AstraZeneca
Biotechnology
(Associate)PrincipalBioanalysisScientist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“(Associate) Principal Bioanalysis Scientist at AstraZeneca. Skills: Bioanalysis, Assay development, GxP environment. Lead clinical bioanalysis projects. Develop PCR-based assays”
Industry & Context.
Troubleshooting
What They're Looking For.
Must Have
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
Nice to Have
B. Sc. with 10+ years of pharma/biotech experience, M. Sc. with 8+ years of pharma/biotech experience, Ph. D. with 6+ years of pharma/biotech experience, Experience with single-cell sequencing, Bioinformatic QC experience, Translational genomics experience, Familiarity with NDALA submission requirements, Experience overseeing CRO bioanalytical activities
What You'll Do.
Lead clinical bioanalysis projects
Develop PCR-based assays
Develop flow cytometry assays
Qualify PCR-based assays
Qualify flow cytometry assays
Validate PCR-based assays
Validate flow cytometry assays
Implement PCR-based assays
Implement flow cytometry assays
Manage in-house bioanalytical studies
Manage outsourced bioanalytical studies
Collaborate with internal teams
Collaborate with CROs
Support lab management
Optimize lab operations
Expand bioanalytical capability
Collaborate with US/UK bioanalytical teams
Transfer PK/IMG/PDiomarker assays
Troubleshoot PK/IMG/PDiomarker assays
Validate PK/IMG/PDiomarker assays
Test PK/IMG/PDiomarker samples
Report PK/IMG/PDiomarker data
Develop ddPCR methods
Develop flow cytometry methods
Validate ddPCR methods
Validate qPCR methods
Validate flow cytometry methods
Review sample analysis data
Approve sample analysis data
Review method validation protocols
Approve method validation protocols
Review method validation reports
Approve method validation reports
Review bioanalytical sample testing reports
Approve bioanalytical sample testing reports
Review NDALA dossier sections
Approve NDALA dossier sections
Mentor junior scientists
Present results at team/department meetings
Prepare controlled documents
Contribute to regulatory submissions
Ensure on-schedule delivery
How You'll Work.
Team & Collaboration
Internal teams; CROs; US/UK bioanalytical teams
Communication Scope
Written communication; Oral communication; English; Chinese; Present results
Process & Methodology
Manage multiple projects, Manage timelines
Full Job Description
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/intrac
Applying for this (Associate) Principal Bioanalysis Scientist role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about AstraZeneca?
Real rants from real employees. Read before you apply.