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(Associate) Principal Bioanalysis ScientistAstraZeneca · Shanghai Jing'An Office
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AstraZeneca

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(Associate) Principal Bioanalysis Scientist

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🗓️ Posted 2026-09-29 Shanghai Jing'An Office Full-time Hybrid Science Technology
💰 Salary Not shared 📊 Market NA

About the Company

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio Pharmaceutical Manufacturing Specialties: Pharmaceutical, Biopharmaceutical, Innovation, Research and development, Global business

Responsibilities

  • ● The Bioanalysis Laboratory supports AstraZeneca R&D China by generating quality-compliant PK, PD, ADA, NAb, and biomarker data for cell therapy projects, biotherapeutic development and regulatory filing.
  • ● The Associate Principal or Principal Bioanalysis Scientist is responsible for:
  • ● Leading clinical bioanalysis projects as principal investigator: development, qualification/validation, and implementation of PCR-based (VCN, RCL), LBA (ELISA, MSD)and flow cytometry assays in a GxP environment.
  • ● Managing in-house and outsourced bioanalytical studies in collaboration with internal teams and CROs.
  • ● Supporting lab management to optimize operations and expand bioanalytical capability.
  • ● The job title and grade offered will be commensurate with the successful candidate's experience and qualifications
  • ● Typical Accountabilities
  • ● Collaborate with US/UK bioanalytical teams for PK/IMG/PD/Biomarker assay transfer, troubleshooting, validation, sample testing, and reporting.
  • ● Design, execute, and review experiments for development and validation of ddPCR or qPCR (VCN, RCL), LBA (ELISA, MSD), and flow cytometry (absolute counting, immunophenotyping, receptor occupancy, functional assays) methods.
  • ● Review and approve sample analysis data, method validation protocols/reports, bioanalytical sample testing reports, NDA/BLA dossier sections, and SOPs in compliance with GLP/GCP requirements.
  • ● Mentor junior scientists on experiment planning, troubleshooting, and data interpretation.
  • ● Present results at team/department meetings; prepare controlled documents, study plans, reports, and regulatory submission contributions.
  • ● Manage resources and timelines to ensure on-schedule delivery. Essential
  • ● Degree in Biology, Biochemistry, Pharmacology, or related field.
  • ● Hands-on experience developing and validating LBA (ELISA, MSD), ddPCR/qPCR (VCN, RCL), and multi-parameter flow cytometry assays (cell counting, immunophenotyping, functional/intracellular staining) in a GxP environment.
  • ● Written and oral communication skills in English and Chinese.
  • ● Ability to manage multiple projects and meet timelines. Desirable
  • ● B.Sc. with 10+ years, M.Sc. with 8+ years, or Ph.D. with 6+ years of pharma/biotech experience.
  • ● Familiarity with NDA/BLA submission requirements.
  • ● Date Posted 29-9月-2026