(Associate) Principal Bioanalysis Scientist

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.
• Experience in pharmaceuticals or biotech.
• 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.
• Experience with bioanalytical method validation per ICH M10, FDA, and EMA guidelines.
• Written and oral communication skills in English and Chinese.
• Ability to manage multiple projects and meet timelines.

Desirable

• with 10+ years, with 8+ years, or with 6+ years of pharma/biotech experience.
• Experience with single-cell sequencing, bioinformatic QC, or translational genomics is a plus.
• Familiarity with NDA/BLA submission requirements.
• Experience overseeing CRO bioanalytical activities (method transfer, audit support, data review).

Date Posted

10-6月-2026

Closing Date

30-12月-2026