Associate Director, R&D Microbiology, Reveal

Location: Hazelwood

Description

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.

Primary Duties - Local

Specific Duties

* 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

* Owns 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 decison forums, project reviews, and cross-functional decision-making discussions

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

* Perform other duties as assigned.

Qualifications

Required Education, Training, and Experience

* 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 Education, Training, and Experience

* 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…