Material Expert – MSAT (m/f/d)

350 Lilly Deutschland GmbH; Alzey; Vor Ort; EUR 60.000 - 121.000; Vollzeit

Zusammenfassung

Lilly Deutschland GmbH is building a high-tech parenteral site in Alzey, Rheinland-Palatinate, to expand injectable medicines production from 2027. The role sits in the TS/MS (MSAT) team, owning materials & component qualification, supplier changes, and process robustness.

Global site leadership visibility and cross-site collaboration are expected. The role emphasizes technical expertise in materials, CCI, and regulatory support, with strong emphasis on safety, quality, and GMP compliance across

Qualifikationen

• GMP knowledge and manufacturing process understanding.
• Strong data analysis and problem-solving skills.
• Excellent collaboration and interpersonal abilities.

Aufgaben

• Maintain safe work environment and support HSE goals.
• Provide SME input on materials, CCI topics, and regulatory support.
• Lead/assist projects to improve material quality, yield, and process robustness.
• Prepare and review technical documents and changes for regulatory submissions.

Kenntnisse

GMP knowledge

Data analysis

Collaboration

Problem solving

Ausbildung

BS or MS in Microbiology, Biochemistry, Biology or Chemical/Biochemical Engineering

Tools

Container Closure Integrity testing

Jobbeschreibung

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.

Key Objectives / Deliverables:

• 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 protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
• Provide manufacturing input on regulatory submissions and other pertinent regulatory topics related to product contact materials and container closure.
• Support risk management activities as it pertains to materials and components.
• Serve as technical interface to the Lilly TSMS network.
• Act as SME during audits on all topics related to materials.

Expected Qualifications:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Good understanding of GMP and manufacturing processes
• Experience with material criticality assessments and specification management
• Strong interpersonal and collaboration skills
• Ability to analyses complex data and solve problems
• Fluent in German and English

Additional Preferences:

• Familiar with Container Closure Integrity concepts and testing
• Experience with elastomer components and glass container (failure modes, testing, product interactions, specifications)
• Experience with project start-ups and process implementation
• German language skills can help in this role

What to consider:

Role is Monday through Friday site-based (Alzey) with the ability to travel to Indianapolis and other global Lilly sites as required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is €60.000 - €121.000 Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain 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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.

How do we do this?

We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly