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2 дня назад

Principal Scientist, Immunogenicity and Ligand Binding Assays (mRNA-LNP)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
UK
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
Principal Scientist, Immunogenicity and Ligand Binding Assays (mRNA-LNP): Leading regulated immunogenicity and ligand binding assay bioanalysis for Moderna's mRNA-LNP therapeutic pipeline with an accent on assay development, validation, clinical sample analysis, and regulatory support. Focus on designing phase-appropriate bioanalytical strategies, overseeing ADA and neutralizing antibody assays, and ensuring GcLP, GLP, and GCP compliance.

Location: Oxford, England, United Kingdom; hirify.global follows a 70/30 work model with 70% in-office collaboration.

Company

hirify.global develops mRNA medicines through its mRNA technology platform and therapeutic pipeline.

What you will do

  • Provide scientific and hands-on oversight of ligand binding assay bioanalysis for mRNA-LNP therapeutic development programs.
  • Design and execute phase-appropriate, risk-based clinical bioanalytical strategies across clinical development stages.
  • Lead regulated development, validation, and clinical sample testing for anti-drug antibody and neutralizing antibody assays.
  • Drive development and implementation of cell-based assays, immunoassays, translated-protein quantitation, PK assays, and PD assays.
  • Review analytical data, validation results, and study reports to ensure scientific integrity, data quality, and regulatory compliance.
  • Collaborate with internal and external stakeholders, contribute to regulatory submissions, and support responses to regulatory authorities.

Requirements

  • Ph.D. in infectious disease, immuno-oncology, immunology, cancer biology, or a related field, plus 10+ years of industry biotechnology or pharmaceutical experience; an M.S. with extensive bioanalytical experience may be considered.
  • Experience with clinical assay platforms including ECL, Gyrolab, reporter gene assays, DELFIA assays, and related methodologies.
  • Knowledge of GLP requirements, regulatory expectations, and current bioanalytical industry practices.
  • Ability to communicate scientific concepts, program objectives, and data analysis in a matrix environment.
  • Experience with RNA, biologics, and cell therapy is preferred.
  • Experience with Watson LIMS and LabVantage eLBN is advantageous.

Culture & Benefits

  • In-person collaboration model emphasizing innovation, teamwork, and direct mentorship.
  • Healthcare coverage and voluntary benefit programs.
  • Fitness, mindfulness, and mental health support.
  • Family-building benefits, including fertility, adoption, and surrogacy support.
  • Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and year-end shutdown.
  • Savings and investment programs, with additional location-specific benefits.

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