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
Experience: 8 years required