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 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Purpose: The Lifecycle Innovation group in GRA-CMCD is responsible for ensuring Eli Lilly and Company develops and executes effective post-approval CMC regulatory strategies across its global commercial portfolio. The group drives lifecycle regulatory excellence by supporting manufacturing sites, enabling process simplification, accelerating submission efficiency, and applying innovative digital and regulatory approaches to post-approval change management. The purpose of the Sr. Principal Scientist/Advisor/Sr. Advisor role is to provide strategic, tactical, and operational direction in support of Lilly's marketed portfolio by developing successful regulatory strategies and submissions globally. To accomplish this, the scientist develops collegial and mutually productive relationships with CMC customers, including personnel within pharmaceutical manufacturing sites (e.g., Manufacturing Science and Technology, Quality Assurance, Production, Supply Chain), bulk manufacturing sites, and contract manufacturers whose material is used in Lilly products. The scientist utilizes CMC technical knowledge, regulatory expertise, and lessons learned across GRA-CMCD to drive internal consistency, influence effective change management, and contribute to lifecycle innovation and continuous improvement initiatives.
Primary Responsibilities:
Minimum Qualification Requirements:
Other Information/Additional Preferences:
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 for further assistance.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Tagged as: Life Sciences
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