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
The Vaccine Network Analytical Steward functions as a Global Quality Control Network for internal and external vaccine quality control labs, providing support for analytical topics and technical issues
Functions, Duties, Task:
Provides technical oversight to the successful commercialization of new products through specification setting and method transfers. This will involve strong partnering with analytical development, site QCL and potential third party laboratories.
Develop and maintain a network assay monitoring program to ensure that analytical control strategies are continually capable of supporting manufacturing needs.
Develop and drive and in-vivo to in-vitro conversion road map to improve analytical capabilities and support the 3Rs initiative through replacement and reduction.
Provide technical leadership and oversight to the vaccine QC and AS&T networks to establish knowledge transfer, establishment and communication of best practices, review of compliance or regulatory changes, and provide a forum for troubleshooting
Actively partner with the vaccine TS/MS network to ensure analytical improvement projects are aligned with and supports network manufacturing goals.
Assist the vaccine site QC laboratories with investigations and method issues by providing technical guidance and connecting the site with additional resources in the network. The scope of the role includes animal, biologic, microbiological, and chemistry methodologies.
Provide consultation/recommendation to the Elanco vaccine network organization on various analytical topics, including method development and improvements, approaches to troubleshooting significant analytical technical issues, references, compendial and regulatory initiatives.
Implementation of new technologies into the QC labs and improvement of existing methodologies.
Interact with other appropriate laboratories (Analytical Development, QCL, Third Party) and manufacturing personnel for development, training, transfer or validation of methodologies or new technologies.
Coordinate non-routine analytical work and samples analysis to support relevant projects and initiatives (e.g. process improvements, method development, validation, transfers)
Bachelor or Masters degree in Biology, Microbiology, Biochemistry or related field
Minimum of 5 years experience working with GMP or USDA vaccine or biologics analytical laboratory or similar regulated environment with emphasis on biological or microbiological assays
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.
Demonstrated leadership ability to direct a group of scientists to produce satisfactory solutions to business partners
Demonstrated ability to consistently exercise independent judgment and decision making
Demonstrated ability to work with both development and commercial environments, including ability to interpret and bridge between quality and regulatory requirements of each
Previous experience with third party manufacturers or laboratories
Experience with Animal Health Products and Regulations
Demonstrated ability to work across sites, functions and cultures
Ability to influence diverse groups and effectively manage relationships
Experience in an analytical lab in a related field, such as medical microbiology
25-50% travel required, some international travel.
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