Analytical Scientist, Large Molecule

Your Role

As an Analytical Scientist – Large Molecule, you will be an integral part of Elanco's R&D organization, driving the development, optimization, and implementation of chromatographic, electrophoretic, and mass spectrometry (LC/MS) analytical methods for biopharmaceutical products. In this role, you will advance state-of-the-art analytical techniques for therapeutic proteins and vaccines, support bioprocess development, and lead method validation, qualification, and transfer efforts across global internal manufacturing sites and external CRO/CDMO partners.

Your Responsibilities

• Design, develop, and optimize robust chromatographic (e.g., SEC, RP-HPLC, IEX, HIC), electrophoretic (e.g., CE-SDS, icIEF), and LC/MS (including intact mass and peptide mapping) analytical methods for therapeutic protein and vaccine candidates.
• Innovate and implement analytical solutions to support diverse drug formulations, stability studies, and upstream/downstream bioprocess development.
• Lead analytical method validation, verification, qualification, and technical transfer activities across global Elanco sites and contract research/manufacturing organizations (CROs/CDMOs).
• Ensure all analytical methods, protocols, and documentation adhere strictly to data integrity standards and GMP/regulatory expectations.
• Train, guide, and mentor junior scientists and technical associates to ensure technical consistency and high-quality analytical practices across the organization.
• Serve as the analytical subject matter expert on interdisciplinary project teams, collaborating closely with Discovery Research, Bioprocess Development, Formulation, and Quality teams.
• Author and review comprehensive technical reports, method standard operating procedures (SOPs), validation protocols, and regulatory submission summaries.
• Maintain meticulous Electronic Lab Notebook (ELN) documentation and uphold the highest laboratory safety and quality standards.

What You Need to Succeed (Basic Qualifications)

• Bachelor's Degree (B.S.) in Analytical Chemistry, Biochemistry, Biophysics, Chemical Engineering, or a related scientific discipline.
• Minimum of 5+ years of relevant hands-on experience in the biotechnology or biopharmaceutical industry focused on large-molecule characterization.
• Demonstrated track record developing and validating HPLC/UPLC-based, electrophoretic, and LC/MS analytical methods for biologics.
• Strong scientific problem-solving abilities coupled with excellent written and verbal communication skills.

What Will Give You a Competitive Edge (Additional Preferences)

• Direct experience characterizing recombinant proteins, monoclonal antibodies (mAbs), oligonucleotides, and therapeutic peptides.
• Practical experience leading method validation, qualification, and transfer within a cGMP-regulated environment.
• Proficiency with Design of Experiments (DoE), statistical analysis, and statistical software packages (e.g., JMP).
• Hands-on experience working with Electronic Laboratory Notebook (ELN) platforms and chromatography data systems (e.g., Empower).
• Demonstrated ability to independently design, prioritize, and execute complex scientific studies while navigating evolving project priorities.
• Prior background or familiarity with the Animal Health regulatory framework (USDA/FDA) is a plus.

Work Environment & Travel Requirements

• Work Location: Global Elanco Headquarters – Greenfield, IN.
• Work Arrangement: Hybrid (laboratory-based presence with flexible office work arrangements).
• Travel: Up to 10% annual domestic or international travel as needed for technical site visits and cross-site transfers.