Scientist​/Principal Scientist – TSMS PAR

Company Overview

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. Our 39,000 employees worldwide work to discover and bring life‑changing medicines, improve disease understanding and management, and give back to communities through philanthropy and volunteerism. We give our best effort to our work and put people first.

The Scientist – TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual inspection (VI), although may support multiple areas during the start‑up phase. Upon commercial production start, the role’s objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods, harmonizing control strategies across process teams, evaluating process improvement, and serving as an escalation point for day‑to‑day operations issues.

The role will also author and execute protocols as well as conduct root‑cause investigations, provide technical leadership for the Parenteral Process Team, mentor within the TSMS team, and engage in upstream and external activities related to parenteral manufacturing.

• 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 Lilly Kenosha County TSMS team for internal and external communications on a regular basis.
• Lead risk management activities as it pertains to product/process.
• Provide technical support to non‑routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
• Prepare and review or approve technical documents such as Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.
• Develop, monitor, and appropriately react to established statistically based metrics in real time to assess process variability and capability.
• Identify opportunities and lead technical projects to improve process control and/or productivity.
• Serve as interface with upstream suppliers and parenteral product networks.
• Drive stability strategy for Lilly Kenosha County products.
• Provide audit support as needed.
• Identify opportunities and participate in projects to improve process control and/or productivity.

• Bachelor's degree or higher in engineering, packaging science, or related field.

• 2+ years experience in cGMP manufacturing preferred (validation, engineering, TSMS, operations, QA, etc.).
• Pharmaceutical and/or medical device manufacturing experience.
• Root Cause Investigation experience.
• Proficiency with computer systems including Microsoft Office, Veeva Vault, Track Wise/Master Control, electronic batch records, and SAP.
• Demonstrated successful leadership of cross‑functional teams.
• Strong interpersonal and teamwork skills.
• Strong self‑management and organizational skills.

• Role is Monday through Friday. Must be flexible to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and/or off‑hour work may be required.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 – $167,200. Full‑time employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program including a company‑sponsored 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).

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