[Remote] Immunogenicity Principal Scientist at Zoetis

Michigan, United States

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Ph.D. in immunology, pharmacology, biochemistry, or related field
4+ years of relevant pharmaceutical development experience
Proven industry experience in assessing immunogenicity of biotherapeutics
Demonstrated publication record on immunogenicity
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

Develop immunogenicity assessment strategy for biotherapeutic candidates
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 immunogenicity testing
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
Be a self-starter, able to prioritize work, adapt to shifting priorities, and work efficiently with minimal supervision