Microbiologist - Contamination Control and Environmental Monitoring Lilly Medicine Foundry

Position Overview Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first‑ever facility of its kind combines research and manufacturing in a single location, allowing Lilly to further develop innovative solutions to optimize manufacturing processes, increase capacity for clinical trial medicines, reduce costs, and lessen environmental impact. The Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase‑appropriate control strategies, and ensures right‑first‑time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotides, and bioconjugates. Through cross‑functional collaboration, PTE influences process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies, aligns with corporate and LRL goals, drives scientific excellence and innovation to accelerate manufacturing advancements, and propels the site toward long‑term business success. In this role, you will be responsible for establishing and implementing the operational microbiological, contamination control and environmental monitoring programs at the Lilly Medicine Foundry. As the microbiology lead for the facility, you will provide technical support for the facility startup, defining microbial and viral control strategies in partnership with engineering, operations, quality control and quality assurance. The role will support all GMP areas and own strategy documents including contamination control, environmental monitoring, FMEA and response plans. You will demonstrate strong data‑driven decision‑making and problem‑solving capabilities, continuously improve process efficiency by implementing new technologies and process improvements, and maximize the benefits of a Digital Plant through data analytics and Process Analytical Technology. Responsibilities Plant Design / Operational Readiness Work with the network and development organizations to ensure a well‑understood, robust and fit‑for‑purpose microbial control strategy is developed and transferred. Establish and own the environmental monitoring program, including development of baseline EMPQ protocols and ongoing monitoring. Utilize an in‑depth knowledge of microbiological controls and associated analytical tests to develop and oversee the contamination control strategy, FMEA and contamination response plan. Implement innovative digital solutions to support accelerated manufacturing processes while ensuring compliance and monitoring needs are documented in electronic systems. Collaborate as part of cross‑functional teams, establish partnerships with applicable functions, operations and analytical labs to understand the interface between science/engineering and operations on the floor, and bring deep technical expertise to the team. Production Support Create, revise, or review documents such as SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, etc.) and perform investigations as needed. Support tech transfer of new entities through assessment of molecule‑specific control strategies and critical quality attributes. Understand basic statistical methodologies to assign specifications, acceptance criteria, sampling criteria and analysis of batch data for summary reports and product reviews. Identify process vulnerabilities and participate in implementation of continuous improvement initiatives. Understand and ensure compliance with safety, compliance, and regulatory expectations. Basic Requirements Minimum BS or MS in microbiology or related discipline. 8+ years of experience (BS) or 5+ years of experience (MS) in facility contamination control and environmental monitoring programs in a clinical or GMP manufacturing environment. 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. Additional Preferences Capable of collaborating effectively within a team, making autonomous decisions, and influencing a diverse range of groups in a fast‑paced environment. Strong communication skills, both oral and written, to effectively communicate technical information in a clear and concise manner. Skilled at developing innovative solutions to plant challenges by applying problem‑solving techniques and interpersonal strengths, while integrating insights from multiple functional areas. Self‑starter with high initiative and a data‑driven approach to problem‑solving. Proficient in MS Office (Word, Excel, Project, Outlook, etc.). Other Information Initial location at Indianapolis/Carmel location. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Limited domestic and international travel ( Role requires ability to work in manufacturing and laboratory environments. As a manufacturing support function, the need for occasional evening or weekend support can arise. Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600. Full‑time employees also will be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including a 401(k), pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits, life insurance, death benefits, 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. EEO Statement 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. #J-18808-Ljbffr Initial Therapeutics, Inc.