Advisor – Feed Additive Assay & Generic Defense

Your Role

Advisor – Feed Additive Assay & Generic Defense

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.
• Carefully 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.

Requirements

• Education: Bachelor’s 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–MS, 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.

Preferred Qualifications

• Master’s degree in a science field (e.g., chemistry, pharmaceutical sciences, animal science) and/or >10 years of experience.

What will give you a competitive edge

• Additional education or experience in regulatory affairs, legal/IP, or marketing.
• Experience working with international regulatory bodies.
• Strong background in data analysis and statistical methods.

What You Need to Succeed

• Education: Bachelor’s 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–MS, 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.

Additional Information

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