Senior Scientist, Downstream Process Development

Elanco; Indianapolis (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

8-week parental leave

Annual bonus offering

Up to 6% 401(k) matching

Flexible work arrangements

Job summary

Elanco, a global leader in animal health, is seeking a Senior Scientist for Downstream Process Development in Indianapolis, IN. This role focuses on the development and launch of new biological drug substances, particularly monoclonal antibodies and therapeutic proteins. The candidate will lead process development activities, ensuring successful tech transfers and commercialization while collaborating across multiple departments.

The ideal candidate has a MSc or PhD in a related field with significant experience in downstream biologics process development, a strong grasp of protein purification, and leadership skills. This position promotes a hybrid work environment and robust benefits.

Qualifications

• Minimum 7 years of experience in downstream biologics process development with PhD.
• Strong understanding of protein purification and experience with regulatory filing procedures.
• Experience with phase-appropriate development strategies.

Responsibilities

• Lead downstream process development for early- and late-stage biologic programs.
• Apply Quality by Design principles to process characterization.
• Author and review regulatory submission documents.

Skills

Protein purification development

Tech transfer experience

Leadership skills

Education

MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, or chemical engineering

Job description

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: Senior Scientist, Downstream Process Development

The Biopharma Technical Development team located in Indianapolis, IN is seeking a Senior Research Scientist to provide 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 be responsible for leading downstream process development activities at bench and pilot scales, supporting scale‑up, technical transfers, process implementation, and clinical material production at both internal and external manufacturing sites. In addition to technical excellence, this position requires strong organizational management, communication skills, and cross‑functional collaboration across departments and geographies. As a subject‑matter expert in downstream process development, you will have the potential to lead both projects and people.

Your Responsibilities:

• Provide scientific expertise in downstream process development for early‑ and late‑stage biologic programs (mAbs, therapeutic proteins, and other modalities) using phase‑appropriate development strategies.
• Apply Quality by Design (QbD) principles to process development and process characterization.
• Lead and contribute to risk assessments supporting product development stage‑gate reviews and robust manufacturing control strategies.
• Develop representative scale‑down models from commercial‑scale operations and apply prior knowledge to guide development studies.
• Author and review source documents for regulatory submissions; respond to CMC questions from regulatory agencies.
• Partner with R&D, Technical Services/Manufacturing Sciences (TS/MS), supply chain, Quality, Manufacturing, Launch Leaders, external CDMOs, and other stakeholders to ensure successful tech transfers and commercialization.
• Serve as a technical resource to Biopharma Technical Development, TS/MS, CMOs, and manufacturing operations.

What You Need to Succeed (Minimum Qualifications):

• Education: MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, or chemical engineering. Equivalent experience may be considered.
• Experience: Minimum 7 years (PhD) or 12+ years (MSc) in downstream biologics process development (preferably mammalian cell culture‑based products) or equivalent late‑stage/commercialization experience in biological or pharmaceutical products.
• Top 2 Skills: Strong understanding of protein purification development process and hands‑on experience (therapeutics, protein modality, or gene therapy); experience with tech transfer and regulatory filing procedures.

What Will Give You a Competitive Edge (Preferred Qualifications):

• Strong understanding of GMP and Quality by Design (QbD) principles; experience with AI/ML applications a plus.
• Demonstrated success in developing or commercializing biologics, pharmaceuticals, or vaccines.
• Strong interpersonal and leadership skills, with the ability to influence stakeholders and lead interdisciplinary teams.
• Proven ability to manage multiple priorities, navigate ambiguity, and deliver clear scientific/technical writing and presentations.
• Experience in animal health (advantageous but not required).

Additional Information:

• Travel: 10–20% (domestic and international)
• Location: Indianapolis, IN – Hybrid Work Environment

Elanco Benefits and Perks:

• 8‑week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Up to 6% 401(k) matching
• Multiple relocation packages
• Two weeklong shutdowns (mid‑summer and year‑end) in the US (in addition to PTO)
• Flexible work arrangements

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.

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see the Elanco Workforce Privacy Notice.