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Elanco Tiergesundheit AG in Indianapolis, IN, is seeking a Senior Research Scientist in Analytical Development to advance analytical and dissolution strategies for small molecule programs. You will support a diverse drug development pipeline and ensure global regulatory compliance.
Responsibilities include method development, data interpretation, technical leadership, and authoring regulatory submissions. The role requires strong leadership, collaboration across international teams, and
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!
As a Senior Research Scientist in Analytical Development, you will be a key scientific leader on our Technical Development (TD) team, directly contributing to Elanco's mission by advancing the analytical and dissolution control strategies for our small molecule portfolio. In this role, you will be responsible for supporting our drug development pipeline through a diverse range of analytical activities, ensuring our new animal health products meet global quality and regulatory standards.
Develop, validate, and deliver robust analytical and dissolution methods and specifications, while driving the evaluation and implementation of new technologies to advance our drug development process. Interpret complex scientific data, draw relevant conclusions, and effectively report and present technical results to internal teams and at external scientific conferences. Author and support the generation of international registration documents, partnering with manufacturing and regulatory colleagues to drive drug product commercialization and technical submissions to global health authorities. Mentor and coach emerging technical talent within the analytical development function, fostering a culture of scientific excellence. Ensure all activities are compliant with internal and external quality standards and guidelines, including GxP, SOPs, and HSE.
PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field with a minimum of 5 years of experience in pharmaceutical development; M.S. in a related field with a minimum of 10 years of experience; or B.S. in a related field with a minimum of 15 years of experience.
Strong expertise in chromatographic (HPLC/UPLC), spectroscopic (UV/VIS), and dissolution method development (specifically with USP Apparatus II and IV).
Extensive knowledge of current quality and regulatory requirements for new drug products and a demonstrated track record of successful interactions with regulatory agencies (e.g., FDA/CVM, EMA) on analytical topics.
Significant experience in dissolution development and regulatory submissions. Experience with mass spectrometry (MS) and other areas of analytical method development. Proven scientific leadership skills combined with strong problem-solving and creative thinking abilities. Demonstrated ability to collaborate and positively impact interdisciplinary and international teams. Experience working in regulated environments (e.g., GMP).
Travel: 10% Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment
At Elanco we are dedicated to building a diverse and inclusive work environment.
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.
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.