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!
Functions, Duties, Tasks:
Key Technical responsibilities:
- Provide statistical design and analysis supporting Process Development (including process development, process characterization, validation, and tech transfer/comparability)
- Provide statistical design and analysis supporting Analytical Development (including analytical development, qualification, validation, and method transfer/reproducibility)
- Perform analyses to support stability studies and shelf life/expiration dating.
- Assist the integration of Quality by Design principles into analytical and process development.
- Facilitate the use of statistical thinking and experimental design during technical development validation and transfer of new processes and analytical methods for active ingredients and products.
- Meet timelines for statistics deliverables.
- Effectively communicate statistical principles and approaches to associates without a statistical background.
- As needed, author and review sections of regulatory submission documents and responses to health authority questions.
- Knowledge of GMP expectations for CM&C development.
Key Leadership responsibilities:
- Work proactively with development teams to identify appropriate solutions to business and research problems.
- Effectively communicate with project team members and management.
- Identify and utilize statistical methods to deliver individual objectives in a high-quality, cost-effective manner.
Minimum Qualification (education, experience and/or training, required certifications):
- Post-graduation or Ph. D in statistics with 5 or more years in pharmaceutical process and analytical development
- Knowledge of theoretical and applied statistics, including statistical modeling, control charts, nonparametric methods, multivariate methods, and experimental design (DOE)
- Proficiency with statistical software tools (JMP, Minitab, design expert, Statistica ...)
Additional Preferences:
- Experience in a regulated environment (Pharmaceutical company, Animal or Human Health)
- Knowledge of regulatory activities and trends
- Experience working in global and agile teams.
- Experienced in applying Quality by Design principles to biologics and/or vaccine development.
- Knowledge of USDA expectations for CM&C development
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
Top Skills
What We Do
At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives.
Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society.
Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco
