Senior Principal Microbiologist

Position Description The Sr. Principal Microbiologist influences and participates in the design and installation of systems, procedures, and methods for the startup of the QC Microbiological testing and environmental monitoring labs at the site. Additionally, the Sr. Principal Microbiologist participates in the design, installation, qualification, and startup of Clean Utilities systems supporting GMP manufacturing operations. This role provides technical leadership for microbiological control strategies for Purified Water (PW), Water for Injection (WFI), clean steam, compressed gases, and associated distribution systems. The Sr. Principal Microbiologist leads and supports Clean Utilities qualification, validation, technology transfer, remediation, and lifecycle management activities. The Sr. Principal Microbiologist leads the design and execution of method development, validations, technology transfers, and equipment evaluation/qualification. The Sr. Principal Microbiologist utilizes their technical skills to ensure inspection readiness, perform in-depth problem solving, proactively identify opportunities for continuous improvement, and complete thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented by the Sr. Principal Microbiologist and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff, sharing technical information and best practice within the work group and across plant sites. Key Objectives / Deliverables Technical review, interpretation, and release of raw material, in-process, and finished product data. Serve as subject‑matter expert for Clean Utilities systems, including PW, WFI, clean steam, and critical process gases. Serve as subject‑matter expert for Microbiological Test Methods Support qualification, validation, and lifecycle management of Clean Utilities systems. Contribute to annual product reviews and process validations as required. Perform technical training and mentor analysts through formal process/program. Lead and/or review change controls and complex deviations. Utilize technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draw conclusions and perform root cause analysis investigations and recommend solutions to prevent recurrence. Lead investigations into Clean Utilities excursions and adverse trends. Develop investigational testing protocols and perform testing as required. Author and oversee the execution of method verifications, transfers, and validations. Monitor method and process performance. Improve lab quality systems; develop content, review, and approve SOPs and training as necessary. Contribute to development and implementation of Global Lab Quality Standards. Comply with and implement safety standards. Provide technical oversight for Periodic Management Reviews. Interact effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements. Act as SME for internal and external inspections, interacting directly with inspectors and regulatory agencies. Minimum Requirements Bachelor’s (4-year) degree in a science field related to microbiology or biology. 7-10 years of demonstrated relevant experience in a GMP Microbiology Laboratory, preferably associated with GMP manufacturing. Demonstrated proficiency in laboratory analysis including, but not limited to endotoxin, bioburden, sterility, bioassay, particulate matter, and organism identification. Strong oral and written communication skills and demonstrated through documentation and presentation skills. Qualified applicants must be authorized to work in the United States on a full‑time basis. Preferred Qualifications Strong problem‑solving skills. Proficiency in Root Cause Analysis methodology. Strong interpersonal interaction skills. Ability to focus on continuous improvement. Comfortable working in a lab environment including wearing appropriate PPE and following safety procedures. Deep understanding of compliance requirements and regulatory expectations. Additional Information Tasks may require repetitive motion and standing for long periods of time. 8‑hour days – Monday through Friday, occasional shift work may be required within the lab. Required to be available off shift and respond to operational issues. Minimal travel required. Compensation & Benefits The anticipated wage for this position is $65,250 - $169,400. The role is full‑time and eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits such as healthcare and dependent day‑care flexible spending accounts, life insurance and death benefits, time‑off and leave of absence benefits, and well‑being benefits such as employee assistance program, fitness benefits, and employee clubs and activities. Equal Employment Opportunity Lilly is a proud EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. #J-18808-Ljbffr 100 Eli Lilly and Company