Scientist, Analytical Development

Elanco•Indianapolis, IN

1d•Hybrid

About The Position

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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. 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! Your Role: Scientist, Analytical Development As a Scientist in the Biopharma Technical Development (BTD) Analytical group, you will be a key contributor to the advancement of Elanco's pipeline of monoclonal antibodies and therapeutic vaccines. In this role, you'll be responsible for providing critical analytical oversight for projects, beginning with technical transfer and continuing through validation and routine testing. You will work collaboratively with CMC teams and senior leadership, applying your technical expertise to guide project strategy and ensure the successful delivery of materials for clinical trials and commercial supply.

Requirements

Education: Ph.D. in biology, analytical chemistry, biochemistry, or a related field with a minimum of 2 years of experience in the pharmaceutical industry; OR M.S. in a related field with a minimum of 4 years of experience; OR B.S. in a related field with a minimum of 8 years of experience.
Required Experience: A minimum of 2 years (Ph.D.), 4 years (M.S.), or 8 years (B.S.) of experience in the pharmaceutical industry.
Top 2 skills: Demonstrated experience with the analytical method lifecycle (transfer, validation) for biologics (e.g., monoclonal antibodies, vaccines) using various techniques (e.g., HPLC, CE, ELISA); Experience managing technical relationships and projects with external vendors (CROs/CDMOs).

Nice To Haves

Thorough understanding of GMP/GRP requirements and quality systems, with experience applying them from early-phase through late-phase development.
Experience with statistical approaches to experimental design (DoE) and the ability to analyze, interpret, and document complex data.
Demonstrated ability to lead and contribute to technical risk assessments or root cause investigations.
A collaborative mindset with experience fostering connections and sharing best practices across global teams and external partners.

Responsibilities

Oversee the analytical method lifecycle, including transfer, qualification, and validation for biopharmaceutical products.
Manage technical relationships and project deliverables with external vendors, Contract Research Organizations (CROs), and Contract Development and Manufacturing Organizations (CDMOs).
Author and review key technical documents, protocols, and reports, ensuring compliance with Good Manufacturing Practice (GMP) and Good Research Practice (GRP) standards.