Microbiology Lab Lead: GMP Manufacturing

FP Labs; Chanhassen (MN); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Comprehensive Benefits Package

401(k) with company contributions

Paid time off and leave

Job summary

Federal Package in Chanhassen, MN is seeking a Microbiology Supervisor to lead the in-house microbiology laboratory and actively perform testing, troubleshooting, and daily operations.

The role balances hands-on testing with supervisory responsibilities, regulatory compliance, and continuous improvement to ensure product quality and robust microbiological controls. The successful candidate will mentor staff and manage budget and equipment.

Qualifications

• Bachelor's degree in Microbiology, Biology, or related field.
• Minimum of 5 years of progressive microbiological testing experience, preferably in personal care, OTC, or pharmaceutical manufacturing.
• Hands-on experience with microbiological testing and laboratory equipment.
• Knowledge of GMP, GLP, FDA regulations.
• Ability to train and mentor laboratory personnel.

Responsibilities

• Lead and develop the Microbiology Laboratory while actively performing testing and daily operations.
• Perform microbiological testing, prepare samples, operate laboratory equipment, analyze results, and troubleshoot testing issues.
• Develop and improve microbiological testing methods, laboratory procedures, and internal testing capabilities.
• Train and provide technical guidance to laboratory personnel.
• Ensure compliance with FDA regulations, cGMP, GLP, GDP, and company procedures.
• Communicate failing or out-of-specification (OOS) results, document deviations, and support investigations.
• Monitor microbiological trends and recommend improvements to laboratory processes and manufacturing controls.
• Manage third-party testing laboratories, departmental budgets, equipment maintenance, and calibration requirements.
• Evaluate new laboratory equipment and support qualification activities (IQ/OQ/PQ), as applicable.
• Partner with Quality, Production, and R&D to resolve issues and maintain product quality.

Skills

Leadership

Regulatory compliance

Troubleshooting

Communication

Education

Bachelor's degree in Microbiology, Biology, or related field

Tools

IQ/OQ/PQ processes

Laboratory equipment calibration

Job description

Federal Package in Chanhassen, MN is seeking a Microbiology Supervisor to lead the in-house microbiology laboratory and actively perform testing, troubleshooting, and daily operations.

The role balances hands-on testing with supervisory responsibilities, regulatory compliance, and continuous improvement to ensure product quality and robust microbiological controls. The successful candidate will mentor staff and manage budget and equipment.