Advisor – Feed Additive Assay & Generic Defense

Role Summary

Advisor – Feed Additive Assay & Generic Defense. As Advisor – Feed Additive Assay & Generic Defense, you will lead Elanco’s testing strategy for feed additives (assays) and our defense against generic competitors. This role ensures our feed products are tested correctly and consistently, and coordinates efforts to protect their value against generic versions.

Responsibilities

• 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.

Responsibilities

• 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.

Responsibilities

• 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

• Education: Bachelor‚Äôs degree in a science field (e.g., chemistry, pharmaceutical sciences, animal science).
• Experience: Minimum 8 years of experience in analytical testing or quality within animal health or pharmaceutical industries.
• Top laboratory skills include hands-on experience with laboratory methods for complex samples (feeds), including HPLC/UPLC and LC‚ÄìMS, proven experience in building and transferring methods across multiple laboratories and partners. Leadership skills include solid project management and the ability to drive cross-functional initiatives with clear communication skills, capable of simplifying technical topics for non-technical teams.

Education

• Bachelor‚Äôs degree in a science field (e.g., chemistry, pharmaceutical sciences, animal science).

Additional Requirements

• Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment