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10 дней назад

Senior Scientist II - Biomarker

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
China
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
Senior Scientist II - Biomarker (Bioanalysis/Cell & Gene Therapy): Leading biomarker and bioanalytical strategies for clinical programs, developing complex assays, and supporting regulated laboratory workflows with an accent on PCR/ddPCR, immunoassays, and method qualification. Focus on solving advanced technical issues, transferring methods, interpreting complex data, and mentoring laboratory staff while ensuring GLP/GCLP compliance and data quality.

Location: SIMZ Pudong, Shanghai, China

Company

hirify.global provides laboratory services, diagnostics, data, and technology solutions for healthcare providers, researchers, pharmaceutical companies, and health systems.

What you will do

  • Lead biomarker and bioanalytical strategies for clinical programs and collaborate with internal teams and external sponsors.
  • Design, develop, qualify, and optimize complex biomarker assays and fit-for-purpose bioanalytical frameworks.
  • Execute advanced workflows using PCR, ddPCR, immunoassay, and emerging analytical platforms.
  • Resolve complex technical issues through troubleshooting experiments, root-cause analysis, and data interpretation.
  • Support biologics and Cell & Gene Therapy programs, including technology transfer and method transfer activities.
  • Mentor junior and mid-level staff, coordinate complex workflows, and contribute to training and process improvement.

Requirements

  • Bachelor’s degree in biology, chemistry, pharmacy, pharmaceutical analysis, or a related field.
  • At least 6 years of experience in biomarker assays.
  • Strong laboratory experience with clinical and non-clinical biomarker assays, including PCR/ddPCR and immunoassay platforms.
  • Experience with method development, optimization, qualification, validation, transfer, and advanced troubleshooting.
  • Knowledge of GLP, GCP, GCLP, SOPs, regulatory requirements, data integrity, risk escalation, and CAPA.
  • Ability to independently solve complex technical problems, interpret complex datasets, communicate effectively, and mentor laboratory staff.

Nice to have

  • Experience supporting biologics and Cell & Gene Therapy programs through preclinical and IND-enabling stages.
  • Expertise in PK, PD, biodistribution, viral shedding, and immunogenicity assays.
  • Experience with soluble proteins, gene expression, viral loading, rare mutation detection, matrix effects, and low-abundance analytes.

Culture & Benefits

  • Work in a global laboratory services and healthcare environment.
  • Contribute to diagnostic, pharmaceutical, and clinical research programs.
  • Participate in scientific innovation, technology implementation, and process improvement.
  • Equal opportunity workplace with an inclusive and non-discriminatory employment policy.

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