Principal Research Scientist

Role Summary

Principal Research Scientist responsible for conducting groundbreaking clinical research to develop novel, effective animal health products. Lead design and validation of bioassays, develop pharmacokinetic/pharmacodynamic biomarker assay reagents, monitor scientific developments, evaluate new technologies, transfer knowledge across stages, analyze current offerings for new opportunities, and oversee multiple research projects while supervising a team.

Responsibilities

• Responsible for conducting groundbreaking clinical research, all with the goal of developing novel, effective animal health products.
• Conceptualize, design, construct, and validate cell based in vivo and in vitro bioassays to screen activity and potency of Elanco‚Äôs proprietary biotherapeutic and vaccine molecules.
• Conceptualize, design, construct, and validate cell based in vitro anti-drug antibody assays.
• Develop pharmacokinetic and pharmacodynamic biomarker assay reagents and assays, including providing subject matter expertise on the development of biopharmaceutical pre-clinical and clinical pharmacology flow schemes.
• Keep abreast of scientific developments in the field and integrate these novel developments into our research and development projects.
• Provide expertise and specialized knowledge in the evaluation of new platform technologies; determine which technologies and processes are best suited to meet Elanco‚Äôs unique needs.
• Proactively search for novel technologies or product opportunities; use specialized knowledge to establish collaborations and research programs to deliver innovative technical solutions.
• Transfer knowledge and information from research to development, from development to registration, and from registration to launch, including the preparation of internal and external publications; ensure each step follows Elanco‚Äôs company-wide standards and best practices.
• Analyze Elanco‚Äôs current product offerings and identify areas for further research and development.
• Manage and oversee multiple research projects, ensuring that each project adheres to Elanco‚Äôs standards, protocols, and best practices.
• Supervises 8 subordinates: Consultants and Senior Research Scientists.

Qualifications

• Required: Bachelor‚Äôs degree in Veterinary Science, Veterinary Medicine, Animal Science, a related field, or a foreign equivalent, plus 5 years of progressively responsible post-baccalaureate experience in a related role.
• Experience in clinical product development including regulatory requirements for drug, vaccine, and parasitology; conducting GCP and GLP studies; obtaining approvals for parasitology, small molecule drug, and vaccine projects; team management; technical writing for regulatory submissions/publications; developing clinical regulatory strategy; and parasitology technologies for farm animals.
• 25% domestic and international travel required for internal and external meetings related to project planning and implementations.

Skills

• Biotherapeutics and vaccine development
• Cell-based assay design and validation (in vitro and in vivo)
• Antibody assay development (anti-drug antibodies)
• Pharmacokinetic/pharmacodynamic assay development
• Regulatory clinical development and GxP (GCP/GLP) knowledge
• Technical writing and publication preparation
• Strategic evaluation of platform technologies
• Project management and cross-functional collaboration

Education

• Bachelor‚Äôs degree in Veterinary Science, Veterinary Medicine, Animal Science, or related field (foreign equivalent acceptable).

Additional Requirements

• Travel: 25% domestic and international travel expected for project planning and partner meetings.