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 5+ 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 planning, designing, and evaluating ICH/VICH registration stability studies and compilation of CMC submission documentation for animal or human health products.
• Proficiency in using LIMS, Empower, JMP etc.
• Work experience in long-acting injectable drug development, API solid state property characterization, and/or overseeing CDMO
• Strong organizational and leadership skills, with the ability to lead and inspire a team to deliver results with scientific excellence.
  
  

Additional Information:

• Travel: Approximately 10% annually
• Location: Global Elanco Headquarters - Greenfield, IN (NEW HQ COMING IN Q1 2025 Indianapolis, IN)
  
  

Don’t meet every single requirement? Studies have shown underrepresented 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 Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching
  
  

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