Upstream QbD Development Scientist

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: Advisor - Upstream Product Development As the Advisor for Upstream Product Development, you will be a key technical leader within our Technical Development (TD) organization. You will play a critical role in advancing Elanco’s pipeline by developing and embedding Quality by Design (QbD) principles into our upstream processes. In this role, you will be responsible for advancing how we mature molecules from clone selection through to process validation, ensuring quality and robustness are built into our products from the very beginning. You will partner closely with colleagues in manufacturing, statistics, and cell line development to deliver the next generation of animal health solutions.

Requirements

• Education: Bachelor's Degree in Engineering, Biology, Biochemistry, or a related biotechnology field, or a High School Diploma/GED with an equivalent level of experience.
• Experience: A minimum of 5 years of experience in mammalian cell culture for large molecule product streams (e.g., Monoclonal Antibodies, Proteins, Antigens).
• Top Skills: Demonstrated experience in developing control strategies for upstream processes and designing experiments using statistical approaches; proven ability to lead, influence, and collaborate with cross-functional teams.

Nice To Haves

• Advanced degree (MS or PhD) in a relevant scientific field.
• Strong problem-solving abilities, with a track record of strategic and creative thinking to resolve complex technical challenges.
• Broad understanding of multiple technology platforms, such as fermentation, purification, and analytical method development.
• Previous experience in the Animal Health industry.
• Experience with cell culture scale-up, technology transfer, and working in regulated (cGMP, USDA) environments.

Responsibilities

• Lead and mentor a team of scientists, guiding their professional growth and directing their work in upstream process development and Quality by Design (QbD) implementation.
• Develop and own the strategic framework for process control, including creating and refining workflows, risk assessment methodologies, and technical reporting templates.
• Drive cross-functional alignment by collaborating with Manufacturing, Regulatory, Quality, and Cell Line Development teams to ensure process capabilities and control strategies meet internal and external standards.
• Serve as the subject matter expert for upstream QbD, designing statistically robust experiments and communicating best practices through technical reports and presentations.
• Ensure the integration of control strategies across the entire bioprocess, connecting upstream development with downstream, formulation, and analytical teams to create a holistic approach.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level