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 Senior Research Scientist is responsible for the development, qualification/validation, and use of analytical, bioanalytical and characterization methods in support of Elanco’s Food and Companion Animal Vaccine product development. This role is expected to benchmark the Animal Health industry
and drive the change to put Elanco at the Innovation forefront. This lead scientist will additionally be charged with creating a culture of intellectual curiosity that implements best practices of QbD and drives the analytical development for successful release of vaccine.
Functions, Duties, Tasks:
- Lead development for the vaccines analytical control strategy. Benchmark against the industrystandards and partner with Regulatory and Quality to align and define the registration strategy.
- Establish the analytical capability that creates a strategic advantage against industry peers.
- Partner with Global Vaccine Strategy (R&D, QC, Regulatory and Manufacturing)
- Transfer of methods to Quality Control, or third-party personnel.
- Development and verification/qualification/validation of analytical methods to support in- process, release, characterization analysis, and stability testing of antigen ingredient and final vaccine.
- Write, review, and/or approve high quality technical reports, SOPs, analytical methods, global regulatory submissions, and responses to questions.
- Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP, and GMP requirements.
Minimum Qualification (education, experience and/or training, required certifications):
- Ph.D. in analytical, biophysical, biochemistry, molecular/cell biology, or related field; alternatively, skills commensurate with a PhD scientist. Minimum 3-8 years’ experience in relevant/applicable field.
- 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 skills including strategic thinking and decision-making.
- Effective oral and written communication skills.
- Must be able to work productively in an interdisciplinary team environment.
- Ability to work successfully in international or multi-cultural settings.
- Ability to handle multiple priorities and deal with ambiguity.
- Experience with assay development in the Animal Health industry is highly desired.
- Experience with the vaccine development process, including knowledge of regulatory compliance issues.
- Fundamental knowledge of cGMP/GLP/USDA compliance requirements.
- Experience with partnering and leading teams remotely.
- Position will require up to 25% travel.
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