Associate Director, Microbiology





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Job Description

Job Summary

The Associate Director, Microbiology provides strategic, scientific, and functional leadership for microbiology activities supporting the discovery, development, registration, commercialization, and lifecycle management of antimicrobial and infection-prevention products. The role is accountable for the technical accuracy, quality, compliance, prioritization, and timely delivery of microbiology programs conducted through internal and external resources.

Operating with a high degree of independence and strategic ownership, the Associate Director defines and drives microbiology strategy across innovation and new product development portfolios. The role translates business, customer, clinical, regulatory, and manufacturing needs into executable scientific strategies; influences cross-functional and portfolio decisions; develops organizational capability; and advances novel, differentiated solutions through internal expertise, external partners, and scientific thought leaders.

Job Responsibilities

• Define and independently drive the microbiology strategy for innovation and new product development programs from opportunity assessment and concept feasibility through design verification, validation, regulatory submission, launch, and lifecycle support.
• Provide strategic scientific leadership across a portfolio of innovation and product development programs, establishing priorities, decision criteria, technical milestones, resource plans, budgets, governance expectations, and risk-mitigation strategies.
• Create and maintain a forward-looking microbiology technology and capability roadmap aligned with business strategy, unmet clinical needs, market opportunities, and product portfolio priorities.
• Lead the microbiological evaluation, development, and qualification of new antimicrobial technologies, test methods, and product concepts that support differentiated and clinically relevant solutions.
• Ensure product development and delivery are consistent with corporate standards and meet applicable performance, quality, regulatory, manufacturability, and business requirements.
• Incorporate applicable global medical device and pharmaceutical regulations, quality-system requirements, standards, and corporate and local policies into program strategy, experimental design, execution, documentation, and decision-making.
• Act as a senior technical and functional decision-maker for complex microbiology issues, making sound recommendations with limited oversight and clearly communicating scientific rationale, risk, tradeoffs, and business impact to senior leadership.
• Represent Microbiology in portfolio governance, design and phase reviews, regulatory strategy discussions, and senior leadership reviews, ensuring decisions are supported by appropriate evidence and transparent assessment of technical and program risk.
• Influence product and portfolio direction through evidence-based recommendations and effective partnership with R&D, Marketing, Medical, Clinical, Regulatory, Quality, Manufacturing, Operations, Sales, and business leadership.
• Lead technical due diligence and microbiology assessments of external technologies, licensing opportunities, suppliers, acquisitions, strategic collaborations, and external testing partners, as applicable.
• Establish and manage high-value scientific collaborations and partnerships that accelerate business objectives and expand access to differentiated technologies and capabilities.
• Provide microbiology leadership and sustaining support for marketed products, product changes, investigations, regulatory commitments, and lifecycle-management activities.
• Author, review, and defend microbiology-related content in regulatory submissions and responses for products under development and on the market.
• Oversee laboratory strategy, priorities, safety, compliance, training, equipment and capability investments, culture collections, space planning, data integrity, and continuous improvement.
• Ensure robust experimental design, method development and qualification, data documentation, and scientific records that support product decisions, technology development, regulatory filings, and intellectual property.
• Build organizational capability through workforce planning, succession planning, hiring, performance management, coaching, mentoring, talent development, and establishment of scientific standards and communities of practice.

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