API Manufacturing Science & Technology Manager

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Manufacturing Science & Technology (MS&T) Manager – API

As the MS&T Manager (internally known as Technical Services / Manufacturing Science – TS/MS), you will be part of the Elanco External Manufacturing (EEM) Global API Hub team.

In this role, you will partner with Quality, Operations, Supply Chain, and R&D to ensure reliable, compliant, and cost-effective API manufacturing.

You will be responsible for supporting established products through their commercial lifecycle, providing technical oversight, driving process improvements, and supporting regulatory submissions.

Your Responsibilities:


* Serve as the primary technical resource for assigned API manufacturing processes and provide on-site support as needed.


* Lead technology transfer, process implementation, validation, and process improvements with focus on capability, compliance, cost, and regulatory impact.


* Review and author technical and manufacturing documents (MBRs/eBRs, PQRs, validation reports, change controls, regulatory support documents).


* Collaborate cross-functionally to troubleshoot manufacturing issues and support new product commercialization.


* Support API regulatory activities, geo-expansion launches, and contract manufacturer technical due diligence.

What You Need to Succeed (Minimum Qualifications):


* Education: Bachelor’s degree in Chemistry or Chemical Engineering, or equivalent experience.


* Experience: Minimum 10 years in API manufacturing with knowledge of cGMP requirements for drug substance/product manufacturing.


* Skills: Strong problem-solving, stakeholder management, analytical, and communication skills.


* Experience in API process development, leading technology transfer, preparation of validation documentations and manufacturing execution.

What Will Give You a Competitive Edge (Preferred Qualifications):


* PhD in Chemistry or Chemical Engineering.


* Knowledge of multiple technology platforms (small molecules, material science, oral solid dose, premixes).


* Experience with continuous improvement, deviation management, and regulatory requirement...