Analytical Scientist, Large Molecule

Elanco • Indianapolis, IN

2d • Hybrid

About The Position

The Analytical Scientist – Large Molecule is part of Elanco’s R&D organization and drives the development, optimization, and implementation of chromatographic, electrophoretic, and LC/MS analytical methods for biopharmaceutical products. The role advances analytical techniques for therapeutic proteins and vaccines, supports bioprocess development, and leads method validation, qualification, and transfer across global Elanco manufacturing sites and external CRO/CDMO partners.

The position develops analytical methods for drug formulations and stability studies, supports upstream and downstream bioprocess development, and ensures methods and documentation meet data integrity, GMP, and regulatory expectations. The scientist also serves as an analytical subject matter expert on interdisciplinary teams, mentors junior staff, and prepares technical reports, SOPs, validation protocols, and regulatory submission summaries.

The role is based at Elanco’s Global Headquarters in Greenfield, Indiana, with a hybrid arrangement involving laboratory-based presence and flexible office work. Travel may be up to 10% annually for domestic or international site visits and cross-site transfers.

Requirements

• Bachelor’s degree in Analytical Chemistry, Biochemistry, Biophysics, Chemical Engineering, or a related scientific discipline.
• At least 5 years of relevant hands-on biotechnology or biopharmaceutical industry experience focused on large-molecule characterization.
• Demonstrated experience developing and validating HPLC/UPLC-based, electrophoretic, and LC/MS analytical methods for biologics.
• Strong scientific problem-solving abilities.
• Excellent written and verbal communication skills.

Nice To Haves

• Experience characterizing recombinant proteins, monoclonal antibodies, oligonucleotides, and therapeutic peptides.
• Experience leading method validation, qualification, and transfer in a cGMP-regulated environment.
• Proficiency with Design of Experiments, statistical analysis, and statistical software such as JMP.
• Experience with Electronic Laboratory Notebook platforms and chromatography data systems such as Empower.
• Ability to independently design, prioritize, and execute complex scientific studies while managing evolving project priorities.
• Familiarity with the Animal Health regulatory framework (USDA/FDA).

Responsibilities

• Design, develop, and optimize chromatographic methods, including SEC, RP-HPLC, IEX, and HIC, for therapeutic proteins and vaccine candidates.
• Develop and optimize electrophoretic methods, including CE-SDS and icIEF.
• Develop and optimize LC/MS methods, including intact mass and peptide mapping.
• Implement analytical solutions supporting diverse drug formulations, stability studies, and upstream and downstream bioprocess development.
• Lead analytical method validation, verification, qualification, and technical transfer across global Elanco sites and CRO/CDMO partners.
• Ensure methods, protocols, and documentation adhere to data integrity standards and GMP and regulatory expectations.
• Train, guide, and mentor junior scientists and technical associates.
• Serve as the analytical subject matter expert on interdisciplinary project teams, collaborating with Discovery Research, Bioprocess Development, Formulation, and Quality teams.
• Author and review technical reports, method SOPs, validation protocols, and regulatory submission summaries.
• Maintain meticulous Electronic Lab Notebook documentation and uphold laboratory safety and quality standards.

Benefits

• Competitive paid time off and two week-long company-wide U.S. shutdowns (summer and year-end).
• Up to 6% 401(k) company matching.
• Annual performance bonus eligibility.
• Eight weeks of fully paid parental leave.
• Flexible work arrangements.
• Relocation packages available for eligible candidates.
• Access to nine active global Employee Resource Groups.

What This Job Offers

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