Senior Principal Scientist – Sterility Assurance - MSAT; m​/w​/d

Position: Senior Principal Scientist – Sterility Assurance - MSAT (m/w/d)
Location: Germany

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."
** Join our Lilly team in Alzey and start as soon as possible as:
**** Senior Principal Scientist – Sterility Assurance - Technical Services/Manufacturing Science (m/w/d)
** 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 objective s include building a team to support the start-up and compliant manufacturing of Alzey 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 Alzey 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 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…