AstraZeneca(Associate) Principal Bioanalysis Scientist
AI in this role
Lead clinical bioanalysis projects, assay development, and validation in a GxP environment for biotherapeutic and cell therapy projects.
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.
- Familiarity with NDA/BLA submission requirements.
- Experience overseeing CRO bioanalytical activities (method transfer, audit support, data review).
Date Posted
29-9月-2026Closing Date
30-12月-2026AstraZeneca 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.
How we rate this
(Associate) Principal Bioanalysis Scientist at AstraZeneca rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Open the description and count.
Prepare for this job
A free preview built only from this posting: what it asks for, what you could be asked in an interview, and how to adjust your resume.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where bioanalysis was part of your work. What did you do?
- Tell me about a project where pharmacokinetics was part of your work. What did you do?
- Tell me about a project where gxp was part of your work. What did you do?
- Tell me about a project where biomarkers was part of your work. What did you do?
- Tell me about a project where assay validation was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Bioanalysis, Pharmacokinetics, Gxp, Biomarkers, and Assay Validation. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them — a tool named with nothing behind it rarely survives a human read.
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