Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 6,000 employees worldwide. Our worldwide headquarters and research facilities are in Greenfield, Indiana, and we have regional R&D hubs in Australia, Brazil and Europe.
Position Description The Principal Research Scientist will manage safety activities in defined team projects, most normally but not exclusively, those activities related to environmental safety in farmed fish medicines. The Principal Research Scientist will ensure optimal output from associates within Elanco, and contractors, assigned to support the experimental programs and ensure that requirements for project plan timelines, budgets, risk management and GLP are met, and Standard Operating Procedures are observed. Additionally, the Principal Research Scientist is available to provide expert advice and guidance to other project teams on study design, experimental conduct, data interpretation and documentation. The Principal Research Scientist may also provide advice and guidance on marketed veterinary medicinal products and provide specialist assessments for commercial business units and their customers. The Principal Research Scientist will participate in appropriate Community of Practice groups, will mentor junior Safety scientists within the Elanco business and represent Elanco at meeting with industry and regulators.
Functions, Duties, Tasks:
Define, plan and lead activities related to safety (most normally environmental safety) during new product development and for marketed veterinary medicinal products.
Develop and maintain superior expert knowledge in the area of environmental safety.
Devise, plan, monitor and coordinate safety-related studies, review reports and ensure compliance with regulatory needs in consideration of external and internal guidelines (e.g. Quality, Standard Operating Procedures, GLP, HSE and animal welfare). Interpret data and draw relevant conclusions.
Prepare and maintain Environmental Safety Expert Reports or similar related documentation for international regulatory submissions. Support and defend dossiers and negotiate critical issues related to safety with regulatory authorities.
Contribute to the optimization of project related scientific/technical activities and processes within the Safety function. Develop and evaluate new scientific technologies, platforms and procedures.
Contribute to the planning and conduct of efficacy studies.
Participate, as a technical expert, in industry groups including those mandated to write international guidelines, position papers and other related documents.
Mentor junior scientists within the Elanco business.
Perform other such related and reasonable duties as may be required by Elanco from time to time and that are within capabilities.
PhD or equivalent with minimum 10 years’ relevant experience in environmental safety. Experience in the development of fish medicines is a plus.
Recognized scientific/technical expertise in a specific safety-related area and a broader scientific and strategic background.
Able to understand and interpret data from relevant documents to assess environmental safety.
Keep up-to-date on national and international regulatory requirements. In depth knowledge of GLP.
Proven track record of creativity, problem solving and productivity in projects.
Broad and in-depth understanding of research and development processes.
Excellent presentation skills and scientific/technical writing skills.
Demonstrated successful experience in working in interdisciplinary teams.
Demonstrated scientific leadership skills in solving highly complex or high-risk project/technical issues.
Demonstrated effective communication skills being able to adapt style to suit specific audiences.
Demonstrated Values and Behaviors expected within Elanco.
Appropriate years of experience in a related research environment, and scientific and entrepreneurial thinking.
Travel requirements: approx. 10 – 20% Location: based in Basel (Switzerland) or Greenfield (USA)