Subject Matter Expert Analytical Development, Small Molecule Technical Development (SMTD) (m/f/d)

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!

The Subject Matter Expert Analytical Development directly supports Elanco’s Technical Development (TD) organization and reports to a team leader of Analytical Development SMTD.

This position is responsible for analytical development activities of animal health products and related activities associated with the development of animal health products.

As part of technical development teams, the role is expected to support drug development with a diverse range of responsibilities.

These responsibilities include analytical development activities from the pipeline entry to regulatory approval: Quality by design development and optimization of analytical methods including dissolution as well as validation and release analytics in compliance with industrial (GxP) and regulatory requirements (VICH/ICH) are focus areas of this role.

In-depth scientific analytical expertise and communication skills are expected for partnering with manufacturing and regulatory representatives to successfully drive drug product commercialization activities and technical submissions to global health authorities.

The Subject Matter Expert will take on responsibility of problem solving for questions related to analytics, cooperating within interdisciplinary and international teams and support ensuring launch readiness for analytical activities including transfer of methods to commercial organizations.

This role will also be responsible for driving evaluation and implementation of new technologies in the field of analytics, applying the latest scientific thinking in analytical testing to help bring new drug products to market.

Responsibility for analytical control strategy, identification of future capability needs, support of identification and selection of Contract Research/Development/Manufacturing Organizations (CRO/CDMO) and technical oversight of CRO/CDMO development work are also crucial part of the role.

The acceptable candidate should have relevant experience in authority interactions within technical sections of dossier submissions focusing on oral solid dosage forms and o...