Director of Microbiology

Job Title: Director of Microbiology



Location: Boca Raton, FL



Type: Direct Hire



Work Model: Onsite

Overview
Join a fast-growing sterile injectable manufacturing site as the onsite Director of Microbiology, leading sterility assurance, microbiology testing while driving audit readiness and regulatory compliance!

Responsibilities

• Manage and supervise microbiology team
• Oversee microbiological testing, EM, sterility assurance, and media fills
• Ensure regulatory compliance and handle deviations/CAPA/change controls

Requirements

• Bachelor’s, Master’s, or PhD in a relevant field
• 8+ years of microbiology experience in a GMP environment
• 5+ years of recent GMP sterile injectable experience
• 5+ years of management experience
• 5+ years of method development & validation experience
• Participation in audits and direct communication with regulatory bodies (FDA)
• Aseptic & Sterility Assurance expertise
• Sterility assurance and contamination assessment expertise
• Environmental Monitoring Program Management
• GMP/FDA Regulatory Compliance and team leadership
• Candidates must be legally authorized to work in the United States and will not require current or future employer sponsorship for employment

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific