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12 дней назад

Scientist, Immunogenicity Bioanalytical

109 020 - 147 498$
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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