Immunogenicity Principal Scientist

Role Summary

Immunogenicity Principal Scientist is a scientific role focused on providing immunogenicity support for novel protein therapeutics in veterinary medicine, overseeing testing and interpretation strategies across multiple programs. The position requires a motivated, independent leader who collaborates with cross-discipline teams to advance projects.

Responsibilities

• Develop immunogenicity assessment strategy for biotherapeutic candidates consistent with immunogenicity risk assessment and 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

Desirable Skills

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