Sr. Analytical Chemist - API Method Development

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: Sr.

Analytical Chemist - API Method Development

This Sr.

Analytical Chemist, API Analytical Development is responsible for the development and validation of analytical methods, establishment of control strategies, supervision of work carried out by CDMOs, and compilation of regulatory submission documentation.

As part of a diverse global team consisting of API, formulation, analytical, and packaging scientists, you will have the opportunity to use your technical and leadership skills to bring new chemical entities to market.

Your Responsibilities: 


* Serve as an Analytical SME for small molecule API development, lead the development of control strategy and set specifications that can be transferred into manufacturing and successfully registered globally


* Ensure adoption of state-of-the-art technologies and Quality by Design (QbD) development concepts in method development as well as adherence to quality standards


* Conduct troubleshooting work, perform forced degradation study, characterize API structure, and elucidate impurity structures


* Design and implement VICH compliant stability studies conducted by external partners, perform statistical analysis of analytical data


* Contribute to the compilation of analytical submission documentation for worldwide registrations including responding to technical questions from Health Authorities, optimize and defend Elanco marketed products


* Direct and oversee work conducted in CDMO, develop and maintain good business relationships with CDMO

What You Need to Succeed (minimum qualifications): 


* Education: PhD in a scientific discipline (e.g., Analytical Chemistry or equivalent) 


* Required Experience: A minimum of 3+ years of related experience in pharmaceutical industry


* Top 2 skills: Strong analytical expertise and rich lab experience in techniques such as HPLC/UPLC, LC-MS, NMR, GC, IR, UV. Familiarity with ICH/VICH guidelines and GMP regulations. 

 

What will give you a competitive edge (preferred qualifications): 


* Experience in plan...