2 дня назад
Principal Scientist, Project Toxicologist (Biotech)
152 224 - 205 951$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Principal Scientist, Project Toxicologist (Biotech): Developing, validating, transferring, and implementing immunogenicity assays for anti-drug binding and neutralizing antibodies supporting preclinical and clinical studies with an accent on regulatory compliance, statistical validation, and CRO oversight. Focus on interpreting complex data, troubleshooting assay performance, assessing program risks, and guiding multidisciplinary teams.
Location: United States - Remote
Salary: USD 152,224.80–205,951.20 annually
Company
is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Provide scientific and strategic leadership for immunogenicity assay development, validation, transfer, and implementation across nonclinical and clinical programs.
- Act as a senior subject-matter expert for ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assays.
- Interpret complex data, troubleshoot assay issues, and conduct risk assessments to support bioanalytical strategy.
- Oversee assay transfers to global bioanalytical CROs while maintaining scientific quality, compliance, and timelines.
- Collaborate with drug development, research, compliance, outsourcing, and cross-functional program teams.
- Mentor scientists and contribute to capability building, innovation, and best-practice development.
Requirements
- Doctorate in biochemistry, molecular biology, cell biology, immunology, or a related field with 3 years of scientific or technical industry experience; or a master’s degree with 6 years; or a bachelor’s degree with 8 years.
- Expertise in developing, validating, and overseeing immunogenicity assays for anti-drug binding and neutralizing antibodies.
- Knowledge of global regulatory guidance, GLP, GCP, and statistical approaches for assay validation.
- Experience transferring assays to bioanalytical CROs and working in matrixed, cross-functional environments.
- Experience with drug-tolerant, cell-based, predictive immunogenicity, and ligand-binding assay formats.
- Strong data analysis, troubleshooting, communication, collaboration, project management, supervisory, and mentoring skills.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
- Flexible work models where applicable.
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