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.
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Ref: #558-Scientific
