5 дней назад
Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences (Biotech)
165 501 - 223 913$
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Описание вакансии
Текст:
TL;DR
Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences (Biotech): Designing, developing, validating, and implementing immunogenicity assays for binding and neutralizing anti-drug antibodies supporting preclinical and clinical studies with an accent on regulatory compliance, assay transfer, and multidisciplinary collaboration. Focus on interpreting complex data, troubleshooting assay performance, guiding CRO transfers, supporting regulatory filings, and mentoring laboratory scientists.
Location: Thousand Oaks, California, United States
Salary: $165,500.95–$223,913.05 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
- Lead the design, development, validation, transfer, and implementation of immunogenicity assays for nonclinical and clinical programs.
- Provide subject-matter expertise in ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assay approaches.
- Apply global regulatory guidance, GLP/GCP expectations, and statistical validation principles to program decisions.
- Interpret complex data, troubleshoot assays, assess risks, and support immunogenicity bioanalytical strategy.
- Oversee assay transfers to global bioanalytical CROs and ensure scientific quality, compliance, and delivery timelines.
- Influence cross-functional teams, mentor scientists, and contribute to capability building and best-practice development.
Requirements
- Work location: Thousand Oaks, California, United States.
- 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.
- Experience developing, validating, and overseeing immunogenicity assays for anti-drug binding and neutralizing antibodies.
- Knowledge of global regulatory guidelines, GLP, GCP, statistical approaches, drug-tolerant assays, cell-based assays, and predictive immunogenicity methods.
- Experience transferring assays to bioanalytical CROs and working in matrixed, cross-functional environments.
- Strong data interpretation, project management, communication, collaboration, and multitasking skills.
Nice to have
- Supervisory or mentoring experience in a laboratory setting.
- Experience implementing immunogenicity assay development, validation, and sample analysis across multiple projects.
Culture & Benefits
- Collaborative, innovative, and science-based working environment.
- Health, dental, vision, life, and disability insurance.
- Retirement and savings plan with company contributions and flexible spending accounts.
- Annual bonus program and stock-based long-term incentives.
- Paid time off, work-life balance support, and career development opportunities.
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