Project Toxicologist
Job Summary
Serving as a senior subject-matter expert, the full-time remote Project Toxicologist will provide scientific leadership for the development and validation of immunogenicity assays for large molecule therapeutics, ensuring compliance with global regulatory guidelines and collaborating with cross-functional teams.
Key responsibilities:
- Lead the development, validation, and implementation of immunogenicity assays for clinical programs
- Oversee assay transfers to CROs and ensure scientific quality and compliance
- Mentor laboratory staff and contribute to innovation and best-practice development
Required qualifications:
- Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field with 3 years of industry experience, or a Master's degree with 6 years, or a Bachelor's degree with 8 years of relevant experience
- Expertise in immunogenicity assay development and validation according to global regulatory guidelines
- Experience with Good Laboratory Practices (GLPs) and Good Clinical Practices (GCP)
- Knowledge of statistical approaches for immunogenicity assays
- Supervisory and mentoring experience in a laboratory setting
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