Senior Microbiologist — On-Site, cGMP & QA Leader

Harrow, Inc.; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Harrow, Inc. in the United States is seeking a Senior Microbiologist to lead and perform microbiological testing, method qualification, validation, environmental monitoring, and investigations in support of sterile pharmaceutical manufacturing.

You will serve as a SME for microbiology, ensure compliance with cGMP, USP, FDA regulations, and drive continuous improvement within the Quality Control Laboratory while mentoring staff and collaborating with audits and inspections.

Qualifications

• Bachelor's degree in Microbiology, Biology, Molecular Biology, or related Life Sciences field.
• Master's degree preferred.
• 7-10 years of progressive microbiology experience in a cGMP/FDA-regulated environment.

Responsibilities

• Lead microbiological testing including USP <71> sterility and BET.
• Lead method qualification, validation, transfer, verification, and lifecycle management for microbiological tests.
• Review laboratory data, SOPs, protocols, and CAPA; mentor staff and drive continuous improvement.

Skills

Microbiology expertise

Leadership

Problem solving

Data analysis

Documentation

Education

Bachelor's degree in Microbiology

Master's degree preferred

Tools

LIMS

Electronic quality systems

Microsoft Office

Job description

Harrow, Inc. in the United States is seeking a Senior Microbiologist to lead and perform microbiological testing, method qualification, validation, environmental monitoring, and investigations in support of sterile pharmaceutical manufacturing.

You will serve as a SME for microbiology, ensure compliance with cGMP, USP, FDA regulations, and drive continuous improvement within the Quality Control Laboratory while mentoring staff and collaborating with audits and inspections.