Principal Research Scientist - Analytical Development Synthetic Technical Development

• • Significant experience with dissolution development and preparing regulatory submissions.

  • Experience working in regulated environments (e.g., GMP).

  • Proven scientific leadership skills.

  • Strong collaborator with the ability to positively impact interdisciplinary and international teams.

  • Strong problem-solving skills, including strategic and creative thinking.

  • Experience in analytical method development in areas outside of dissolution.

  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

  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.

As the Principal Research Scientist, Analytical Development, you will support Elanco’s Technical Development (TD) organization. This position is broadly responsible for analytical development activities of animal health products with a concentrated expertise in dissolution control strategy and synthetic molecule analytical development. As part of technical development teams, the role is expected to support drug development with a diverse range of responsibilities.

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  Develop and deliver relevant analytical and dissolution methods and specifications, ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH).

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  Interpret results, evaluate data, and draw relevant conclusions.

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  Report and present scientific/technical results internally, create external publications, and present at scientific conferences.

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  Write or support the generation of international registration documents and interact with global health authorities.

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  Partner with manufacturing and regulatory representatives to drive drug product commercialization activities and technical submissions to global health authorities.

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  Drive the evaluation and implementation of new technologies in dissolution and analytical development, applying the latest scientific thinking to help bring new drug products to market.

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  Mentor and coach emerging technical talent within the function.

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  Ensure compliance with external and internal guidelines/quality standards (e.g., SOPs, GxP, HSE, and Animal Welfare).

• Extensive knowledge of current quality and regulatory requirements for new drug products.

• Demonstrated track record of interacting with regulatory agencies (e.g., FDA/CVM, EMA) on analytical topics.