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
B.Sc. with 10+ years, M.Sc. with 8+ years, or Ph.D. with 6+ years of pharma/biotech experience.
Experience with single-cell sequencing, bioinformatic QC, or translational genomics is a plus.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
