Director, Microbiology

Job Responsibilities

Leads microbiology strategy for new product development initiatives, including sterility testing, environmental monitoring, bioburden, and experimental applications for the Growth Direct® System.

Oversees day-to-day operations of the R&D microbiology laboratory, including resource planning, workflow optimization, equipment management, and budget control.

Directs experimental design, validation studies, and feasibility programs within GLP/GMP frameworks.

Provides technical leadership for growth media formulation, scale-up, and manufacturing validation.

Serves as a microbiology SME for cross-functional product development teams, supporting design requirements, design verification, risk assessments, and regulatory submissions.

Manages laboratory personnel, including hiring, performance management, mentoring, and career development.

Ensures compliance with safety protocols, quality systems, and laboratory best practices.

Oversees demo laboratory operations and customer application projects, supporting commercial growth and key account strategies.

Partners with Quality and Manufacturing teams to align best practices and ensure scalable, compliant solutions.

Reviews and approves complex technical reports, validation protocols, and study results.

Leads technical investigations, root cause analyses, and risk-based decision-making related to customer support activities.

Supports global customer engagements, technical presentations, and strategic account initiatives.

Drives continuous improvement initiatives focused on efficiency, cost optimization, and scientific advancement.

Manages laboratory inventory, capital planning, and instrument asset utilization.

Completes special strategic projects including competitive analysis, statistical studies, and product feasibility assessments.

Education

Bachelor’s degree in microbiology or related life science discipline required. Master’s degree preferred.

Work Experience

10+ years of progressive experience in pharmaceutical, biotech, CRO, CDMO, or regulated laboratory environments, including leadership experience in GLP/GMP settings.

Technical Experience

Sterility testing, bioburden, and environmental monitoring

Rapid microbiological methods

Growth media formulation and validation

Method validation and regulatory compliance

Product development lifecycle in regulated environments

Leadership and Business Competencies

Portfolio prioritization and cross-functional program leadership

Budget management and capital planning

Talent development and performance management

Strategic thinking aligned to commercial objectives

Strong analytical and risk-based decision-making skills