Senior Principal Scientist – Sterility Assurance – Technical Services/Manufacturing Science (m/w/d) Full-time

Senior Principal Scientist – Sterility Assurance – Technical Services/Manufacturing Science

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.”

The role is a technical position that develops and implements the site's sterility assurance related initiatives and provides technical leadership regarding sterility assurance strategies.

Primary objectives include building a team to support the start-up and compliant manufacturing of Concord products, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management. The scope of the role includes syringe filling operations for commercially manufactured products targeted for transfer to the Concord site.

What tasks await you?

• 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 the chemistry, equipment, aseptic processes, and container closure systems.
• Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
• Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk.
• Provide technical support for all start-up activities related to sterility assurance programs (e.g., airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
• Ensure site's environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level.
• Provide technical guidance to the Process Team for sterility assurance programs and for root cause investigations related to sterility assurance programs.
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• 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 to remain current with regulatory expectations and industry trends.
• Participate in continuous improvement projects to improve quality performance at the site.
• 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 a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
• Serve as sterility assurance interface external to the Concord site.
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

How do you convince us?

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Prior experience in cross functional technical leadership roles.
• In depth knowledge of parenteral drug product manufacturing, with a focus on Sterility Assurance
• 5+ years supporting cGMP manufacturing (specifically within 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 that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Facility start-up 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

What can you look forward to with us?

• Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years.
• Innovation: You will work in a medical high-tech production facility equipped with the most advanced technology.
• Creative freedom: From the beginning, you will have the freedom to contribute your ideas and implement them in cross-functional teams.
• Development: We value the individual career development of our employees and ensure fair access to professional development worldwide through our “Corporate Lilly University.”
• Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.
• 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.