API Manufacturing Science & Technology Manager (m/w/d)

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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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 5 years in API manufacturing with knowledge of cGMP requirements for drug substance/product manufacturing.

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

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

• PhD in Chemistry or Chemical Engineering.

• Experience in API process development, technology transfer, validation, and commercialization.

• Knowledge of multiple technology platforms (small/large molecule, material science, oral solid dose, premixes).

• Experience with continuous improvement, deviation management, and regulatory requirements (EDQM, CVM).

• Proficiency in statistical tools (JMP, Minitab), quality document systems (e.g., Veeva), and AI-enabled technical tools.

Additional Information:

• Travel: 15–25% to global contract manufacturing sites.

• Location: India Mumbai

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status