Material Expert – MSAT; m​/f​/d

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.

Titel:
Sr. / Principal Material Expert – MSAT (m/f/d)

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.

At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People."

In this role you will be part of the TS/MS (Technical Services / Manufacturing Science) team (also known as MSAT or MS&T). The TS/MS team is the technical owner of the process — from tech transfer and validation through commercial lifecycle management. Our decisions on control strategy, lifecycle, and process robustness shape how this greenfield parenteral site runs for the next decades, with direct visibility to site leadership and Lilly's global technical network.

• Responsible for maintaining a safe work environment, working safely and accountable to support all HSE corporate and site goals.
• Act as a site subject matter expert and provide deep scientific and technical expertise for high-risk materials (including primary/critical secondary packaging components), raw materials, and GMP consumables used in the drug product manufacturing process.
• Understand, justify, and document the state of qualification of components with data that evaluates the capability of the manufacturing process to meet its stated purpose.
• Evaluate the impact of changes at suppliers to the product/process.
• Lead/support technical projects to improve process control, capacity, quality, yield, and attribute measurement as related to materials and components.
• Act as expert for Container Closure Integrity topics and own related investigations and improvement projects.
• Perform Extractable and Leachable Assessments for new products and related manufacturing materials.
• Establish and maintain technical documents and specifications for materials and components.
• Create, maintain, and perform applicable periodic review of materials and consumables.
• Provide technical support for all start-up activities (e.g. tech transfer, process validation, change controls, deviations).
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation…