceability, supporting regulatory submissions and long-term product sustainability
  • Acts as a key functional representative in technical decision forums, project reviews, and cross-functional decision-making discussions
  • Performs all work in compliance with company quality procedures and standards. Performs other duties as assigned

Qualifications

  • 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
  • Preferred: 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
  • 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 / CE‑IVDR
  • Strong data analysis and troubleshooting skills, with demonstrated ability to interpret complex datasets and drive technical decision-making; familiarity with JMP, Tableau, or equivalent analytical tools preferred
  • Supervisory Responsibilities (Summary): Provides direct supervision to approximately 6–10 employees and indirect supervision to 11–15 employees, with responsibility for both day-to-day operational oversight and long-term strategic leadership

Working Conditions & Physical Requirements

  • 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.

Pay

The estimated salary range for this role is between $132,000-$180,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living.

Schedule

Domestic travel: 10% International travel: 0%

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