12 дней назад
Scientist, Immunogenicity Bioanalytical
109 020 - 147 498$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Scientist, Immunogenicity Bioanalytical (Biotech): Developing, validating, and implementing anti-drug antibody and pre-existing antibody assays for nonclinical and clinical studies with an accent on regulatory compliance, assay robustness, and immunogenicity risk assessment. Focus on designing novel assay formats, resolving molecule-specific assay challenges, interpreting bioanalytical data, and overseeing internal and external laboratory work.
Location: Thousand Oaks, California, United States; lab-based
Salary: $109,020.15–$147,497.85 annual base salary
Company
is a biotechnology company developing, manufacturing, and delivering medicines across oncology, inflammation, general medicine, rare disease, and obesity-related conditions.
What you will do
- Develop, optimize, validate, and implement anti-drug antibody and pre-existing antibody assays for nonclinical and clinical studies.
- Conduct regulated sample analysis in accordance with GLP and GCP guidelines using bioanalytical platforms such as electrochemiluminescence-based MSD.
- Design mitigation strategies for high drug concentrations, soluble target interference, pre-existing reactivity, matrix effects, and other molecule-specific assay challenges.
- Author and review validation reports, sample analysis reports, scientific documents, presentations, and project materials.
- Provide scientific oversight of internal bioanalysis and work performed by external CRO laboratories.
- Evaluate new technologies and methodologies while supporting immunogenicity risk assessment, regulatory submissions, and candidate selection.
Requirements
- PhD, or a master’s degree with 2 years of immunogenicity bioanalytical experience, or a bachelor’s degree with 4 years of immunogenicity bioanalytical experience.
- Experience with immunology, immunogenicity, antibody biology, or a related field.
- Experience with regulated bioanalytical assay execution and method transfer to external contract laboratories.
- Ability to resolve scientific challenges, prioritize effectively, and manage multiple projects in a high-workload environment.
- Strong scientific problem-solving, project management, time management, and collaboration skills.
Nice to have
- Pharmaceutical or biotechnology industry experience.
- Prior GLP and GCP experience.
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.
- Discretionary annual bonus program and stock-based long-term incentives.
- Time-off plans and career development opportunities.
Hiring process
- Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
- Sponsorship is not guaranteed.
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