Scientist à Allemagne

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 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 look for people who are determined to make life better for others.

At Lilly in Germany, we are planning and building a high-tech production facility in Alzey (Rhineland-Palatinate) to expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To support the site, we are seeking motivated professionals who will help ensure the supply of Lilly medicines in Germany, Europe, and worldwide, aligned with Lilly values: Excellence, Integrity, and Respect for People.

The role is a technical position that develops and implements the site’s sterility assurance initiatives and provides technical leadership on sterility assurance strategies. Primary objectives include building a team to support startup and compliant manufacturing of Concord products, focusing on development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, sanitization, and sterility assurance risk management. The scope includes syringe filling operations for commercially manufactured products transferred to the Concord site.

• Provide leadership to TS/MS organization for technical and administrative issues.
• Performance management and development of staff.
• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Use sterility assurance risk management to evaluate proposed manufacturing processes and controls for potential microbial, endotoxin, and particulate contamination.
• Assist in developing and executing process and facility monitoring strategies focusing on areas of highest microbial risk.
• Provide technical support for startup activities related to sterility assurance programs (e.g., airflow pattern testing, environmental monitoring PQ, aseptic process simulations).
• Ensure site environmental monitoring, aseptic process simulations, facility cleaning, sanitization, sterility assurance risk management, and related programs are followed on the manufacturing floor.
• Provide technical guidance for sterility assurance programs and root cause investigations.
• Analyze microbial and manufacturing data using statistical principles to identify trends and opportunities for continuous improvement.
• Perform periodic review of environmental monitoring data.
• Lead or support risk assessments related to sterility assurance programs.
• Create, execute, review, and/or approve technical documents related to sterility assurance programs.
• Create, execute, and/or evaluate change controls related to sterility assurance programs.
• Continually educate self and others to drive improvements and stay current with regulatory expectations and industry trends.
• Participate in continuous improvement projects to improve site quality performance.
• Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs.
• Support and/or lead TS/MS technical projects to ensure startup success, improve process control, yield, product quality and productivity; implement process changes through the technical agenda.
• Serve as sterility assurance interface external to the Concord site.
• Work within or lead cross-functional teams to implement TS/MS objectives and deliver on business and quality goals.
• Collaborate with and influence partners across the Parenteral Network and product supply chains.
• Maintain a safe working environment through compliance with safety rules and active participation in safety activities.

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
• Prior experience in cross-functional technical leadership roles
• In-depth knowledge of parenteral drug product manufacturing with focus on Sterility Assurance
• 5+ years supporting cGMP manufacturing (operations, environmental monitoring, sterility assurance, validation, microbiology, TSMS, QA, etc.)
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Strong oral and written communication skills for all levels of the organization
• Facility startup and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
• Demonstrated successful leadership of cross-functional teams
• Experience with data trending and analysis; ability to analyze complex data and solve problems

• Pioneering spirit: Growing team up to 1,000 colleagues over the next three years
• Innovation: Work in a medical high-tech production facility with advanced technology
• Creative freedom: Contribute ideas and implement them in cross-functional teams
• Development: Commitment to individual career development through Lilly University
• Financial benefits: Attractive salary and company pension plan plus other benefits
• Application: Please apply online with complete documents through our applicant portal

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. The form is available at: https://careers.lilly.com/us/en/workplace-accommodation