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4 дня назад

Bioanalytical Portfolio Scientist (Immunogenicity)

109 020 - 147 498$
Формат работы
remote (только USA)
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
Bioanalytical Portfolio Scientist (Immunogenicity): Providing scientific and technical oversight for outsourced ADA and NAb assay transfer, validation, and execution at CROs with an accent on method lifecycle management, data integrity, and regulatory compliance. Focus on troubleshooting assay performance, reviewing GLP/GCP documentation, resolving issues with cross-functional partners, and supporting regulatory activities.

Location: United States — Remote

Salary: $109,020.15–$147,497.85 annual base salary

Company

hirify.global is a biotech company developing medicines across oncology, inflammation, general medicine, and rare disease to serve patients with serious illnesses.

What you will do

  • Provide scientific and technical oversight for outsourced immunogenicity bioanalytical activities at contract research organizations.
  • Lead the transfer, validation, and execution of anti-drug antibody and neutralizing antibody assays, including cell-based and non-cell-based methods.
  • Monitor assay performance, troubleshoot issues, and support continuous improvement and method lifecycle management.
  • Review validation plans, protocols, reports, analytical data, sample analysis plans, reagents, and reference materials.
  • Collaborate with internal experts and CRO partners on issue resolution, supplier evaluation, governance, and escalation.
  • Contribute to SOPs, guidance documents, and regulatory activities.

Requirements

  • Doctorate degree, or a master’s degree with 2 years of regulated scientific laboratory experience, or a bachelor’s degree with 4 years of regulated scientific laboratory experience.
  • Expertise in immunoassay development, validation, and troubleshooting for ADA and NAb assays.
  • Knowledge of current regulatory expectations, industry best practices, and applicable scientific guidance.
  • Experience working with CROs and managing projects, issues, and processes.
  • Strong written and verbal communication, collaboration, negotiation, and influencing skills.
  • Must be based in the United States for this remote role.

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 and stock-based long-term incentives.
  • Paid time off and career development opportunities.
  • Sponsorship is not guaranteed.

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