Beschreibung
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...
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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 Manager Microbiology Laboratory (m/w/d)
Primary location is Alzey, Germany
Ability to travel (approximately 10-20 %)
Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.
The Microbiology Laboratory lead is primarily responsible for managing microbiology testing in support of Parental Manufacturing in the Alzey site.
Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
Ensure and enforce compliance with all cGMP procedures, Quality Systems and Good Documentation Practices in the microbiology lab.
Leading the laboratory personnel, give direction and set standards
Supervise the activities within the microbiology labs, including but not limited to:
Perform microbiological testing for commercial product;
Manage analysis of EM samples
Managing of external testing activities
Method Verification according to pharmacopoeia guidelines
Participate in flow teams and process teams to ensure smooth collaboration with other departments;
Change management, Deviation management, Laboratory Investigations;
Organizing the lab following lean principles;
Ensure all the Analysts/Technician within the lab are properly trained.
Build and maintain working relationships with microbiology testing labs across the Lilly network.
Oversee QC laboratory equipment setup, qualification and operation
Support regulatory submission and inspections.
Masters degree or Bachelor’s (4-year) degree with extensive relevant work experience in a science field related to microbiology.
Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
Experience with microbiology testing
Previous experience with Laboratory IT systems such as MODA, LIMS and LES preferred
Leadership experience
Written and oral skills in German and English
Participated in Regulatory inspections such as EMA, FDA
Demonstrated knowledge and application of regulations as applicable to the pharmaceutical industry and related quality systems
Additional Skills/Preferences:
Management experience of third-party laboratories
Ability to mentor / train others, share learning
Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years...