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

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better.

Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life.

Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

The Dissolution Expert Analytical Development directly supports Elanco’s Technical Development (TD) organization and reports to the Head of Analytical Development SMTD.

This position is broadly responsible for analytical development activities of animal health products with a concentrated expertise in dissolution control strategy.

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 dissolutions methods 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 dissolution 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 Dissolution Expert will take on responsibility of problem solving for questions related to dissolution, 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 dissolution, applying the latest scientific thinking in dissolution testing to help bring new drug products to market.

Responsibility for dissolution 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 dissolution of orals solid dosage forms and other formulation types e.g.

suspensions.

Responsibilities will include but are not limited to:


* Develop and deliver relevant dissolution methods and specifications.


* Interpret results, evaluate data and draw relevant conclusions.


* Report and present scientific/technical results internally, may create external publications and patents and may present at scientific con...