(Archived) Sterility Assurance Lead

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Why Work at Elwood? We Save Puppies!

Working at a monoclonal antibody start-up facility in Elwood, Kansas presents an exciting opportunity to contribute to cutting-edge research: Monoclonal antibodies are an innovative type of biologic drug that can target specific molecules in the body to treat a variety of diseases, including cancer and autoimmune disorders. Working at a start-up facility that is developing these drugs is an opportunity to be on the forefront of medical research and contribute to developing treatments that can have a significant impact on pets' lives. Our current product is a one-time injection that is 100% effective curing the deadly parvovirus in puppies!

The sterility assurance consultant will provide oversight and direct contributions to Sterility Assurance/Contamination Control Strategy deliverables of the manufacturing operations in the Biotech network, to guarantee that the production and analytical processes are carried out with appropriate Sterility Assurance standards, in alignment with Global procedures, GMP (Good Manufacturing Practices) and Regulatory expectations, as well as industry best practices.

Acting as a subject matter expert for Sterility Assurance and microbiology, this individual operates cross-functionally and in partnership with process teams in production and TS/MS (Technical Services/Manufacturing Science) to improve the site Sterility Assurance related processes and programs (aseptic training/qualification, APS (Aseptic Process Simulation) program, EM (Environmental Monitoring) program, etc.).

Job Responsibilities:

• Provide technical and SME input in one or more programs including Process Validation, Aseptic Validation, Cleaning Validation and developing and owning the CCS.
• Maintain lifecycle documentation (e.g., validation plans)
• Author and develop Elanco EFP (Elanco Functional Procedures) supporting Contamination Control, sterile and aseptic process/ cleaning, and disinfection validation plans for the site.
• Work closely with area owners and suppliers to finalize validation/qualification requirements for facility, process, equipment, and systems, ensuring that company policies, procedures, applicable regulations, best practices, and guidelines are adhered to.
• Assist in troubleshooting, performing gap and risk assessments, provide support to regulatory inspections and conduct training as required.
• Provide oversite during execution of (re)validation/qualification of product manufacturing, aseptic processing (media fill), media holds, and sterilization (steam) cycles.
• Support corrective actions including investigating and ensure proper RCI (root cause Investigation/Analysis) and CAPA definition/effectiveness in resolving deviations as relevant to sterility assurance.
• Develop and perform OJT’s (on-the-job training) and classroom training of operators and technicians (Ops/Mtn/QC) for SA best practices as required.
• Enhance and expand training program to the next level of maturity as a comprehensive and integrated learning management program.
• Support audit preparation and defend areas of sterility assurance responsibility as a SME.
• Review site change controls to ensure the qualified/validated state of a process is not impacted by a proposed change.
• Ensure SA requirements/best practice are considered at all steps (from URS to qualification/validation) during CapEx (Capital Expenditure) projects.
• Lead the implementation of CI (continuous improvement) projects and other RFT (right first time) initiatives to reduce process risk, optimize plant and process productivity.

Minimum Requirements:

• B.S.in microbiology/biology or other related life science degree.
• 5+ years minimum experience with sterile manufacturing.
• Experience with a variety of technologies and platforms is preferred such as recombinant protein platforms, protein-based therapeutics, cell culture and fermentation technology.
• Proven experience with risk assessments and remediations implementation.
• Familiarity with Global Regulatory Standards FDA (Food and Drug Administration), EU (European Union) GMP, USDA (United States Department of Agriculture), CFIA (Canadian Food Inspection Agency), as applicable.
• Proven organization and time management skills to meet time sensitive deadlines, attention to detail, and collaboration in a team based environment are essential.
• Experience with upstream production of monoclonal antibodies (mAB) is highly preferred.
• Ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple projects simultaneously.

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Elanco 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