Head of Microbiology
Head of Microbiology
Boca Raton, FL | Onsite
Sterile Injectable Manufacturing
Full-Time | Department Leadership
About the Job
A growing pharmaceutical manufacturer is seeking a Head of Microbiology to lead microbiology operations at a sterile manufacturing facility. This role will oversee environmental monitoring, sterility assurance, microbiological testing, contamination control, regulatory compliance, and microbiology team leadership.
This is an excellent opportunity for an experienced microbiology leader looking to drive quality and compliance initiatives within a highly regulated manufacturing environment.
Key Responsibilities
- Lead and develop the microbiology function
- Oversee environmental monitoring and sterility assurance programs
- Manage sterility, bioburden, endotoxin, and microbial limit testing activities
- Support contamination investigations, root cause analysis, and CAPAs
- Lead media fill and aseptic process simulation activities
- Ensure inspection readiness and regulatory compliance
- Partner with Manufacturing, QA, QC, Validation, and Engineering teams
- Manage microbiology laboratory operations and personnel
Qualifications
- BS in Microbiology, Biology, Biotechnology, Pharmacy, or related discipline
- 12+ years of pharmaceutical microbiology experience
- Leadership experience within GMP-regulated manufacturing
- Strong background in sterile manufacturing and aseptic processing
- Experience supporting FDA inspections and audit activities
- Expertise in environmental monitoring and sterility assurance
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