Consultant - Product Development
Listed on 2026-10-19
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Research/Development
Regulatory Compliance Specialist
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!
About Elanco Making animals' lives better makes life better - join our team today! 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. 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 where new ways of thinking are championed, dynamic teams collaborate, and individuals acquire skills to propel their careers to new heights.
The Biopharma Technical Development team located in Indianapolis, IN is seeking a Scientist responsible for providing scientific and technical expertise for the development and launch of new biological drug substances in an innovative and fast-paced organization. This role is focused on downstream process development with an emphasis on monoclonal antibodies, therapeutic proteins, and other biological modalities. You will design and execute downstream process development activities at bench and pilot scales, support scale-up, technical transfers, process implementation, and clinical material production at both internal and external manufacturing sites.
Beyond technical execution, this position requires strong organizational management, excellent communication skills, and cross-functional collaboration across departments and geographies.
- Downstream Process Development & Experimentation:
Design and conduct downstream process development experiments supporting early- and late-stage biological programs (monoclonal antibodies, therapeutic proteins, and other modalities). - Apply principles of Quality by Design (QbD) to process development, process characterization, and risk mitigation.
- Serve as a key downstream technical resource for Biopharma Technical Development, TS/MS, and commercial manufacturing teams.
- Scale-Up, Tech Transfer & Implementation:
Support scale-up and technology transfer activities to both internal manufacturing sites and external CDMO/CRO partners. - Support process implementation and clinical material production runs across bench, pilot, and manufacturing scales.
- Data Analysis & Technical Documentation:
Review, interpret, and present process and analytical data clearly to key project stakeholders and leadership. - Author, review, and edit critical source documents, including risk assessments, development reports, batch records, and regulatory support documentation.
- Education:
Bachelor’s (B.S.) or Master’s (M.S.) degree in Chemistry, Biology, Microbiology, Biochemistry, Chemical Engineering, or a related scientific discipline. - Experience:
M.S. with 0–2 years of relevant, hands-on laboratory experience (industry or academic); OR…
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