Elanco · 5 months ago
Principal Scientist, Downstream Biologics
Indianapolis, IN
Full-time
Hybrid
Senior Level, Lead/Staff
7+ years expElanco is a global leader in animal health dedicated to innovation and delivering products and services for the health of farm animals and pets. They are seeking a Senior / Principal Scientist to lead downstream process development for biological drug substances, focusing on monoclonal antibodies and therapeutic proteins, while collaborating across various departments to ensure successful tech transfers and commercialization.
ManufacturingPetSupply Chain Management
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
Qualification
Required
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/pharmaceutical products
Top 2 Skills: Strong understanding of protein purification development process and done this hands on (therapeutics, protein modality, or gene therapy) and worked on tech transfer process and transferred to a manufacturing facility while also gone through a regulatory filing procedure
Preferred
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)
Benefits
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Company
Elanco
Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being.
5001-10000 employees
H1B Sponsorship
Elanco has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
Funding
Current Stage
Public CompanyTotal Funding
$252.86MKey Investors
AncoraBill & Melinda Gates Foundation
2023-12-30Post Ipo Equity· $250M
2018-09-19IPO
2017-05-24Grant· $2.86M
Leadership Team
Dave Kinard
Executive Vice President Human Resources, Corporate Affairs & Administration
Jennifer Black
Senior Director, Global Indirect Procurement
Recent News
2026-01-03
2025-12-18
Company data provided by crunchbase