Senior Principal Microbiologist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization Overview: Lilly's Concord, North Carolina site is a state-of-the-art Parenteral, Device, and Packaging Assembly Facility dedicated to manufacturing high-quality medicines for patients worldwide. The Quality Control Laboratory plays a critical role in ensuring the safety, quality, and efficacy of drug and drug-device combination products through the execution of robust product testing, supporting reliable and compliant operations across the site. 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 completes 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: Review, interpret, and release raw material, in-process, and finished product data. Serve as SME for Clean Utilities systems (PW, WFI, clean steam, and process gases) and microbiological test methods. Support qualification, validation, and lifecycle management of Clean Utilities systems. Lead or support investigations, including deviations, OOS results, utility excursions, adverse trends, and root cause analyses. Author, execute, and oversee method verifications, transfers, validations, and investigational testing. Monitor method and process performance and drive continuous improvement of laboratory quality systems. Develop, review, and approve SOPs, training materials, and quality documentation. Provide technical training and mentorship to laboratory personnel. Contribute to product reviews, process validations, and global quality initiatives. Serve as SME during internal and external audits and regulatory inspections. Collaborate with cross-functional partners to resolve quality issues and ensure compliance with safety and quality standards. Minimum Requirements: Bachelors 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. Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1 Additional Preferences: Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology. Demonstrated strong interpersonal interaction skills. Ability to focus on continuous improvement. Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations. Deep understanding of compliance requirements and regulatory expectations. Leadership and influence 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. Other Information: Tasks may require repetitive motion and standing for long periods of time. 8-hour days – Monday through Friday. Occasional shift work when required within the lab. Required to be available off shift and respond to operational issues. Minimal travel required. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an 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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$117,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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