Sr. Analytical Scientist, API Characterization 

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 Scientist, API Characterization 

As Sr.

Analytical Scientist, API Characterization, you will be a vital part of our global team, contributing to the advancement of new chemical entities to market through your expertise in analytical method development and validation. 

Your Responsibilities: 


* Lead technical efforts in small molecule API analytical development, enabling the design, development, and implementation of analytical methodologies for small molecule characterization and analysis, including peptides. 


* Establish analytical control strategy and specifications for API that can be transferred into manufacturing and successfully registered globally, requiring cross functional collaboration with manufacturing, development, and regulatory affairs 


* Oversee the development and validation of analytical methods in third-party organizations, ensuring adherence to quality standards. 


* Design and implement VICH-compliant stability studies conducted by external partners. 


* Author analytical submission documentation and coordinate the CMC sections of dossiers for worldwide registrations, including responding to technical questions from Health Authorities. 


* Serve as the Analytical Subject Matter Expert for global project development teams. 


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

 

What You Need to Succeed (minimum qualifications): 


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


* Required Experience: A minimum of 5+ years of related experience in industry 


* Top 2 skills: Strong understanding of pharmaceutical analytical chemistry and analytical techniques, such as HPLC/UPLC, NMR, SSPC, GC, IR, UV.

Familiarity with ICH and/or VICH guidance and GMP regulations. 

 

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


* Experience in planning, designing, and evaluating Health Authority registrat...