Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com
The Principal Research Scientist is responsible for analytical control strategies and for leading a team in the development, qualification/validation, and use of analytical, bioanalytical and characterization methods in support of Elanco’s Food and Companion Animal Vaccine product development.
Functions, Duties, Tasks:
Develop all or portions of analytical control strategies.
Development and verification/qualification/validation of analytical methods to support in-process, release, characterization analysis, and stability testing of antigen ingredient and final vaccine.
Provide support for discovery, toxicology, cell culture, fermentation, bioassay, purification, formulation, and manufacturing.
Drive innovation for analytical methods, strategy and capabilities
Oversight for method transfers to development, QCL, or third party personnel.
Coaching, training, and administration of performance management to personnel (primarily, but not limited to, direct reports).
Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP, and GMP requirements.
Ph.D. in analytical, biophysical, biochemistry, molecular/cell biology, or related field Minimum 8 years experience in biophysical, biochemistry, molecular/cell biology field.
Experience with assay development in the Animal Health industry is highly desired
Chemistry experience with knowledge of one or more of the following, as appropriate: separation sciences, immunochemistry, biophysical/biochemical characterization, molecular biology, and bioanalytical sciences.
Problem solving and decision-making.
Demonstration of scientific leadership skills.
Effective oral and written communication skills.
Must be able to work productively in an interdisciplinary team environment
Experience with the drug development process, including knowledge of regulatory compliance issues.
Fundamental knowledge of cGMP/GLP/USDA compliance requirements.
Experience with the supervision of direct reports.
Position will require up to 25% travel. Depending upon siting, face-to-face support at the other sites is expected.
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