Eli Lilly is seeking a Sterility Assurance Advisor for their new facility in Alzey, Germany. This role focuses on technical leadership in sterility assurance for parenteral products, emphasizing safety, compliance, and continuous improvement
Job Summary
The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: reliable, compliant manufacturing of the drug product; improvement of the process control strategy, continuous optimization, development and the innovation of technologies; and continual deepening of the scientific understanding of sterility assurance.
A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs.
The Steward level scientist provides leadership and influence across the Parenteral Network and represents and defends the site’s sterility assurance programs during internal audits and external regulatory inspections.
Matching Summary
Match Score: 85
Eli Lilly is seeking a Sterility Assurance Advisor for their new facility in Alzey, Germany. This role focuses on technical leadership in sterility assurance for parenteral products, emphasizing safety, compliance, and continuous improvement.
Skills & Requirements
Must-have
sterility assurance programs
parenteral drug products
aseptic process simulation
contamination control strategy
risk management programs
Nice-to-have
facility start-up experience
technical transfer experience
leadership and influence
Key Requirements
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
Minimum 7 years’ experience in the biopharmaceutical industry
In depth knowledge and understanding of GMPs and internal standards
In depth knowledge of parenteral processing
In depth knowledge of microbiology and sterility assurance
In depth knowledge of risk management and the understanding / ability to use risk assessment tools