Lilly Consultant-TS/MS Sterility Assurance in Fort Dodge, Iowa
Position Brand Description & Responsibilities:
In this role, you are critical to the success of Elanco’s Vaccine products manufacturing organization. As a Sterility Assurance Consultant, you are a key member on our team, and are responsible for providing technical and strategic stewardship of sterility assurance programs employed across the Vaccine Network. The Sterility Assurance Consultant will collaborate with cross-functional teams across Elanco and will work side-by-side with other scientists and professionals to drive the site and the Vaccine Network sterility assurance agenda.
Responsibilities will include developing and implementing targeted process improvements, as well as strategic-level transformations, to site sterility assurance programs. This role will also have a broad scope including all integrated aspects of the site sterility assurance programs. This position will lead and integrate initiatives that drive sterility assurance standards across multiple functions including Technical Services / Manufacturing Science (TS/MS), Environmental Monitoring, Operations, Engineering, and Quality Assurance.
Understand the scientific principles for manufacturing Vaccine Products, including the interaction of the chemistry, equipment, aseptic processes and container closure.
Use risk based approaches to evaluate existing manufacturing processes and associated controls with respect to the potential for microbial, endotoxin and particulate contamination and drive improvements across the network.
Providing technical expertise and supporting Elanco’s sites in Canada, Europe and the US on all sterility assurance aspects. Travelling to various sites including Larchwood, Cuxhavan, Winslow and PEI to support key remediation or process improvement efforts
Be an effective source of information and advice on sterility assurance and positively contribute to the Vaccine Network, ensuring that all sites maintain a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy.
Ensuring an effective sterility assurance and environmental monitoring program is deployed across the network.
Acting as a SME on sterility assurance for the Vaccine Network and as a primary Point-of-Contact for Regulatory Audits.
In depth knowledge of Aseptic processing
In depth knowledge of microbiology and the application toward aseptic processing.
Ability to analyze complex data and solve problems
Technical writing and presentation skills
Interpersonal skills including the ability to effectively influence others
Clear understanding of cGMPs
Root Cause Investigation experience
Ability to influence large diverse groups
Vaccine Manufacturing Experience
Lilly is an EEO/Affirmative Action Employer and 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.
Sterility Assurance Scientist
Bachelors Science in a scientific disciplines such as Biochemistry, Biology, Microbiology, Engineering
5 years experience in Aseptic manufacturing (Operations, TS/MS, Quality Control, Quality Assurance).
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
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