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Principal Research Scientist, Bioanalytical (Large Molecule)

Elanco
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development

Role Summary

As a Principal Research Scientist within Research and Breakthrough Innovation, you will serve as the bioanalytical subject matter expert for large molecule programs. You will lead bioanalytical strategy, assay development, and execution for early research and development programs, providing critical data that advances Elanco’s innovation pipeline. This role combines deep technical leadership with cross-functional influence and mentorship.

Responsibilities

  • Lead the design, development, and implementation of bioanalytical assays (e.g., MSD, ELISA/LBA, cell-based assays) to support PK, biomarker, and immunogenicity (ADA) assessment for large molecule modalities
  • Serve as the bioanalytical lead on cross-functional project teams, providing scientific and strategic guidance from early research through clinical development
  • Mentor and develop junior scientists and provide scientific oversight to CRO partners, ensuring technical excellence and knowledge transfer
  • Oversee assay transfer, validation, and sample analysis at CROs, reviewing protocols, data, and reports for quality, compliance, and scientific rigor
  • Champion new technologies, troubleshoot complex bioanalytical challenges, and ensure all activities meet regulatory and quality standards (FDA, EMA, ICH)

Qualifications

  • Required: Ph.D. in Immunology, Biochemistry, or related field with 5+ years of relevant industry experience, or M.S. with 8+ years of relevant industry experience, or B.S. with 10+ years of relevant industry experience
  • Required: Extensive hands-on experience developing and executing PK and immunogenicity assays for large molecule therapeutics
  • Required: Demonstrated understanding and application of global bioanalytical regulatory guidelines
  • Required: Proven ability to lead bioanalytical workstreams in a matrixed, cross-functional environment
  • Preferred: Experience managing and overseeing bioanalytical activities at CROs
  • Preferred: Biomarker assay development experience
  • Preferred: Strong people leadership skills with a track record of mentoring and developing scientific talent
  • Preferred: Excellent written and verbal communication skills, with the ability to clearly convey complex scientific and regulatory concepts

Additional Requirements

  • Location: Global Elanco Headquarters – Indianapolis, IN | Hybrid work environment
  • Travel: Limited, as required