Job Description

At Elanco (NYSE: ELAN) \xe2\x80\x93 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\xe2\x80\x99re driven by our vision of \xe2\x80\x98Food and Companionship Enriching Life\xe2\x80\x99 and our approach to sustainability \xe2\x80\x93 the Elanco Healthy Purpose\xe2\x84\xa2 \xe2\x80\x93 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\xe2\x80\x99ll 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\xe2\x80\x99 lives better makes life better \xe2\x80\x93 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

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