Advisor – Feed Additive Assay & Generic Defense

Role Summary

Advisor – Feed Additive Assay & Generic Defense leads Elanco's testing strategy for feed additive assays and defends against generic competition. The role ensures feed products are tested correctly and consistently, and coordinates cross-functional efforts to protect their value against generic versions.

Responsibilities

• Assay Leadership (How We Test Our Feeds): Own the testing strategy for all feed additive products across Elanco sites and partners. Build and maintain robust laboratory methods (develop, validate, document, and update). Set clear testing limits and pass/fail criteria, ensuring adherence by all labs. Standardize tools and methods (e.g., HPLC/LC-MS) for consistent results across laboratories. Lead method transfer and proficiency testing between Elanco labs and contract labs. Ensure methods are "inspection-ready" and easily updated for continuous improvement.
• Generic Defense (Protecting Our Products): Lead cross-functional plans to defend key products when generic competition is anticipated. Collaborate with Regulatory, Legal/IP, Quality, and Marketing to plan studies and strategies that protect market position. Monitor the competitive landscape to predict potential generic entry. Coordinate global plans to ensure timely and synchronized US and EU submissions and renewals.
• Regulatory and Cross-Functional Teamwork: Partner closely with Regulatory teams on study protocols and submissions. Align with Legal/IP on competitive intelligence and defense tactics. Work with Manufacturing and Quality to maintain strong testing practices across all sites. Represent Elanco with external laboratories and industry groups as needed.

Qualifications

• Required: Education: Bachelor’s degree in a science field (e.g., chemistry, pharmaceutical sciences, animal science).
• Required: Experience: Minimum 8 years of experience in analytical testing or quality within animal health or pharmaceutical industries.
• Required: Skills/Competencies: Hands-on experience with laboratory methods for complex samples (feeds), including HPLC/UPLC and LC–MS; proven experience in building and transferring methods across multiple laboratories and partners; solid project management and the ability to drive cross-functional initiatives with clear communication, capable of simplifying technical topics for non-technical teams.
• Preferred: Master’s degree in a science field (e.g., chemistry, pharmaceutical sciences, animal science) and/or >10 years of experience.

Education

• Bachelor’s degree in a science field (e.g., chemistry, pharmaceutical sciences, animal science)
• Master’s degree in a science field (preferred)

Additional Requirements

• Travel: approximately 20%
• Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment
• A minimum of 30 days/quarter required in the home office