Associate Director, Microbiology
Core
Provide strategic, scientific, and functional leadership for microbiology activities supporting the discovery, development, registration, commercialization, and lifecycle management of antimicrobial and infection-prevention products.
Role type
Associate Director, Microbiology (Strategic Leadership & Program Management)
Builds
Antimicrobial and infection-prevention product portfolios
Domain
Medical Technology / Life Sciences (Regulated)
Required skills
Microbiology expertise, Antimicrobial product development, Regulatory strategy (FDA/cGMP/GLP/ISO), Cross-functional leadership, Organizational capability building, Strategic planning, Risk management, Stakeholder influence, Technical due diligence, Talent development
Preferred skills
PhD in Microbiology, Experience in pharmaceutical or medical device industry
Technologies
cGMP, GLP, ISO, FDA 21 CFR Parts 210/211/820
Responsibilities
Define and drive microbiology strategy for innovation and new product development programs; Lead microbiological evaluation and qualification of new technologies and test methods; Ensure compliance with global medical device and pharmaceutical regulations; Act as senior technical decision-maker for complex microbiology issues; Represent Microbiology in portfolio governance and regulatory strategy discussions; Lead technical due diligence of external technologies and partnerships; Oversee laboratory strategy, safety, compliance, and capability investments; Build organizational capability through workforce planning and mentoring; Author and defend microbiology content in regulatory submissions.
Seniority
Senior, hands-on IC with management responsibilities