Immunogenicity Principal Scientist
Zoetis
Full-time
Remote friendly (United States)
United States
$111,000 - $181,000 USD yearly
Clinical Research and Development
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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