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7 дней назад

Scientist, Immunoassays (Biotechnology)

96 267 - 126 351$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
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, Immunoassays (Biotechnology): Developing, qualifying, validating, and supporting immunogenicity and biomarker assays for preclinical and clinical cell and gene therapy programs with an accent on ADA assays, ELISA, MSD, and Luminex platforms. Focus on troubleshooting assay methods, analyzing samples and data, preparing regulatory documentation, and supporting method transfer in FDA-, EMA-, ICH-, GLP-, and GXP-aligned environments.

Location: Onsite in Somerset, New Jersey, United States. Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.

Base pay: $96,267–$126,351 USD per year, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a biotechnology company developing cell and gene therapies, including CAR-T, TCR-T, and natural killer cell-based therapies.

What you will do

  • Develop, qualify, validate, and support soluble biomarker and immunogenicity assays using ELISA, MSD, and Luminex ligand-binding platforms.
  • Troubleshoot assay-related issues and optimize methods with minimal guidance.
  • Analyze non-clinical and clinical samples and interpret data using relevant analytical software.
  • Prepare and review assay protocols, validation plans, reports, SOPs, and technical documentation.
  • Manage sample coordination, receipt, reconciliation, chain of custody, LIMS records, and ELN documentation.
  • Collaborate with scientists, study managers, and cross-functional teams on method transfer, assay implementation, program timelines, and continuous improvement.

Requirements

  • PhD in Biology, Immunology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related field with 0–3 years of relevant industry experience, or a master's degree in a related discipline with 6–8 years of relevant industry experience.
  • 2–6 years of hands-on experience developing and validating biomarker and anti-drug antibody assays.
  • Hands-on experience with ELISA, MSD, and Luminex platforms.
  • Experience analyzing non-clinical and clinical samples in a regulated clinical, research, pharmaceutical, or diagnostic laboratory.
  • Experience using LIMS and ELN for sample logistics, documentation, and inventory management.
  • Understanding of FDA and ICH guidelines for ligand-binding immunoassay qualification and validation, plus willingness to use PPE and handle biological specimens and hazardous materials safely.

Nice to have

  • Working knowledge of AI technologies and approved AI tools, with responsible use, human oversight, and compliance with organizational policies.

Culture & Benefits

  • Permanent full-time employees receive medical, dental, and vision insurance.
  • 401(k) retirement plan with a company match that fully vests on day one.
  • Eight weeks of paid parental leave after three months of employment.
  • Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
  • Additional benefits include flexible spending and health savings accounts, disability coverage, commuter benefits, family planning resources, and well-being programs.

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