Immunogenicity Principal Scientist

Role Summary

The Zoetis Veterinary Medicine Research & Development (VMRD) is seeking a scientist to join our team to provide immunogenicity support for novel protein therapeutics for veterinary medicine. The successful candidate will be primarily responsible for providing oversight of the immunogenicity testing and interpretation strategy across multiple biotherapeutic programs. This position will require a highly motivated and independent leader who can effectively collaborate with cross-discipline team members to advance projects.

Responsibilities

• Develop immunogenicity assessment strategy for biotherapeutic candidates consistent with the immunogenicity risk assessment and with applicable guidance and best practices.
• Collaborate with bioanalytical scientists in the development of ADA and NAb assay methods.
• Support pre-clinical, safety and clinical teams conducting in vivo studies to ensure appropriate testing of immunogenicity.
• Interpret and present immunogenicity data and provide assessment of potential clinical impact to project teams and management.
• Author components of study reports, regulatory submissions, and technical documents
• Work collaboratively and communicate effectively with multidisciplinary teams to design and prosecute studies in line with the strategic direction of the project.
• Self-starter, able to prioritize work, adapt to shifting priorities, and work efficiently with minimal supervision.

Qualifications

• Ph.D in immunology, pharmacology, biochemistry or related field with 4 or more years of relevant pharmaceutical development experience
• Proven industry experience in assessing immunogenicity of biotherapeutics with demonstrated publication record on the topic.
• In-depth understanding of the innate and adaptive immune system.
• Detailed knowledge of various bioanalytical assays used to measure the immune response.
• Excellent verbal and written communication skills.
• Detailed knowledge of global regulatory guidelines related to immunogenicity assessments.

Skills

• Desirable: Knowledge of immunogenicity prediction tools and assays.
• Desirable: Background in statistical analysis of cut points.
• Desirable: Experience interacting with regulatory agencies.

Education

• Ph.D in immunology, pharmacology, biochemistry or related field (same as qualifications)