Senior Microbiologist Lead, Clean Utilities & GMP

BioSpace; Concord (NC); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly is designing and building a state-of-the-art QC Microbiology laboratory in Concord, NC. The Sr. Principal Microbiologist will lead microbiological control strategies, support Clean Utilities, and mentor staff while ensuring regulatory readiness and ongoing improvements across testing, validation, and process transfers.

The role emphasizes problem solving, collaboration with partners, and strong documentation to support regulatory and technical submissions.

Qualifications

• Bachelor's degree in a science field related to microbiology or biology.
• 7–10 years of GMP Microbiology Lab experience preferred.
• Strong oral and written communication skills.
• Authorized to work in the United States full-time (no visa sponsorship).
• Experience with endotoxin, bioburden, sterility, bioassay, and related analyses.

Responsibilities

• Lead and design microbiological testing and environmental monitoring lab systems at the Concord site.
• Oversee Clean Utilities qualification, validation, and lifecycle management for PW, WFI, clean steam, and gases.
• Develop, validate, transfer, and document microbiological methods and associated tech transfer.
• Provide technical mentoring to lab staff and collaborate with cross-functional teams.
• Support regulatory inspections and ensure inspection readiness; drive continuous improvement in quality systems.

Skills

GMP Microbiology

Quality systems

Investigation & root cause analysis

Leadership & mentoring

Communication skills

Education

Bachelor's degree in science (microbiology/biology)

Job description

Lilly is designing and building a state-of-the-art QC Microbiology laboratory in Concord, NC. The Sr. Principal Microbiologist will lead microbiological control strategies, support Clean Utilities, and mentor staff while ensuring regulatory readiness and ongoing improvements across testing, validation, and process transfers.

The role emphasizes problem solving, collaboration with partners, and strong documentation to support regulatory and technical submissions.