Senior QC Microbiology Lead — GMP Lab Expert

Guerbet; North Carolina; On-site; USD 110,000 - 140,000; Full time

Job summary

Guerbet is seeking a QC Microbiology Lead to drive day-to-day operations of the QC Microbiology Laboratory in support of the manufacturing facility. You will plan, direct and supervise administrative activities, evaluate material and product quality, and guide laboratory personnel to ensure test procedures meet regulatory standards.

You will oversee environmental monitoring, sterility and bioburden testing, and method validation with a focus on timely testing, data analysis, and cross‑functional

Qualifications

• BS in Microbiology or life sciences.
• Minimum 6+ years of hands‑on pharmaceutical lab experience.
• Ability to work independently with minimal supervision.

Responsibilities

• Lead protocols and environmental monitoring studies.
• Perform biological assays on raw materials, in-process and finished products.
• Investigate out-of-spec results and lead method validation studies.
• Train staff and ensure SOPs and regulatory document compliance.
• Maintain audit-ready records and monthly data trends.

Skills

Environmental monitoring

Sterility testing

Bioburden

Particulate testing

LAL testing

Data analysis

cGMP knowledge

Education

BS in Microbiology

Tools

Autoclave

Microbiology lab equipment

Excel/PowerPoint

Job description

Guerbet is seeking a QC Microbiology Lead to drive day-to-day operations of the QC Microbiology Laboratory in support of the manufacturing facility. You will plan, direct and supervise administrative activities, evaluate material and product quality, and guide laboratory personnel to ensure test procedures meet regulatory standards.

You will oversee environmental monitoring, sterility and bioburden testing, and method validation with a focus on timely testing, data analysis, and cross‑functional