Senior Research Scientist Companion Animal Products Elanco

Company Name:
Company Overview:
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 1,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
This position is responsible for CMC (Chemistry, Manufacturing, and Controls) activities associated with the development of companion animal veterinary products.
Responsibilities include pre- formulation development, formulation development and drug product process scale-up, authoring non-GMP and GMP study protocols/reports and authoring of regulatory submissions in coordination with regulatory affairs personnel.
This position is expected to incorporate Quality by Design (QbD) principles throughout development.
This role identifies, selects and establishes contract agreements with Contract Research/Manufacturing Organization (CRO/CMO) activities and provides oversight and coordination of work conducted with these 3 rd parties.
This position must understand and have a strong working knowledge of GMPs and industry/global regulatory guidelines, such as VICH and ICH .
This role will work closely with manufacturing during the commercialization process and should have a basic understand the analytical chemistry requirements for drug product development.
Basic Qualifications:
Masters Degree in Science with a minimum 5 years experience in pharmaceutical drug product/drug substance development and process scale-up with demonstrated record of success.
PhD with a minimum 3 years experience in pharmaceutical drug product /drug substance development and process scale-up with demonstrated record of success. Demonstrated technical leadership and problem solving
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Additional Skills/Preferences:
Experience with liquid formulations, sterile products or bioproducts (proteins) is desirable.
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