Consultant - Product Development
Elanco
Summary
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.
Job description
Your Responsibilities
- 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.
- 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.
- 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.
What You Need to Succeed (Basic Qualifications)
- Bachelor’s (B.S.) or Master’s (M.S.) degree in Chemistry, Biology, Microbiology, Biochemistry, Chemical Engineering, or a related scientific discipline.
- M.S. with 0–2 years of relevant, hands-on laboratory experience (industry or academic); OR B.S. with 5+ years of relevant, hands-on laboratory experience (industry or academic).
- Direct experience in downstream biologics process development (preferably for mammalian cell culture-based products) or in protein purification.
- Demonstrated ability to apply scientific principles to solve process development challenges, coupled with foundational knowledge of experimental design, data analysis, and process scale-up principles.
What Will Give You a Competitive Edge (Additional Preferences)
- Direct hands-on experience developing downstream unit operations, including chromatography, UF/DF (tangential flow filtration), and standard filtration unit operations.
- Demonstrated track record in the development, process characterization, and scale-up of a biological modality to manufacturing.
- Solid understanding of upstream cell culture operations and analytical methods used to characterize biologics.
- Experience working within a cGMP regulated biopharmaceutical environment.
- Proven ability to manage multiple priorities, navigate ambiguity, and work effectively both independently and within interdisciplinary teams.
- Strong scientific/technical writing and presentation capabilities.
- Prior experience in the Animal Health industry (preferred, but not essential).
Work Environment & Travel Requirements
- Work Location: Global Elanco Headquarters, Indianapolis, IN.
- Work Arrangement: Hybrid (mix of on-site laboratory/office presence and remote work).
- Travel: Approximately 10% domestic and/or international business travel.
Requirements
- Bachelor’s (B.S.) or Master’s (M.S.) degree in Chemistry, Biology, Microbiology, Biochemistry, Chemical Engineering, or a related scientific discipline.
- M.S. with 0–2 years of relevant, hands-on laboratory experience (industry or academic); OR B.S. with 5+ years of relevant, hands-on laboratory experience (industry or academic).
- Direct experience in downstream biologics process development (preferably for mammalian cell culture-based products) or in protein purification.
- Demonstrated ability to apply scientific principles to solve process development challenges, coupled with foundational knowledge of experimental design, data analysis, and process scale-up principles.
Benefits
- Paid Time Off
- 401(k) Matching
- Annual Performance Bonus
- Paid Parental Leave
- Flexible Work Arrangements
- Relocation Assistance
- Employee Resource Groups
Company overview
Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.