Project Toxicologist
virtual vocationsNew York, NY
Project Toxicologist
virtual vocationsNew York, NY
today
Occupations
Medical Scientists, Except EpidemiologistsOccupational Health and Safety SpecialistsEnvironmental Scientists and Specialists, Including HealthIndustries
Biological Product (except Diagnostic) ManufacturingResearch and Development in Biotechnology (except Nanobiotechnology)Pharmaceutical Preparation ManufacturingAbout the role
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 developmentRequired 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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JOB OVERVIEW
Experience level
Senior
Location
New York, NY
Occupation
Medical Scientists, Except Epidemiologists
Industry
Biological Product (except Diagnostic) Manufacturing
Posted
today
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