Senior Principal Microbiologist

Role: Senior Principal Microbiologist leading microbiological control strategies and QC system startup at Lilly's new Parenteral, Device, and Packaging facility. Responsibilities: design and qualify microbiology testing, environmental monitoring, and clean utilities systems (PW, WFI, steam, gases); lead method development, validation, and lifecycle management; investigate deviations, out-of-spec results, and excursions; author technical reports and support regulatory inspections; mentor staff and contribute to quality standards. Requirements: Bachelor's in microbiology or related field; 7-10 years GMP microbiology laboratory experience, with expertise in endotoxin, bioburden, sterility testing, and regulatory compliance; strong communication skills; leadership capabilities. Preferred: problem-solving skills, root cause analysis proficiency, continuous improvement mindset, regulatory knowledge. HighValue: GMP microbiology, sterile manufacturing, clean utilities, qualification/validation, regulatory interactions, lab system design and startup, limited travel. WorkSetup: full-time, on-site in North Carolina, with occasional shift work and off-shift responsiveness.