Scientist / Principal Scientist - TSMS PAR

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. We discover and bring life‑changing medicines, improve disease management, and give back through philanthropy and volunteerism. Responsibilities The Scientist – TSMS PAR will focus on parenteral operations, including technical transfer and process validation, and support formulation, filling or visual inspection (VI). In commercial production this role will maintain validated processes, establish and monitor metrics, harmonize control strategies, evaluate process improvements and act as an escalation point. The role will also author protocols, conduct root‑cause investigations, develop technical agendas, provide technical leadership to the Parenteral Process Team, mentor team members and engage in upstream and external activities. Key Objectives/Deliverables Support the assigned Process Team (formulation, filling, or VI) as TSMS representative. Serve as floor‑level support and technical interface for manufacturing components, equipment, and operations for the TSMS team. Represent the Lilly Kenosha County TSMS team for internal and external communications on a regular basis. Lead risk management activities related to product/process. Provide technical support for non‑routine investigations, including quality and stability consultations. Prepare and review or approve technical documents such as Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, and others. Develop, monitor, and react to statistically based metrics in real time to assess process variability and capability. Identify opportunities and lead technical projects to improve process control and productivity. Serve as interface with upstream suppliers and parenteral product networks. Drive stability strategy for Lilly Kenosha County products. Provide audit support as needed. Participate in projects to improve process control and productivity. Basic Qualifications Bachelor’s degree or higher in engineering, packaging science, or related field. Authorized to work in the United States on a full‑time basis. Lilly will not sponsor work authorization or visas for this role. Additional Skills/Preferences 2+ years’ experience in cGMP manufacturing (validation, engineering, TSMS, operations, QA, etc.) preferred. Pharmaceutical and/or medical device manufacturing experience. Root‑cause investigation experience. Proficiency with Microsoft Office, Veeva Vault, TrackWise/MasterControl, electronic batch records, and SAP. Successful leadership of cross‑functional teams. Strong interpersonal and teamwork skills. Strong self‑management and organizational skills. Additional Information The role is Monday through Friday. Flexibility is required to support production schedules and shutdowns; occasional extended or off‑hour work may be required. This job description is intended to provide a general overview of the job requirements at the time it was prepared. Duties may change over time and may include additional responsibilities not described here. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. 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. Our Employee Resource Groups (ERGs) offer support networks to all employees. Current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), and enAble (for people with disabilities). Learn more about all of our groups. 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 will also be eligible for company bonuses and a comprehensive benefit program, including 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible spending accounts, life insurance, and well‑being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion.

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