Associate Methods Specialist

Methods Specialist

Join us in shaping the future of animal health. For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

As a Methods Specialist, you will be part of a world-class team, contributing directly to the production and testing of veterinary products that improve animal health and welfare globally. You will collaborate closely with Quality Control, Manufacturing Operations, Bioprocess Technology Solutions, Regulatory Affairs, Statistics, and Analytical Technology Solutions across US sites to align priorities, expectations and deliverables. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence.

Because when it comes to animal health, no one sees it like we do.

Role Responsibilities:

• Support complex data analysis and trending to identify non-robust or out-of-specification methods. Conduct biomaterials assessments, inventory reviews, and document gap analyses to support remediation actions.
• Perform bench-level remediation across multiple test platforms, including live bacterial and virus titration/identification and ELISA for complex multivalent vaccines and in-process materials, working under guidance from senior team members.
• Author method remediation protocols, validation reports, and regulatory submissions for USDA review and approval with oversight from senior staff; update internal and regulatory procedures as required.
• Support post-remediation activities such as change control assessments and verification of sustained method performance.
• Participate in and, when appropriate, lead cross-functional teams for site-to-site analytical method transfer project work, coordinating tasks, timelines and deliverables with support from senior staff.
• Perform gap assessments of site capabilities – technical skills, instrumentation, and laboratory operations – and help implement remediation or training plans to enable successful transfers and ongoing performance.
• Provide hands-on training during method transfers (technical execution and instrumentation use) and oversee transfer documentation protocols, validation reports and supporting documents with support from senior staff.
• Support post-transfer monitoring and support to confirm method robustness and to resolve residual issues.
• Collaborate closely with Quality Control, Manufacturing Operations, Bioprocess Technology Solutions, Regulatory Affairs, Statistics and Analytical Technology Solutions across US sites to align priorities and expectations.
• Use internal project management systems to track progress, manage risks and report metrics with guidance from senior staff.
• Present technical updates, findings and recommend risk mitigations at team and regional meetings as needed.

Education Minimum Requirement:

• Bachelor's Degree in Biology, Genetics, Immunology, Microbiology, Virology, or a related biological science.

Required

Experience and Skills:

• 1-3 years hands-on bench experience with an emphasis on in vitro bioassay development, testing and troubleshooting.
• 1-3 years of experience in animal health environments (Quality Control, R&D and/or Technical Support), with familiarity with USDA regulations and requirements.
• Developing subject matter expertise in at least one bioassay platform (e.g. ELISA, virus titration, HA/HI).
• Developing skill sets in bioassay data analysis, trending and interpretation.
• Strong technical writing skills with ability to learn how to prepare protocols, reports and related laboratory documentation.
• Effective communicator with experience collaborating across functions.

Preferred

Experience and Skills:

• Experience performing or troubleshooting analytical methods for complex animal health vaccines and in-process materials.
• Capability to learn how to design and develop methods to meet USDA regulatory expectations.
• Practical knowledge of bioassay experimental design.
• Familiarity with analytical technologies such as imagers and liquid handlers.
• Experience…